Clinical trial NCT04802434: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Southwest Autism Research & Resource Center
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: Mayo Clinic
First posted: 2021-03-17
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Change from Baseline in Adaptive Functioning on the Adaptive Behavior Assessment System, Third Edition (ABAS-3)
timeFrame: Post-Intervention (16 weeks); 3-month follow-up; 6-month follow-up
measure: Mean Change from Baseline in Self-reported Quality of Life on the World Health Organization's Brief Quality of Life assessment (WHOQOL-BREF)
timeFrame: Post-Intervention (16 weeks); 3-month follow-up; 6-month follow-up
Secondary outcomes:
measure: Mean Change from Baseline in Prospective Memory on the Royal Prince Alfred Prospective Memory Test
timeFrame: Post-Intervention (16 weeks)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Southwest Autism Research & Resource Center
name: Nicole L Matthews, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona State University
name: Brittany B Braden, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: