Effectiveness and Outcomes of Interventions

This section addresses subsections (G) and (H) of 399DD, which require: (G) "Information on the effectiveness and outcomes of interventions for individuals diagnosed with autism spectrum disorder, including by severity level as practicable, and other developmental disabilities and how the age of the child or other factors, such as demographic characteristics, may affect such effectiveness," and (H) "Information on the effectiveness and outcomes of innovative and newly developed intervention strategies for individuals with autism spectrum disorder or other developmental disabilities." Information on the effectiveness and outcomes of interventions is provided by ACL, AHRQ, ED, HRSA, and NIH.

Administration for Community Living

NIDILRR has funded research on interventions for people (children, transition-age youth, adults) with ASD and other DD. Studies relevant to ASD include:

• Employment interventions
  • An internship model, which includes ASD supports, to improve employment outcomes for transition-age youth with ASD
  • A customized employment intervention to improve employment outcomes for transition-age youth with ASD
  • Interventions to improve employment outcomes for people with intellectual and developmental disabilities
  • Self-Determined Career Development Model intervention to improve employment outcomes for people with intellectual and developmental disabilities
• Parent & caregivers: education and training interventions
  • Scale-up project of OASIS, a model of intervention skills training for parents of children with autism
  • Parent education program designed to meet the needs of Latino parents of children with ASD
  • An intervention that prepares youth with DD, ages 14-21, to respond to environmental barriers and increases participation in school, work, and the community
• Interventions to improve community living and participation in transition age youth and/or adults
  • A technology-supported instructional system to teach social competence, problem-solving skills, and organizational/self-monitoring skills for adolescents and young adults
  • A web application that enables individuals with intellectual disabilities and autism to effectively manage self-defined goals for everyday living
  • Project to determine if affective and physiological regulation in individuals with ASD can be promoted through dynamic adjustments in the environment
  • System to assist young adults with ASD to safely and effectively transition into independent living
  • Intervention that prepares youth with DD ages 14-21 to respond to environmental barriers and increase participation in school, work, and the community
  • Toolkits to Improve Community Living and Participation for People with Intellectual and Developmental Disabilities
  • Interventions related to community participation through self-determination, social inclusion, employment, and the direct support workforce in a variety of community living service settings including family and individual homes
• Health interventions
  • Interventions to improve health outcomes of people with DD
  • Health promotion curriculum for people with intellectual and developmental disabilities

Agency for Healthcare Research and Quality

The following awards and publications provide information on the effectiveness and outcomes of interventions for individuals with ASD.

"Reducing Disparities in Timely Autism Diagnosis through Family Navigation" proposes to test the feasibility of an intervention to decrease disparities in timely ASD diagnosis that occur at a critical point in the continuum of the delivery of ASD services for young children. The patient navigation model has been implemented to reduce institutional- and individual-level barriers to cancer diagnoses and has demonstrated efficacy in both improving adherence to follow-up visits after a screening abnormality and decreasing the time from an abnormal screen to diagnostic resolution. This study will assess a novel application of patient navigation to support families of low-income and minority children, ages 15 months to 3 years. The researchers have reframed the model from patient to family navigation and will focus on a defined episode of care, beginning with an abnormal autism screen and ending with the completion of the diagnostic assessment.

"A Deliberative Approach to Develop Autism Data Collection in Massachusetts" is a health services research grant funded in 2016 that involves a deliberative citizen jury, the majority of which are individuals on the autism spectrum, to provide guidance to the Massachusetts Executive Office of Health and Human Services regarding the creation of a statewide registry for ASD. A patient registry is a collection of standardized information about a group of patients who share a particular condition or experience. When complete, the registry will provide an integrated data system to track diagnosis, treatment, services, and outcomes for individuals with ASD, with the long-term goal of improving coordination of care and disseminating information on best practices. The registry will also provide a way to track services and outcomes for various subpopulations of autistic individuals in Massachusetts.

"Partnership for Research & Dissemination of Evidence-Based Medicine in Autism" proposes to use innovative methods to develop customized content (including videos, webisodes, and interactive media products) of existing evidence-based medicine (EBM) products for ASD. The researchers will then disseminate this content through technology-based and social media channels to enable rapid and easy downloading by targeted stakeholder audiences, including parents of children with ASD as well as teachers and health care providers of autistic individuals from underserved populations. The trans-disciplinary team proposes to extend this work and develop a highly effective, unified, and sustainable high-throughput dissemination strategy to improve the use of customized EBM products at health and educational systems, clinical practice, caregiver, and family levels.

"Enabling large-scale research on autism spectrum disorders through automated processing of EHR using natural language understanding" aims to increase the utility of electronic health records (EHR) by developing scalable and effective computational methods to capture structured data from the text contained therein. This will be particularly advantageous in advancing knowledge about ASD and other mental health disorders, where records describe symptoms and interventions that are highly individualized and are often composed of rich data not easily captured in structured templates. This project has the potential to significantly shift away from the current paradigm of relying on small-scale data from individual ASD interventions and the lack of integration between different data sources, to leveraging information from existing large-scale data sources to propose novel analyses and hypotheses.

Medical Therapies for Children with Autism Spectrum Disorder — An Update. The goal of this systematic review, published in 2017, was to evaluate the comparative effectiveness and safety of medical interventions for children with ASD. Studies of medical interventions that included at least 10 children with ASD were included. The 76 unique comparative studies meeting the inclusion criteria included 72 randomized controlled trials (RCTs), 2 non-randomized trials, and 2 retrospective cohort studies; populations, treatment approaches, and outcomes assessed varied across studies. Risperidone and aripiprazole ameliorated challenging behaviors in the short term, but with clinically significant side effects [high strength of evidence (SOE)]. Methylphenidate and atomoxetine were also associated with improvements in hyperactivity in small short-term RCTs (low SOE), with improvements maintained over 6 months for atomoxetine (low SOE for longer term effects). Methylphenidate was associated with clinically significant harms (low SOE), while atomoxetine was associated with clinically moderate harms (low SOE). Omega-3 fatty acid supplementation, N-acetylcysteine, and tetrahydrobiopterin failed to show benefits (low SOE). Evidence for other interventions and outcomes studied was insufficient. While the conduct of studies has improved considerably over time (i.e., growing number of RCTs and use of standardized measures), data on longer term (≥6 months) results and harms of most interventions are lacking. Similarly, more research is needed to understand characteristics of the child or treatment that modify outcomes, whether effectiveness of interventions generalizes across different settings such as the home or school, and how components of interventions may drive effects.

Interventions Targeting Sensory Challenges in Children with Autism Spectrum Disorder - An Update. The goal of this systematic review, published in 2017, was to evaluate the effectiveness and safety of interventions targeting sensory challenges in children with ASD. Studies included 20 RCTs, 1 nonrandomized trial, and 3 retrospective cohort studies (3 low, 10 moderate, and 11 high risk of bias); populations, intervention approaches, and outcomes assessed varied across studies. Some interventions targeting sensory challenges may produce modest short-term (<6 months) improvements, primarily in sensory-related outcomes and outcomes related to ASD symptom severity; however, the evidence base for any category of intervention is small, and durability of effects beyond the immediate intervention period is unclear. Sensory integration–based approaches improved outcomes related to sensory challenges (low SOE) and motor skills (low SOE), and massage improved sensory responses (low SOE) and ASD symptoms (low SOE). Environmental enrichment improved nonverbal cognitive skills (low SOE). Auditory integration–based approaches did not improve language outcomes (low SOE). Some positive effects were associated with other approaches studied (music therapy, weighted blankets), but findings in these small studies were not consistent (insufficient SOE). Data on longer term results are lacking, as are data on characteristics that modify outcomes, effectiveness of interventions across environments or contexts, and components of interventions that may drive effects. In sum, while some therapies may hold promise and warrant further study, substantial needs exist for continuing improvements in methodologic rigor in the field.

Therapies for Children With Autism Spectrum Disorder: Behavioral Interventions Update. This 2014 update of a prior systematic review of interventions for children (0–12 years) with ASD focused on recent studies of behavioral interventions. Sixty-five unique studies comprising 48 randomized trials and 17 non-randomized comparative studies (19 good, 39 fair, and 7 poor quality) were included in the analysis. The quality of studies improved compared with that reported in the earlier review; however, assessment of the SOE and confidence in the stability of effects of interventions in the face of future research, remains low for many intervention/outcome pairs. Early intervention based on high-intensity applied behavior analysis over extended timeframes was associated with improvement in cognitive functioning and language skills (moderate SOE for improvements in both outcomes) relative to community controls in some groups of young children. The magnitude of these effects varied across studies, potentially reflecting poorly understood modifying characteristics related to subgroups of children. Early intensive parent training programs modified parenting behaviors during interactions; however, data were more limited about their ability to improve developmental skills beyond language gains for some children (low SOE for positive effects on language). Social skills interventions varied in scope and intensity and showed some positive effects on social behaviors for older children in small studies (low SOE for positive effects on social skills). Studies of play/interaction-based approaches reported that joint attention interventions may demonstrate positive outcomes in preschool-age children with ASD when targeting joint attention skills (moderate SOE); data on the effects of such interventions in other areas were limited (low SOE for positive effects on play skills, language, social skills). Studies examining the effects of cognitive behavioral therapy on anxiety reported positive results in older children with IQs ≥70 (high SOE for improvements in anxiety in this population). Smaller short-term studies of other interventions reported some improvements in areas such as sleep and communication, but data were too sparse to assess their overall effectiveness. In summary, despite improvements in the quality of the included literature, a need remains for studies of interventions across settings and continued improvements in methodologic rigor. Substantial scientific advances are needed to enhance our understanding of which interventions are most effective for specific children with ASD and to isolate elements or components of interventions most associated with effects.

Genetic Testing for Developmental Disabilities, Intellectual Disability, and Autism Spectrum Disorder. This Technical Brief collects and summarizes information on genetic tests clinically available in the United States to detect genetic markers that predispose to DD. It also identifies, but does not systematically review, existing evidence addressing the tests' clinical utility. This Brief primarily focuses on patients with idiopathic or unexplained DD, particularly intellectual disability, global developmental delay, and ASD. Patient-centered health outcomes (e.g., functional or symptomatic improvement) and intermediate outcomes (e.g., changes in clinical decisions or family reproductive decisions, and the tests' diagnostic accuracy and analytic validity) are examined. A search of the Genetic Testing Registry database identified 672 laboratory-developed tests offered by 63 providers in 29 states. We also identified one test cleared by the Food and Drug Administration. Common genetic testing methods used include array comparative genomic hybridization, microarray, DNA sequencing (the Sanger method or next-generation sequencing), and polymerase chain reaction. We did not identify any studies that directly assessed the impact of genetic testing on health outcomes. Most of the clinical studies identified for indirect assessment of clinical utility are case series reporting on a test's diagnostic yield.

Screening for Autism Spectrum Disorder in Young Children, Systematic Evidence Review for the U.S. Preventive Services Task Force. This systematic review, published in 2016, examined the evidence about benefits and harms of routine screening for ASD in primary care settings, explicitly focusing on studies of screening instruments for use in young (≤36 months of age), unselected populations (e.g., universal screening approaches). The authors identified 17 unique screening studies reported in 22 papers. The most commonly studied tool was the Modified Checklist for Autism in Toddlers (M-CHAT), including the most recently available variant (M-CHAT-Revised with Follow-up [M-CHAT-R/F]), which has a positive predictive value of 48 percent in diverse populations of children ages 16 to 30 months. Forty-two studies of good and fair quality addressed interventions for young children. Among these, 20 studies overall measured cognitive outcomes and 11 reported greater benefit for the intervention group compared to the control group. Language outcomes were significantly improved in treatment versus comparison arms in 13 of 28 studies assessing language. Twelve studies focused on play and interaction and typically measured joint attention as the outcome. Nine out of 10 studies evaluating joint attention outcomes reported greater benefit in the treatment arm compared to the control arm. None of the studies focused on screen-detected children. In summary, early intensive interventions demonstrate statistically significant improvements in cognitive and language outcomes in children compared to eclectic treatments obtained in the community or other comparison groups, although the studies are generally small, and, within the studies, some children benefit while others do not. We found no studies that directly compared long-term outcomes of screened versus non-screened children. More research is needed to determine the benefits and harms of screening the general population.

Department of Education

National Center for Special Education Research (NCSER)

Through the Special Education Research Grants Program competition, the National Center for Special Education Research (NCSER) has funded a number of projects that have demonstrated positive effects on children and youth with ASD. These projects are described below.

An RCT was conducted to determine the efficacy of Joint Attention Mediated Learning (JAML), an intervention for toddlers with ASD. This intervention directly targets foundational, preverbal social-communication competencies through parent-child interactions. These early competencies include focusing on faces, taking turns, and engaging in joint attention. The researchers found that compared to children in the control group, children in the JAML group made significantly greater gains in four targeted preverbal social-communication competencies: social visual orientation (focusing on faces), reciprocity (turn taking), responding to others' joint attention overtures, and initiating joint attention. Three of these four competencies (all except initiating joint attention) continued to show significant impacts 6 months after treatment ended.

A recently completed NCSER-funded follow-up study of the RCT study of Learning Experiences–An Alternative Program for Preschoolers and Parents (LEAP) is the second in a series of studies of this comprehensive intervention on children with ASD who are in inclusive preschool classroom settings. In the LEAP program, children without ASD learn to facilitate interaction with their peers with ASD, preschool teachers use naturally-occurring classroom situations for incidental teaching, and parents receive training in behavioral teaching strategies to reduce stress at home. This second study was a follow-up study of the children who participated in the previous RCT study that found LEAP to be an effective intervention. The positive effects of prior LEAP participation were largely sustained into elementary school. In the follow-up study, children in the LEAP group had significantly higher cognitive and social skills scores than those in the control group. Exploratory analyses indicated that for children in both groups, those placed in inclusive classrooms in elementary school had significantly higher outcome scores compared to those placed in other settings. The third and recent NCSER-funded study involves an exploration of the malleable factors (e.g., staff readiness and buy-in, leadership, promotion of implementation) that predict teacher fidelity to the LEAP model following training and over time.

The Social Competence Intervention for Adolescents (SCI-A) was developed with NCSER funds to help middle school students with high-functioning ASD navigate their social environment. This intervention is a modified clinic-based intervention for use in classrooms in school-based settings. Preliminary evidence suggested that this intervention improved social skills, executive functioning, and facial-expression recognition. Adding a peer-mediated intervention to the SCI-A program further enhanced the generalization of social skills. The effect of this classroom intervention on a variety of outcomes – social problem solving, executive functioning, social perception, emotion regulation, and social communication – is now being evaluated using an RCT with middle school students. Initial results indicate that students in the intervention group experience improvements in outcomes, especially those with lower levels of cognitive functioning, at rates higher than students in the control group.

An RCT was conducted to evaluate the efficacy of peer support interventions for improving social and behavioral outcomes for high school students with severe intellectual disabilities, including those with ASD. The peer supports intervention involves one or more peers without disabilities providing social and/or academic support to a student with severe disabilities within an inclusive classroom. The peer networks intervention connects a student with severe disabilities to a peer group of four to six students who meet regularly with the support of an adult facilitator. Results indicate that students in these peer support interventions experienced increased interactions with peers, higher levels of academic engagement and social participation, and greater numbers of new friendships that were sustained over time compared to those students in the control group.

Project Summer is an intervention designed to improve transition services for high school students with disabilities and to maximize engagement in summer employment and related activities. The intervention is aimed at students with a variety of disabilities, including those with ASD. A pilot test of the intervention using an RCT indicated that youth with severe disabilities, including youth with ASD in the treatment group, were significantly more likely (i.e., 3.5 times) to participate in community-based work experiences during the summer and work more hours per week than their peers at the same schools in the control group, who did not participate in the intervention.

Rehabilitation Services Administration (RSA)

The Rehabilitation Services Administration (RSA) has analyzed data from the RSA-911, Case Service Report, for FY 2014 through FY 2017. For FY 2014-2016, the RSA-911 includes information on individuals whose service records under the Vocational Rehabilitation (VR) Services program were closed during each of those fiscal years. Service records are closed after an individual achieves an employment outcome in competitive integrated employment or supported employment and is stable for a period of at least 90 days. Service records are also closed if services provided do not result in an employment outcome competitive integrated employment or the individual chooses to exit the VR program. RSA implemented a revised RSA-911 on July 1, 2017, pursuant to amendments made to the Rehabilitation Act of 1973 by the Workforce Innovation and Opportunity Act, so the FY 2017 data include information on individuals whose cases were closed between October 1, 2016 and June 30, 2017.

RSA has provided the total number of individuals with autism as a primary or secondary cause of disability and the number of individuals whose primary disability was an intellectual disability. RSA also computed the average age at application for all individuals who were eligible for VR services and whose case service records were closed in FY 2014 – FY 2017.

Individuals Eligible for VR Services
Disability	FY 2014	FY 2015	FY 2016	FY 2017
Disability Individuals with Autism as a Primary or Secondary Cause of Disability	FY 2014 7,255	FY 2015 9,118	FY 2016 10,405	FY 2017 8,187
Disability Individuals with Intellectual Disability as the Primary Disability	FY 2014 108,730	FY 2015 111,584	FY 2016 111,156	FY 2017 77,669

Table 17. Number of individuals who were eligible for VR services and whose cases were closed in FY 2014 - FY 2017. Source: RSA-911
Note: FY 2017 includes cases that were closed between October 1, 2016 and June 30, 2017.

Average Age of Individuals Eligible for VR Services
Disability	FY 2014	FY 2015	FY 2016	FY 2017
Disability Individuals with Autism as a Primary or Secondary Cause of Disability	FY 2014 21.6	FY 2015 21.7	FY 2016 21.6	FY 2017 21.6
Disability Individuals with Intellectual Disability as the Primary Disability	FY 2014 30.4	FY 2015 30.5	FY 2016 30.3	FY 2017 30.3

Table 18. Average Age at application (in years) for individuals who were eligible for VR services and whose cases were closed in FY 2014 - FY 2017. Source: RSA-911
Note: FY 2017 includes cases that were closed between October 1, 2016 and June 30, 2017.

RSA has also analyzed the number of individuals with employment outcomes by age group, gender, and race for individuals whose primary or secondary cause of the disability was reported as Autism or whose primary disability was identified as being an ID.

Individuals with Autism and an Employment Outcome by Age at Application
Age	FY 2014	FY 2015	FY 2016	FY 2017
Age <16	FY 2014 78	FY 2015 95	FY 2016 90	FY 2017 90
Age 16-18	FY 2014 2,690	FY 2015 3,295	FY 2016 3,638	FY 2017 2,860
Age 19-24	FY 2014 2,973	FY 2015 3,738	FY 2016 4,353	FY 2017 3,413
Age 25-44	FY 2014 1,305	FY 2015 1,725	FY 2016 2,038	FY 2017 1,624
Age 45-54	FY 2014 160	FY 2015 187	FY 2016 205	FY 2017 148
Age 55-59	FY 2014 33	FY 2015 59	FY 2016 62	FY 2017 36
Age 60+	FY 2014 16	FY 2015 19	FY 2016 19	FY 2017 16
Age Total	FY 2014 7,255	FY 2015 9,118	FY 2016 10,405	FY 2017 8,187

Table 19. Individuals with Autism as a Primary or Secondary Cause of Disability and an Employment Outcome by Age at Application: FY 2014 - FY 2017. Source: RSA-911
Note: FY 2017 includes cases that were closed between October 1, 2016 and June 30, 2017.

Individuals with Intellectual Disability and an Employment Outcome by Age at Application
Age	FY 2014	FY 2015	FY 2016	FY 2017
Age <16	FY 2014 725	FY 2015 680	FY 2016 692	FY 2017 535
Age 16-18	FY 2014 29,352	FY 2015 29,764	FY 2016 30,201	FY 2017 21,720
Age 19-24	FY 2014 23,770	FY 2015 24,403	FY 2016 24,201	FY 2017 16,466
Age 25-44	FY 2014 35,045	FY 2015 36,185	FY 2016 35,597	FY 2017 24,740
Age 45-54	FY 2014 14,582	FY 2015 14,719	FY 2016 14,188	FY 2017 9,660
Age 55-59	FY 2014 3,767	FY 2015 4,235	FY 2016 4,386	FY 2017 3,112
Age 60+	FY 2014 1,489	FY 2015 1,598	FY 2016 1,891	FY 2017 1,436
Age Total	FY 2014 108,730	FY 2015 111,584	FY 2016 111,156	FY 2017 77,669

Table 20. Individuals with Intellectual Disability as a Primary Disability and an Employment Outcome by Age at Application: FY 2014 - FY 2017. Source: RSA-911
Note: FY 2017 includes cases that were closed between October 1, 2016 and June 30, 2017.

Individuals with Autism and an Employment Outcome by Gender
Gender	FY 2014	FY 2015	FY 2016	FY 2017
Gender Male	FY 2014 6,135	FY 2015 7,684	FY 2016 8,746	FY 2017 6,903
Gender Female	FY 2014 1,120	FY 2015 1,434	FY 2016 1,659	FY 2017 1,284

Table 21. Individuals with Autism as a Primary or Secondary Cause of Disability and an Employment Outcome by Gender: FY 2014 - FY 2017. Source: RSA-911
Note: FY 2017 includes cases that were closed between October 1, 2016 and June 30, 2017.

Individuals with Intellectual Disability and an Employment Outcome by Gender
Gender	FY 2014	FY 2015	FY 2016	FY 2017
Gender Male	FY 2014 64,579	FY 2015 66,262	FY 2016 66,628	FY 2017 46,173
Gender Female	FY 2014 44,151	FY 2015 45,321	FY 2016 44,528	FY 2017 31,496

Table 22. Individuals with Intellectual Disability as a Primary Disability and an Employment Outcome by Gender: FY 2014 - FY 2017. Source: RSA-911
Note: FY 2017 includes cases that were closed between October 1, 2016 and June 30, 2017.

Individuals with Autism and an Employment Outcome by Race
Race/Ethnicity	FY 2014	FY 2015	FY 2016	FY 2017
Race/Ethnicity White	FY 2014 6,435	FY 2015 8,060	FY 2016 9,055	FY 2017 7,076
Race/Ethnicity Black or African American	FY 2014 665	FY 2015 886	FY 2016 1,092	FY 2017 895
Race/Ethnicity American Indian or Alaska Native	FY 2014 101	FY 2015 120	FY 2016 167	FY 2017 98
Race/Ethnicity Asian	FY 2014 172	FY 2015 237	FY 2016 325	FY 2017 257
Race/Ethnicity Native Hawaiian or Other Pacific Islander	FY 2014 43	FY 2015 37	FY 2016 76	FY 2017 50
Race/Ethnicity Ethnicity – Hispanic or Latino	FY 2014 390	FY 2015 577	FY 2016 704	FY 2017 562

Table 23. Individuals with Autism as a Primary or Secondary Cause of Disability and an Employment Outcome by Race: FY 2014 - FY 2017. Source: RSA-911
Note: FY 2017 includes cases that were closed between October 1, 2016 and June 30, 2017.
Note: More than one race variable can be selected for an individual.

Individuals with Intellectual Disability and an Employment Outcome by Race
Race/Ethnicity	FY 2014	FY 2015	FY 2016	FY 2017
Race/Ethnicity White	FY 2014 80,015	FY 2015 82,060	FY 2016 81,231	FY 2017 57,104
Race/Ethnicity Black or African American	FY 2014 26,472	FY 2015 27,156	FY 2016 27,530	FY 2017 19,020
Race/Ethnicity American Indian or Alaska Native	FY 2014 2,263	FY 2015 2,441	FY 2016 2,330	FY 2017 1,498
Race/Ethnicity Asian	FY 2014 1,573	FY 2015 1,824	FY 2016 2,009	FY 2017 1,439
Race/Ethnicity Native Hawaiian or Other Pacific Islander	FY 2014 477	FY 2015 527	FY 2016 632	FY 2017 438
Race/Ethnicity Ethnicity – Hispanic or Latino	FY 2014 13,004	FY 2015 13,491	FY 2016 14,497	FY 2017 10,580

Table 24. Individuals with Intellectual Disability as the Primary Disability and an Employment Outcome by Race: FY 2014 - FY 2017. Source: RSA-911
Note: FY 2017 includes cases that were closed between October 1, 2016 and June 30, 2017.
Note: More than one race variable can be selected for an individual.

Health Resources and Services Administration

The HRSA Autism CARES Research Program funds research to support studies that advance the current knowledge base pertaining to ASD/DD and lead to improvements in interventions that address the health needs of children and adolescents with ASD/DD. Thirty-one studies conducted between October 2014 (FY 2014) and January 2018 (first quarter of FY 2018) are described below. Additional details on HRSA-funded studies can be found in Appendix iv.

Eight Autism Intervention Research Network on Behavioral Health (AIR-B) studies focus on the effectiveness and outcomes of behavioral interventions for children with ASD in school and community-based settings. For example, the Building Better Bridges randomized controlled trial study is testing an intervention to improve school transition outcomes for children with ASD and their families. Community partners, parents, teachers and school administrators have been consulted in the design of the intervention to ensure that the specific challenges faced by each group are addressed in the intervention. Parents who have already been through school transitions with a child on the autism spectrum are trained to implement the intervention with other parents who are currently managing school transitions.

The Autism Intervention Research Network on Physical Health (AIR-P) had 12 studies focusing on the effectiveness and outcomes of interventions for individuals diagnosed with ASD. One study tested an intervention to improve the physical health of individuals with ASD by developing a manualized wireless moisture alarm intervention for toilet training children with ASD. The intervention was successfully piloted in school settings. AIR-P is also investigating how a collaborative telehealth intervention using Extension for Community Healthcare Outcomes Autism technology may increase the provider knowledge, improve the clinical practice, and enhance the self-efficacy of providers in their care of children with ASD. Participating providers reported improved self-efficacy, increased adherence to ASD screening guidelines, and a positive influence on the quality of and access to healthcare for children with ASD. AIR-P also employed secondary data analyses to examine factors associated with ASD symptoms and diagnosis.

The Developmental-Behavioral Pediatrics Research Network (DBPNet) had three studies that will improve diagnosis and treatment of youth with ASD in developmental behavioral pediatrics clinical settings. One study focused on the feasibility of extracting electronic health records to examine the relationship between prescribed psychotropic medications and the physicians' diagnoses. The study found that there is large variation in prescription of psychotropic medication to children with ASD across three academic DBP program sites, and that for young children aged 3 to 5 with ASD, those with medical assistance were more likely to have medications prescribed than children with private insurance. However, this relationship is not true for older children with ASD.

Two DBPNet studies aim to determine whether the NIH Patient Reported Outcome Measurement Information System (PROMIS ®) measures, which are valid with the typically developing population, may be useful in assessing intervention effectiveness for children with ASD. The first study found that the PROMIS Pediatric Parent-Proxy Peer Relationships Measure (where the parents completed the measure about their children) may be an efficient, precise, and valid measure of peer relationships for 5- to 12-year-old children with ASD. Preliminary findings from the second study of PROMIS measures indicate that the peer relationships and stress experiences measures are reasonably valid when used in a population of youth, aged 12-17, with ASD who are literate at a third-grade reading level. Specifically, the peer relationships measure was highly correlated with another measure of social responsiveness, which is commonly used to measure autism severity.

The MCH Health Care Transitions Research Network for Youth and Young Adults with ASD (HCT-RN) implemented one study focused on this topic. This study consisted of a collaborative improvement network where pediatric residency training programs conduct rapid cycle improvement tests to refine and optimize the process of implementing the previously developed Health Care Transition Curriculum for Primary Care Residents. The specific results of the improvement process were published in a supplement to the Journal of Pediatrics, in April 2018.

Overall, seven Autism FIRST research projects focused on the effectiveness and outcomes of interventions for individuals diagnosed with ASD. Four of the Autism FIRST studies tested specific interventions for children with ASD across various environments such as the clinic, home, or school setting and at different age levels ranging from 2-12 years old. For example, one FIRST study used low dose sertraline (2.5 to 5.0mg/d) in children with ASD who are between 2 and 6 years old to improve language, behavior, and development issues. Three of the Autism SDAR Program studies covered a wide range of topics including developing an abbreviated scoring procedure for an ASD screener, determining out-of-pocket costs that families with ASD incur when using private health insurance, and adversities that families with ASD experience and their relationships to diagnosis and access to treatment.

Effectiveness and outcomes by severity level, age, or other demographic factors

HRSA supported 38 research studies that focused on how factors, such as severity level, age of child, and demographic characteristics may affect the effectiveness and outcomes of interventions for individuals diagnosed with ASD/DD. This includes eight Autism FIRST projects, nine AIR-B, thirteen AIR-P, five DBPNet, and three HW-RN studies.

Six of the Autism FIRST studies tested modified interventions that address barriers to intervention effectiveness with minimally verbal children, parental stress, racial/ethnic minorities, disadvantaged geographic location, and low income. For example, one FIRST study was effective in lowering stress level and improving caregiver skills, while also improving engagement, play frequency, and joint attention behaviors in toddlers. Two Autism SDAR studies identified barriers to early intervention such as measurement bias (i.e. age, gender, ethnic group) in diagnostic tools and the impact of adverse family experiences of underrepresented minorities on seeking services (i.e., children with ASD experience more adverse childhood experiences, including neighborhood violence, parental divorce, parental mental illness, and parental substance abuse). Research is addressing disparities in early identification of ASD and subsequent service utilization. One study demonstrated the effectiveness of an evidence-based screening program and evidence-based training protocols for primary care staff that was adapted for use with Latino families. This early screening intervention increased the rate of completion of the Modified Checklist for Autism in Toddlers (M-CHAT), a standardized developmental tool for eligible children ages 18 and 24 months, which increased from less than 5% prior to the onset of the intervention to approximately 60% after 3 months of implementation to nearly 100% at 6 months into the intervention.

Nine AIR-B studies focus on developing and testing the efficacy of behavioral interventions for children with ASD in school and community-based settings. Results from the multi-site, formative research phase of AIR-B's Mind the Gap study found that the best place to intervene was with families waiting to receive services. Informed by the formative research with parents and providers of low-income, minority children with ASD, the ongoing Mind the Gap intervention is a community-driven intervention for low-income parents and minority children with ASD that is low intensity, and likely to be both effective and sustainable resulting in increased access to care for under-resourced children.

AIR-P implemented thirteen research studies, which examined factors such as diagnosis and treatment of co-morbidities, to improve outcomes in individuals receiving treatment for ASD. One study found that a fixed dose of metformin can be effective for decreasing weight gain associated with atypical antipsychotic medication used to treat ASD in children and adolescents.

DBPNet's Project EARLY is a multi-site study that builds on evidence from a small pilot family navigation study to examine whether a family navigator can improve access to ASD diagnostic and treatment services, and improve outcomes for children who screen positive for ASD at pediatric primary care centers serving low-income communities. Approximately 255 racial and ethnic minority families from historically underserved communities have enrolled in the study and are receiving family navigation services.

Three studies by the Healthy Weight Research Network (HW-RN) are examining feeding and weight management in children and adolescents diagnosed with ASD. One study in particular is evaluating the impact, acceptability, and feasibility of a pilot adaptive weight management intervention for overweight children with ASD aged 4 to 8 years old.

Innovative and newly-developed intervention strategies

Ten Autism FIRST studies measure the effectiveness and outcomes of innovative and newly developed intervention strategies for individuals with ASD/DD. Seven of these studies conducted and tested innovative interventions across study settings, developmental stages, and subpopulations. The studies focused on a broad range of topics to include telehealth parent training, mindfulness training to enhance parent-coaching, and teacher-mediated toilet training using a manualized moisture alarm. One study examined a telehealth intervention that trained parents in implementing applied behavior analysis (ABA) to treat challenging behavior in young children with autism that demonstrated successful reduction of problem behavior similar to in-home therapy. The findings support the potential for using telehealth at significantly less cost than in-home therapy to provide research based behavioral treatment to families with limited access to providers such as in rural and geographically isolated communities.

Another FIRST study examining the effects of an adaptive intervention implemented by therapists and parents to improve communication outcomes for 3-4 year-old minimally-verbal children with ASD has been rated by parents as effective, worthwhile, and able to improve their competence as a language teacher for their child with ASD. Three of the autism SDAR studies developed and tested innovative approaches. One SDAR study created and measured a more effective and efficient Social Communication Questionnaire (SCQ) screening process.

HRSA's Autism Longitudinal Data Project is studying the association of maternal and cord blood metabolomes, placental histological findings, and in utero fetal growth patterns with ASD risk to improve early prediction and to test interventions. The Autism Transitions Research Project is conducting two innovative studies that will examine factors associated with healthy life outcomes among adolescents and young adults with ASD transitioning to adulthood.

Among the Research Networks, AIR-B has eight studies measuring the effectiveness of innovative strategies. One AIR-B study entitled, "Remaking Recess" was effective in increasing social engagement between school-aged children ages 5-11 years with autism and their peers during recess time. AIR-P has 14 studies covering a broad range of topics such as oral health for underserved children, physical exercise, sleep disturbance, resiliency, and the use of probiotics to improve GI health and emotional stability. DBPNet has three studies focused on this topic. In one study, DBPNet investigators are examining the role of family navigators to improve ASD diagnosis, treatment, and outcomes. HW-RN has six studies demonstrating innovation. Study topics include family-based weight loss treatment, physical activity among adolescents, and piloting an adaptive weight management intervention in 4-8 year-old children with ASD.

National Institutes of Health

The following NIH-funded projects provide information on the effectiveness and outcomes of interventions for those with ASD and other DD:

Predicting Treatment Outcomes in ASD: In a study of 6-year-old children diagnosed with ASD, NIMH-supported researchers using advanced brain imaging techniques found that specific neural patterns in response to certain visual stimuli were effective in predicting these children's response to behavioral treatments. Advancements in treatment prediction will enable researchers and clinicians to better identify and steer children to the most effective treatments and services specific to their needs and core deficits [PMID: 27845779].

Interventions to Improve Skills for Minimally Verbal Children with ASD: Focused on a sample of minimally-verbal children, for which effective interventions are very scarce, this study supported by NICHD randomly assigned children to the intervention with and without a speech-generating assistive device, as part of a 6-month behavioral intervention program. Children in both conditions saw significant improvements in the functional and symbolic play skills, indicating that minimally-verbal children respond to and benefit from intervention efforts [PMID: 29170936].

Improving Social Attention in ASD with a Parent-delivered Intervention: NICHD-supported researchers found that infants at increased risk for ASD (6-18 months of age) who received an innovative parent-delivered intervention program showed greater improvements in social attention and engagement than infants who did not receive any type of developmental intervention. The findings suggest that early parent-mediated intervention may have promising developmental impact on social and cognitive attention skills for children at very young ages [PMID: 28244271].

Interventions for Minimally Verbal Children with ASD: In this longitudinal study, NIMH researchers found that a combination of three intervention approaches (Joint Attention, Symbolic Play, Enhanced Milieu Teaching, and a Speech-Generating Device), led to the greatest gains in spontaneous communication utterances and joint attention among minimally-verbal children with ASD [PMID: 26954267].

Autism Dissemination Education to Hispanic Community: Low income Hispanic families experience multiple barriers to accessing evidence-based information on ASD. This NIMH-funded study utilized a mixed-strategy intervention to create access to information in published biomedical research articles on ASD by distilling the content into parent-friendly English- and Spanish-language ASD Science Briefs and presenting them to participants using two socially-oriented dissemination methods. There was a main effect for short-term knowledge gains associated with the Science Briefs but no effect for the dissemination method. After 5 months, participants reported utilizing the information learned and 90% requested greater access to Science Briefs. These findings highlight the benefits of distilling biomedical research articles on ASD into parentfriendly educational products for currently underserved Hispanic parents [PMID: 26563948].

Transition Supports for College-age Students with ASD: Based on pilot research supported by NIMH, the Stepped Transition in Education Program for Students with ASD (STEPS) was developed to support students with ASD transitioning to college. Level One supports high school students and Level Two is for postsecondary students. The impact of STEPS on promotion of successful transition into college and positive outcomes for students during higher education is currently being evaluated in a randomized controlled trial [PMID: 28685409].

Intervention Therapies for Minimally Verbal Children with ASD: Researchers supported by an NIDCD Autism Centers of Excellence grant at Boston University focused on minimally verbal individuals with ASD and proposed an innovative intonation-based intervention. They published findings of an intervention trial where children provided with auditory mapping motor training showed significantly greater advances in producing more syllables and consonants than children given speech repetition therapy. Results from this intervention trial offer a promising new interventional approach for teaching spoken language to minimally-verbal children with ASD [PMID: 28928645].

Healthcare Assessment Tool for Individuals with ASD: An NIMH-supported study gathered data from adults with ASD and primary care providers (PCPs) to develop and evaluate tools to facilitate the primary health care of adults with ASD. The Autism Healthcare Accommodations Tool allows patients to create a personalized report that includes general health care and autism-related information and other resources for use by the PCP and patient. Preliminary results indicated that the tool positively impacted health care interactions between patients with autism and their providers [PMID: 27271730].

Virtual-reality Job Interview Tools for Individuals with ASD: Four RCTs funded by NIMH revealed that virtualreality job interview training improved interviewing skills and the odds of obtaining a job offer among trainees with severe mental illness or ASD [PMID: 28292223].