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

NCT03984513 | Completed Results DMC

• 2 other identifiers: CIN-DUNCAN-2018-56061K23HD094855-01A1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Vineland Adaptive Behavior Scales, 3rd Edition

  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.

  At Baseline, at Post-Group (approx. 3 months)

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

Surviving and Thriving in the Real World BEHAVIORAL

The Surviving and Thriving in the Real World intervention consists of 14 weekly concurrent adolescent and parent group sessions. The daily living skills 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 daily living skills 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

Program for the Education and Enrichment of Relational Skills BEHAVIORAL

Program for the Education and Enrichment of Relational Skills 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 a get-together with other teens. Parents learn how to coach their teens to continue to use the skills when the program is complete.

PEERS

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• attending high school
• a diagnosis of autism spectrum disorder (ASD) (based on meeting the cut-off score on the Autism Diagnostic Observation Schedule, 2nd Edition.
• a full scale Intelligence Quotient (IQ) of 70 or above as measured by the Stanford Binet Intelligence Scales, 5th Edition.
• deficient daily living skills as assessed by the Vineland-3.

You may not qualify if:

• psychosis or other major psychiatric disorder requiring intensive treatment
• 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).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

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, Pervasive; Neurodevelopmental Disorders; Mental 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

Amie.Duncan@cchmc.org

513-803-2416

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 is masked from knowing which group each participant was randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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.

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 13, 2019
• Study Start: September 25, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: June 27, 2023
• Results First Posted: June 27, 2023

Record last verified: 2023-06

Locations

US (1)