Adapting BA for Minimally Verbal Autistic Adults

March 20, 2024 updated by: Vanessa H. Bal, PhD, Rutgers, The State University of New Jersey

Adaptation of a Behavioral Activation Treatment to Treat Depression in Autistic Adults

The present study aims to adapt and evaluate the feasibility of the BeatIt-2 behavioral activation intervention for people with intellectual disabilities and low mood to be implemented with minimally verbal autistic individuals.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim 1. The first phase of the project will focus on adapting the BeatIt-2 manual to consider specific needs of MV autistic adults. This procedure includes an intervention development group (IDG), for which MV autistic adults and their supporters (i.e., someone identified as a source of support they can work with) will be recruited. Aim 2. During the following phase of the project, a feasibility trial will be conducted. Using the treatment manual and study procedures adapted and refined in phase 1, the trial will examine the feasibility and acceptability of BeatIt-MV.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Minimally verbal
  • Aged 18 years or older
  • Diagnosis of Autism Spectrum Disorder and clinically significant depression based on clinical best estimate diagnosis using DSM-5 or Diagnostic Manual - Intellectual Disability criteria
  • Have a support person willing to participate
  • Live in New Jersey or New York, or be within travel distance to Rutgers University

Exclusion Criteria:

  • Not able to engage in treatment in English
  • current engagement in other treatment for depression
  • conditions that may preclude engagement in treatment sessions (e.g., active psychosis, unmanaged seizures)
  • high suicide risk (i.e., with a clear plan, expressed intent or recent documented attempts)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BeatIt-MV Treatment Group
Participants, along with support persons, will complete 12 weekly sessions of the BeatIt-MV intervention. The support person will complete an initial session before commencement of the 12 weekly sessions.
Behavioral: BeatIt-MV
BeatIt-MV, designed to be implemented with minimally verbal autistic individuals, is an adaptation of BeatIt-2. The intervention aims to improve mood and decrease depressive symptoms through an increase in meaningful engagement in recreational, domestic, and social/leisure activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glasgow Depression Scale for Intellectual Disability (GDS)
Time Frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The GDS is a 20-item self- and caregiver-reported questionnaire of psychological function over the past week with all items on a "0" (Never/No) to 2 (Always/A lot) scale. Higher scores equal more distress. Scores range from 0-32. The expected change is a decrease in the score.
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Anxiety Depression and Mood Scale (ADAMS)
Time Frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The ADAMS is a 20-item caregiver-reported questionnaire of psychological function over the past week with all items on a "0" (Never/No) to 2 (Always/A lot) scale. Higher scores equal more distress. Total scores range from 0-84. The expected change is a decrease in the score.
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Mood, Interest, & Pleasure Questionnaire (MIPQ)
Time Frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The MIPQ is a 25-item caregiver-reported questionnaire of behaviors over the past week with all items on a "0" (Never) to 4 (All the time) scale. Higher scores equal more distress. Total scores range from 0-100. The expected change is a decrease in the score.
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)
Time Frame: Week 1 (initial assessment) to week 22 (follow-up)
The VABS-3 is a 381-item caregiver-reported measure of adaptive behavior. All items in the measure ask the frequency at which the participants performs a behavior, from 0 (never) to 2 (usually). Scores are age-referenced standard scores. Domain scores range from 20-140. Lower scores indicate more lower adaptive behavior. The expected change is an increase in the score.
Week 1 (initial assessment) to week 22 (follow-up)
Shalock Quality of Life Questionnaire
Time Frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The Shalock Quality of Life Questionnaire is a 40-item self- and caregiver-reported measure of quality of life. Each question prompts the informant to choose one of three options (differing by item) based on which seems most appropriate to them. Higher scores indicate lower quality of life. Domain scores range from 10-30. The expected change is a decrease in score.
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Vanessa Bal, PhD, Rutgers University - New Brunswick

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro 2021001254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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