Strengthening Skills Behavioral Intervention for Adults With Autism Spectrum Disorder

Sponsor

Southwest Autism Research & Resource Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04802434

Collaborator

Arizona State University (Other), Mayo Clinic (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Behavioral: Strengthening Skills Program Behavioral: PEERS Social Skills Program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Trial of Strengthening Skills, A Multi-Component Behavioral Intervention to Increase Functional Independence During Aging in Autism Spectrum Disorder

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Strengthening Skills Program 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 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. Behavioral: PEERS Social Skills Program 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.
Active Comparator: PEERS Social Skills Program 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 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.
No Intervention: Delayed Treatment Control Group 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).

Arm

Intervention/Treatment

Experimental: Strengthening Skills Program

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

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.

Behavioral: PEERS Social Skills Program

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.

Active Comparator: PEERS Social Skills Program

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

No Intervention: Delayed Treatment Control Group

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).

Outcome Measures

Primary Outcome Measures

Mean Change from Baseline in Adaptive Functioning on the Adaptive Behavior Assessment System, Third Edition (ABAS-3) [Post-Intervention (16 weeks); 3-month follow-up; 6-month follow-up]
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).
Mean Change from Baseline in Self-reported Quality of Life on the WHOQOL-BREF [Post-Intervention (16 weeks); 3-month follow-up; 6-month follow-up]
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 four quality of life domain scores: physical health, psychological, social relationships, and environment.

Secondary Outcome Measures

Mean Change from Baseline in Prospective Memory on the Royal Prince Alfred Prospective Memory Test [Post-Intervention (16 weeks)]
4-item behavioral measure of prospective memory. Each item has a maximum score of three points, with a total possible score of 12 points.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Southwest Autism Research & Resource Center
Arizona State University
Mayo Clinic

Investigators

Principal Investigator: Nicole L Matthews, Ph.D., Southwest Autism Research & Resource Center
Principal Investigator: Brittany B Braden, Ph.D., Arizona State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nicole Matthews, Ph.D., Research Scientist, Southwest Autism Research & Resource Center

ClinicalTrials.gov Identifier:

NCT04802434

Other Study ID Numbers:

00011585
W81XWH-20-1-0171

First Posted:

Mar 17, 2021

Last Update Posted:

Mar 17, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Autistic Disorder

Autism Spectrum Disorder

Child Development Disorders, Pervasive

Study Results

No Results Posted as of Mar 17, 2021