STRW-T Intervention for Autistic Adolescents in 11th and 12th Grade (STRW-T)

A Multisite RCT of a Daily Living Skills Intervention for Autistic Adolescents Prior to the Transition to Adulthood

The current study seeks to compare outcomes of a telehealth intervention targeting daily living skills (Surviving and Thriving in the Real World - Telehealth, or STRW-T) intervention to a control group telehealth intervention targeting social skills (Program for the Education and Enrichment of Relational Skills- Telehealth, or PEERS-T). The key endpoint will be change in daily living skills on primary and secondary outcome measures at the end of treatment.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: STRW-T; Behavioral: PEERS-T

Detailed Description

Individuals with high functioning autism spectrum disorder (ASD) are not developing the skills necessary to successfully transition from adolescence to college, employment, and independent living.

Daily living skills (DLS) have been linked to positive adult outcome in individuals with ASD.

Despite the importance of daily living skills to adult outcome, adolescents with high functioning ASD have impaired daily living skills.

A complex set of environmental, individual, and family factors likely affect the ability of adolescents with high functioning ASD to acquire critical daily living skills.

There are currently no evidence-based daily living skills intervention packages for adolescents with high functioning ASD that would prepare them for independence in adulthood.

A total of 192 autistic adolescents between the ages of 15-21 who are in their last 2 years of high school will be randomized to the STRW-T group (n=96) or the PEERS-T control group (n=96). Outcome measures will be assessed at baseline, post-treatment, 6-month follow-up, and 6-month post-high school graduation assessments. Adolescents will meet the following inclusion criteria: (1) a diagnosis of ASD; (2) enrolled in 11th or 12th grade; (3) Intelligence Quotient of greater than or equal to 70; and (4) a DLS deficit on the Vineland-3 interview as reported by caregivers.

Aim 1: Examine the efficacy of STRW-T on DLS compared to a control group (PEERS-T). Hypothesis 1: STRW-T youth will have greater gains on the primary DLS assessment (VABS-3) compared to PEERS-T youth at post-treatment; Hypothesis 2: STRW-T youth will have greater gains on secondary DLS assessments (Adaptive Behavior Assessment System, 3rd Edition, DLS-Goal Attainment Scale, daily phone diaries) compared to PEERS-T at post-treatment.

Aim 2: Evaluate whether the improvement on DLS outcomes by STRW-T are sustained beyond the intervention period. Hypothesis 3: The impact of STRW-T on DLS gains (as assessed by primary and secondary DLS assessments) will be sustained at 6-months post-treatment.

Aim 3: Examine the effects of the STRW-T intervention on outcomes in college, employment, and Quality of Life after high school graduation. Hypothesis 4: STRW-T youth will have better college, employment, and Quality of Life outcomes compared to PEERS-T youth at 6-months post-high school graduation.

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carrie Fassler; Phone Number: 5138033580; Email: carrie.fassler@cchmc.org
• Study Contact Backup: Name: Amie Duncan, PhD; Email: amie.duncan@cchmc.org

Study Locations

• United States
  • North Carolina
    • Carrboro, North Carolina, United States, 27510
      • Recruiting
      • University of North Carolina - Chapel Hill
      • Contact: Laura Klinger, Ph.D.; Email: laura_klinger@med.unc.edu
      • Principal Investigator: Laura Klinger, Ph.D.
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Carrie Fassler; Phone Number: 5138033580; Email: carrie.fassler@cchmc.org
      • Principal Investigator: Amie M Duncan, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• in the last 2 years of high school, or deferring graduation
• diagnosis of ASD based on clinical judgement and/or meeting the cut-off score on the Autism Diagnostic Observation Schedule, 2nd Edition
• full scale IQ of 70 or above as measured by the Wechsler Abbreviated Scale of Intelligence, 2nd Edition
• deficient Daily Living Skills as assessed by the Vineland Adaptive Behavior Scales, 3rd Edition - at least 1 of the 3 Daily Living Skills subdomains is at least 15 points below their full scale IQ

Exclusion Criteria:

• significant aggressive behaviors or mental health issues that require treatment out of the scope of the current intervention.
• if the adolescent has already completed the social skills group (PEERS), either at Cincinnati Children's or in another setting, unless it has been a significant amount of time since they did the PEERS group (2-3 years, or up to the discretion of the PI).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surviving and Thriving in the Real World - Telehealth (STRW-T); randomized to STRW-T intervention	Behavioral: STRW-T; The STRW-T intervention consists of 15 weekly caregiver group sessions and caregiver-teen dyad sessions delivered via Zoom. The targeted daily living skills (DLS) have been identified and refined through our prior studies and include: Morning routine, laundry, kitchen/cooking, grocery shopping, and money management. Evidence-based strategies are utilized to facilitate acquisition, mastery, and generalization of specific DLS at home and in the community. During dyad sessions, teens will work on DLS in their home environment and will receive coaching and instruction from both their caregiver and the therapist. During caregiver group sessions, the therapist will discuss the content of dyad sessions and engage in problem solving with each caregiver (e.g., using and fading rewards, implementing strategies to increase success, teen motivation/buy-in).
Active Comparator: Program for the Education and Enrichment of Relational Skills - Telehealth (PEERS-T); randomized to PEERS-T intervention	Behavioral: PEERS-T; PEERS-T is a 15-week intervention with concurrent caregiver and teen group telehealth sessions that target social skills (e.g., building friendships, conversing, dealing with bullying). PEERS-T was chosen as the control because it is one of the few evidence-based interventions for autistic adolescents and does not address daily living skills. PEERS-T is also matched to STRW-T on duration and is clinically meaningful to families.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vineland Adaptive Behavior Scales, 3rd Edition	The VABS-3 is a well-established standardized measure of adaptive behavior that assesses skills in the Communication, Daily Living Skills, and Socialization domains. The DLS domain is comprised of the Personal, Domestic, and Community subdomains and has items that directly correspond to goals being targeted in the STRW intervention. Subdomain v-scale scores: 1 to 24. Domain and Adaptive Behavior Composite Standard Scores: 20 to 140. The higher the score, the better the adaptive level. V-scale scores have a mean of 15 and standard deviation (SD) of 3. Standard scores have a mean of 100 and SD of 15.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adaptive Behavior Assessment System, Third Edition	The ABAS-3 Adult Other measure is a respondent report measure that assesses adaptive behavior in the conceptual, practical, and social domains. The Practical domain standard score summarizes performance across the Community Use, School Living, Health and Safety, and Self-Care skill areas. The standard score is calculated based on the sum of scaled scores for each of the skill areas. Scaled scores range from 1 to 19, with the average score being between 8-12. The standard scores typically range from 40 to 120, with a mean of 100 and a standard deviation of 15. Higher scores equate to better adaptive skills.	4 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Amie Duncan, PhD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: CIN-DUNCAN-2023-0476; 1R01HD113529-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No