Strengthening Skills Behavioral Intervention for Adults With Autism Spectrum Disorder

NCT ID: NCT04802434

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Strengthening Skills Program

Intervention Type 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.

PEERS Social Skills Program

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

PEERS Social Skills Program

Intervention Type 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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arizona State University

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Southwest Autism Research & Resource Center

OTHER

Sponsor Role lead

Responsible Party

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Nicole Matthews, Ph.D.

Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicole L Matthews, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Southwest Autism Research & Resource Center

Brittany B Braden, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

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Arizona State University

Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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W81XWH-20-1-0171

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

00011585

Identifier Type: -

Identifier Source: org_study_id