NCT06552286

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Jul 2024Dec 2029

Study Start

First participant enrolled

July 10, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

5.5 years

First QC Date

August 1, 2024

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adaptive Behavior Assessment System, Third Edition

    4 months

Study Arms (2)

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

EXPERIMENTAL

randomized to STRW-T intervention

Behavioral: STRW-T

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

ACTIVE COMPARATOR

randomized to PEERS-T intervention

Behavioral: PEERS-T

Interventions

STRW-TBEHAVIORAL

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).

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

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.

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

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of North Carolina - Chapel Hill

Carrboro, North Carolina, 27510, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Amie Duncan, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amie Duncan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Coordinator who is assessing goals of participants is masked from knowing which group each participant was randomized to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial - A study in which the participants are divided by chance into separate groups that compare different treatments or other interventions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 13, 2024

Study Start

July 10, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations