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Strengthening Skills Behavioral Intervention for Adults With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strengthening Skills Program
PEERS Social Skills Program
Sponsored by
Southwest Autism Research & Resource Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Strengthening Skills Program

PEERS Social Skills Program

Delayed Treatment Control Group

Arm Description

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.

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.

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 12, 2021
Last Updated
October 3, 2022
Sponsor
Southwest Autism Research & Resource Center
Collaborators
Arizona State University, Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04802434
Brief Title
Strengthening Skills Behavioral Intervention for Adults With Autism Spectrum Disorder
Official Title
Randomized Controlled Trial of Strengthening Skills, A Multi-Component Behavioral Intervention to Increase Functional Independence During Aging in Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Autism Research & Resource Center
Collaborators
Arizona State University, Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strengthening Skills Program
Arm Type
Experimental
Arm Description
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.
Arm Title
PEERS Social Skills Program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Delayed Treatment Control Group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Strengthening Skills Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PEERS Social Skills Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change from Baseline in Adaptive Functioning on the Adaptive Behavior Assessment System, Third Edition (ABAS-3)
Description
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.
Time Frame
Post-Intervention (16 weeks); 3-month follow-up; 6-month follow-up
Title
Mean Change from Baseline in Self-reported Quality of Life on the World Health Organization's Brief Quality of Life assessment (WHOQOL-BREF)
Description
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.
Time Frame
Post-Intervention (16 weeks); 3-month follow-up; 6-month follow-up
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in Prospective Memory on the Royal Prince Alfred Prospective Memory Test
Description
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.
Time Frame
Post-Intervention (16 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole L Matthews, Ph.D.
Organizational Affiliation
Southwest Autism Research & Resource Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brittany B Braden, Ph.D.
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data (IPD) that underlie results in a publication will be available upon request to approved researchers.
IPD Sharing Time Frame
Data will be available upon request starting 6 months after publication and will remain available for 2 years.
IPD Sharing 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.

Learn more about this trial

Strengthening Skills Behavioral Intervention for Adults With Autism Spectrum Disorder

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