Strengthening Skills Behavioral Intervention for Adults With Autism Spectrum Disorder

NCT04802434 | Completed

• 2 other identifiers: 00011585W81XWH-20-1-0171
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine changes in adaptive functioning, quality of life, and prospective memory among adults with ASD (Autism Spectrum Disorder) who complete Strengthening Skills, a multi-faceted, behavioral intervention that combines the PEERS Social Skills program with cognitive compensation training, mindfulness-based emotional regulation, and support group components. Participants and their study partners (e.g., spouse, parent, friend) will be randomly assigned to one of three groups: Strengthening Skills, PEERS only, or a delayed treatment control group. The Strengthening Skills group will meet weekly for 3 hours for 16 weeks and will learn strategies for gaining and maintaining independence and emotion regulation. Participants will also learn strategies from the PEERS Social Skills Program. The PEERS only group will meet weekly for 1.5 hours for 16 weeks and will only learn strategies from the PEERS Social Skills Program. The delayed treatment control group will participant in data collection at four time points over a 10-month wait period, after which, they will be enrolled into the Strengthening Skills Program. Behavioral self-report data will be collected and a prospective memory assessment will be conducted before and after participation in the 16-week programs. Behavioral self-report data will also be collected at remote 3- and 6-month follow-up visits.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Mean Change from Baseline in Adaptive Functioning on the Adaptive Behavior Assessment System, Third Edition (ABAS-3)

  The ABAS-3 Adult Form is a self and other-report questionnaire designed specifically for adult participants (ages 16 to 89), which yields standard scores (Mean = 100, Standard Deviation = 15) in three adaptive domains (i.e., Conceptual, Social, and Practical) and a General Adaptive Composite (GAC). Scores range from 40 to 120 with higher scores indicating better adaptive functioning.

  Post-Intervention (16 weeks); 3-month follow-up; 6-month follow-up

• Mean Change from Baseline in Self-reported Quality of Life on the World Health Organization's Brief Quality of Life assessment (WHOQOL-BREF)

  The WHOQOL-BREF is an abbreviated version of the World Health Organization's Quality of Life assessment (WHOQOL-100). 26-item self-report questionnaire that yields an Overall Quality of Life and General Health score and four quality of life domain scores: physical health, psychological, social relationships, and environment. Scores range from 0 to 100 on all domains, with higher scores indicating better quality of life.

  Post-Intervention (16 weeks); 3-month follow-up; 6-month follow-up

Secondary Outcomes (1)

• Mean Change from Baseline in Prospective Memory on the Royal Prince Alfred Prospective Memory Test

  Post-Intervention (16 weeks)

Study Arms (3)

Strengthening Skills Program

EXPERIMENTAL

Adults with ASD and their study partners (i.e., spouse, parent, other family member, or friend) will attend weekly 3 hour meetings for 16 weeks, during which, behavioral intervention strategies will be used to teach cognitive compensation and mindfulness-based emotion regulation skills. Strategies from the PEERS Social Skills Program will also be taught. Participants will be assigned homework assignments each week to practice skills they are learning in a real-world setting.

Behavioral: Strengthening Skills Program; Behavioral: PEERS Social Skills Program

PEERS Social Skills Program

ACTIVE COMPARATOR

Adults with ASD and their study partners (i.e., spouse, parent, other family member or friend) will attend weekly 1.5 hour meetings for 16 weeks, during which, behavioral intervention strategies will be used to teach skills for improving social relationships and handling social rejection. Participants will be assigned homework assignments each week to practice skills they are learning in a real-world setting.

Behavioral: PEERS Social Skills Program

Delayed Treatment Control Group

NO INTERVENTION

Participants in the delayed treatment control group will participate in a 10-month wait period, during which they will complete data collection procedures at three time points (Baseline, Post, and 6-month follow-up).

Interventions

Strengthening Skills Program BEHAVIORAL

The Strengthening Skills Program is a new, multi-component intervention. It includes three components: (1) Forming habits to compensate for the difficulties many adults with ASD have with thinking flexibly, planning, and time management. It will emphasize habit-forming behaviors to compensate for weaknesses in functional skills by training on practical techniques; (2) Content from the PEERS Social Skills program to target social challenges, and (3) strategies derived from Mindfulness Based Stress Reduction to target emotion regulation.

Strengthening Skills Program

PEERS Social Skills Program BEHAVIORAL

PEERS® is a well-established social communication training program, initially developed for adolescents, and more recently extended to young adults with ASD. Program content will be adapted slightly so as to be appropriate for older adults.

PEERS Social Skills Program; Strengthening Skills Program

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets criteria for autism or autism spectrum on a gold-standard diagnostic assessment (Autism Diagnostic Observation Schedule-2)
• Must have a study partner (e.g., parent, spouse, sibling, friend) willing and able to complete questionnaires at all four time points
• Must be willing to be randomized to a treatment or delayed treatment control group
• Must be able to attend at least 14 of the 16 weekly intervention sessions
• English speaking: Participants must be English-speaking because the screening and behavioral measures are in English (including the intelligence estimate), as well as the intervention content

You may not qualify if:

• Non-verbal participants will be excluded to ensure test compliance and increase sample homogeneity.
• Participants with IQ (intelligence quotient) scores lower than 70 will be excluded because the interventions were developed for individuals without intellectual disability.

Sponsors & Collaborators

• Southwest Autism Research & Resource Center: lead
• Arizona State University: collaborator
• Mayo Clinic: collaborator

Study Sites (1)

Arizona State University

Tempe, Arizona, 85281, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nicole L Matthews, Ph.D.

  Southwest Autism Research & Resource Center

  PRINCIPAL INVESTIGATOR

• Brittany B Braden, Ph.D.

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: April 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available upon request starting 6 months after publication and will remain available for 2 years.
• Access Criteria: Data requests should be submitted to Dr. Blair Braden at bbbraden@asu.edu and must include study aims and purpose and a detailed analysis plan describing how the data will be used. Requests will be reviewed by Dr. Braden and access to the data will be made available through a secure link to download the requested data.

Locations

US (1)