NCT03984487

Brief Summary

The main objective of the current proposal is to conduct a pilot RCT (i.e., treatment group and social skills control group) to examine how participation in Surviving and Thriving in the Real World (STRW) Intervention affects proximal outcomes with a larger sample size (n = 72). As social skills, executive functioning, and parenting factors have been linked to the acquisition of Daily Living Skills (DLS), the current study will also explore how these are linked to participation in STRW. Lastly, goal attainment scaling (GAS) will be utilized, along with gold standard parent report and adolescent self-report measures, to assess DLS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 17, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 24, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 23, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

4.1 years

First QC Date

May 24, 2019

Results QC Date

May 31, 2023

Last Update Submit

July 21, 2024

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 Daily Living Skills domain is comprised of the Personal, Domestic, and Community subdomains and has items that directly correspond to goals being targeted in the STRW intervention. We are reporting the average (mean) Daily Living Skills Domain Raw Scores, both at baseline at post-treatment. The range for total raw score for the entire domain is 0 to 286. The higher the score, the more independent they are at overall daily living skills.

    4 months (from baseline to post-intervention)

Study Arms (2)

STRW

EXPERIMENTAL

Participants will receive the daily living skills intervention, Surviving and Thriving in the Real World (STRW).

Behavioral: Surviving and Thriving in the Real World

PEERS

ACTIVE COMPARATOR

Participants will receive a social skills intervention, Program for the Education and Enrichment of Relational Skills (PEERS).

Behavioral: Program for the Education and Enrichment of Relational Skills

Interventions

The STRW intervention consists of 14 weekly concurrent adolescent and parent group sessions. The DLS to be targeted in the intervention include: Morning Routine (i.e., completing a morning personal hygiene routine); Laundry (i.e., sorting clothing, using a washing machine and dryer, and folding and putting clothes away); Kitchen/Cooking (i.e., cooking items in the microwave, oven, and stove, safe kitchen practices, cleaning up the kitchen after cooking, and grocery shopping); Self-Management (i.e., managing worry and stress related to learning DLS and transitioning to adulthood); and Money Management (i.e., using money to purchase items, evaluating the quality and price of items, understanding and using a checking and savings account, and budgeting money to cover expenses).

STRW

PEERS is an evidence-based social skills training program for youth with social challenges between the ages of 13-18.The program includes a teen group and a parent group that meet concurrently. Teens learn about conversations, electronic communication, joining groups, humor, handling teasing and disagreements, and planning get-togethers with other teens. Parents learn how to coach their teens to continue to use the skills when the program is complete.

PEERS

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • in the last 2 years of high school
  • 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 Stanford Binet Intelligence Scales, 5th 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 (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Limitations and Caveats

Limitations of the current study include use of a caregiver report measure for the primary outcome, a relatively small sample size, and the need for a more diverse sample of autistic teens.

Results Point of Contact

Title
Dr. Amie Duncan
Organization
Cincinnati Children's Hospital

Study Officials

  • Amie M Duncan, Ph.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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 id 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

May 24, 2019

First Posted

June 13, 2019

Study Start

May 17, 2018

Primary Completion

June 30, 2022

Study Completion

August 31, 2023

Last Updated

July 23, 2024

Results First Posted

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations