NCT03984513

Daily Living Skills Intervention for 9th and 10th Graders With Autism Spectrum Disorders

Completed NA Results posted Last updated 27 June 2023

What this trial tests

NA trial testing Surviving and Thriving in the Real World in Autism Spectrum Disorder in 58 participants. Completed in 28 February 2022.

Timeline

25 September 2018

Primary endpoint
28 February 2022

28 February 2022

Quick facts

Lead sponsor	Children's Hospital Medical Center, Cincinnati
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	58
Start date	25 September 2018
Primary completion	28 February 2022
Estimated completion	28 February 2022
Sites	1 location across United States

Drugs / interventions tested

• Surviving and Thriving in the Real World
• Program for the Education and Enrichment of Relational Skills

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Adults 14 to 21, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Vineland Adaptive Behavior Scales, 3rd Edition Primary · At Baseline, at Post-Group (approx. 3 months)

The Vineland Adaptive Behavior Scales, 3rd Edition (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. If you add the total points possible for each subdomain, the total Daily Living Skills Domain raw scores can range from 0 to 286. The higher the score, the better the adaptive level.

Daily Living Skill Domain Raw Score at Baseline

Group	Value	95% CI
STRW	199.0	± 6.1
PEERS	177.9	± 5.4

Daily Living Skill Domain Raw Score at Post Group

Group	Value	95% CI
STRW	228.8	± 7.1
PEERS	203.3	± 6.4

Sponsor's own description

The current study seeks to develop the first daily living skills (DLS) intervention package for high functioning adolescents with autism spectrum disorder (ASD) and evaluate its effectiveness. The investigators hope to further refine the Surviving and Thriving in the Real World (STRW) intervention by conducting an ORBIT (Obesity-Related Behavioral Intervention Trial) Phase 2b feasibility Randomized Clinical Trial (RCT). This randomized clinical trial will test the preliminary effectiveness of STRW in 56 adolescents (14-21 years) with high functioning ASD as compared to a robust evidence-based social skills intervention (Program for the Evaluation and Enrichment of Relational Skills - PEERS). The current proposal represents a critical step toward improving the adult outcome of individuals with autism.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Closing the Gap: A Randomized Trial Targeting Daily Living Skills in Autistic Adolescents.
   Duncan A, Meinzen-Derr J, Ruble L, Fassler C, et al · · 2025 · PMID 40776988 · DOI 10.1177/10883576251355188
2. The role of family quality of life in the caregivers of autistic adolescents receiving treatment for daily living skills.
   Duncan A, Tadevich L. · · 2025 · PMID 40717833 · DOI 10.1016/j.reia.2025.202660