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

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: STRW-T; Behavioral: PEERS-T

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06552286

1R01HD113529-01 (U.S. NIH Grant/Contract)

CIN-DUNCAN-2023-0476

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 estimated patients

Sex: All

Ages: 15 to 21 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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192 participants in 2 patient groups

Surviving and Thriving in the Real World - Telehealth (STRW-T)

Experimental group

Description:

randomized to STRW-T intervention

Treatment:

Behavioral: STRW-T

Program for the Education and Enrichment of Relational Skills - Telehealth (PEERS-T)

Active Comparator group

Description:

randomized to PEERS-T intervention

Treatment:

Behavioral: PEERS-T