Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06552286

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
192 (estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati · Academic / Other
Sex
All
Age
15 Years – 21 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSTRW-TThe 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).
BEHAVIORALPEERS-TPEERS-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.

Timeline

Start date
2024-07-10
Primary completion
2029-12-31
Completion
2029-12-31
First posted
2024-08-13
Last updated
2026-03-18

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06552286. Inclusion in this directory is not an endorsement.