Autism Spectrum DisorderNCT04802434

Strengthening Skills Behavioral Intervention for Adults With Autism Spectrum Disorder

A study testing Strengthening Skills Program and PEERS Social Skills Program in people with Autism Spectrum Disorder, run by Southwest Autism Research & Resource Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 70 years
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: Strengthening Skills Program and PEERS Social Skills Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2021to 30 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Arizona State University
Tempe, Arizona, 85281

Other trials in United States

About this study

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

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
Being tested: Strengthening Skills Program, PEERS Social Skills Program
Medical subject headings: Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Strengthening Skills ProgramBehavioural
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 ProgramBehavioural
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.

Study groups in NCT04802434
Study group	Role	What they receive
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. Receives: 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. Receives: 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
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.
Measured: Post-Intervention (16 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202130 Apr 2023

First posted17 Mar 2021
Study start1 Apr 2021
Primary completion30 Apr 2023
Study completion30 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04802434
Sponsor's protocol ID: 00011585
Other IDs: W81XWH-20-1-0171
Status last verified: Nov 2023
First submitted: 12 Mar 2021
Last updated: 22 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All individual participant data (IPD) that underlie results in a publication will be available upon request to approved researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Strengthening Skills, A Multi-Component Behavioral Intervention to Increase Functional Independence During Aging in Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT04802434
Acronym / sponsor ID: 00011585
Conditions: Autism Spectrum Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Southwest Autism Research & Resource CenterUniversity, hospital or other
Collaborators: Arizona State University, Mayo Clinic
Study start: 1 Apr 2021 (actual)
Primary completion: 30 Apr 2023 (actual)
Study completion: 30 Apr 2023 (actual)
First posted: 17 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Strengthening Skills Program	Experimental	Behavioral: Strengthening Skills Program, Behavioral: PEERS Social Skills ProgramAdults 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.
PEERS Social Skills Program	Active comparator	Behavioral: PEERS Social Skills ProgramAdults 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.
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).

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Strengthening Skills ProgramThe 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.	Behavioural	Strengthening Skills Program
PEERS Social Skills ProgramPEERS® 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.	Behavioural	PEERS Social Skills Program, Strengthening Skills Program

Primary outcome

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

1 secondary outcome

Mean Change from Baseline in Prospective Memory on the Royal Prince Alfred Prospective Memory Test
Time frame: Post-Intervention (16 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in a publication will be available upon request to approved researchers.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicole L Matthews, Ph.D. principal investigator

Southwest Autism Research & Resource Center

Brittany B Braden, Ph.D. principal investigator

Arizona State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Strengthening Skills Program and PEERS Social Skills Program in people with Autism Spectrum Disorder, run by Southwest Autism Research & Resource Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change from Baseline in Adaptive Functioning on the Adaptive Behavior Assessment System, Third Edition (ABAS-3) (time frame: Post-Intervention (16 weeks); 3-month follow-up; 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04802434.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.