Strengthening Skills Behavioral Intervention for Adults With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04802434
• Other study ID #: 00011585
• Secondary ID: W81XWH-20-1-0171
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: November 2023
• Source: Southwest Autism Research & Resource Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Southwest Autism Research & Resource Center	Arizona State University, Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Mean Change from Baseline in Prospective Memory on the Royal Prince Alfred Prospective Memory Test	4-item behavioral measure of prospective memory. Each item has a maximum score of three points, with a total possible score of 12 points. Scores range from 0 to 12, with higher scores indicating better prospective memory.	Post-Intervention (16 weeks)