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

March 30, 2023 updated by: Vanessa H. Bal, PhD, Rutgers, The State University of New Jersey

Treating Depression in Autistic Adults: A Feasibility Trial of an Adapted Behavioral Activation Program

The present study aims to adapt and evaluate the feasibility of the BeatIt behavioral activation intervention for people with intellectual disabilities and low mood to be implemented with autistic individuals, with and without intellectual disabilities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study has two specific aims:

  1. Adapt BeatIt materials for use with autistic adults with and without Intellectual Disability (ID). Focus groups engaging key stakeholders will inform the adaptation of BeatIt for autistic adults (i.e., BeatIt-ASD). A stakeholder advisory team will provide input through the duration of the study.
  2. Evaluate the feasibility, acceptability, and preliminary efficacy of BeatIt-ASD for autistic adults. This includes examining if the data demonstrate the feasibility and acceptability of the BeatIt-ASD program for autistic adults and provide preliminary evidence for behavioral change (i.e., increased engagement in meaningful activities and reduced depressive symptoms).

Data will demonstrate the feasibility and acceptability of the adapted BeatIt intervention for autistic adults and provide preliminary evidence for reduction of depression symptoms via regulation of routines and achievement of meaningful goals.

Study Type

Interventional

Enrollment (Actual)

13

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 Locations

  • United States
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Rutgers University - New Brunswick

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Have a confirmed diagnosis of Autism Spectrum Disorders (ASD)
  2. Have a best estimate diagnosis of clinically significant depressive symptoms by the study team. This will be based on DSM-5 criteria or DM-ID (Diagnostic Manual - Intellectual Disability).
  3. Have a support person willing to participate
  4. Live in New Jersey or New York, or be within travel distance to Rutgers University
  5. Half of participants will have a best estimate diagnosis of mild to moderate intellectual disability and half will not have intellectual disability. This will be based on participant cognitive assessment and self and/or supporter report of adaptive function during the Baseline visit.

Exclusion Criteria:

  1. Are unable to speak and understand English fluently (because the instruments being investigated are currently only validated in English and the focus group and intervention will be delivered in English).
  2. Are currently enrolled in another behavioral therapy or psychotherapy targeting depression. Participants will not be excluded if they are currently taking medication.

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: Intervention Group
Participants, along with a support person, will complete 12 weekly sessions of the BeatIt-ASD intervention. The support person will complete an initial session before commencement of the 12 weekly sessions.
Behavioral: BeatIt-ASD
BeatIt-ASD, designed to be implemented with autistic individuals, is an adaptation of BeatIt. 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
Change in distress on Patient Health Questionnaire (PHQ-9)
Time Frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The PHQ-9 is a 9-item self-reported questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more distress. The PHQ-9 is administered to those without intellectual disability.
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in distress on Glasgow Depression Scale (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. The GDS is administered to those with intellectual disability.
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in distress on 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. The ADAMS is administered to those with intellectual disability.
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change on Adult Behavior Checklist (ABCL)
Time Frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The ABCL is a caregiver-report measure of adaptive functioning and psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true. Higher scores equal more symptoms.
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change on Adult Self Report (ASR)
Time Frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The ASR is a self-reported measure of adaptive functioning and psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true. Higher scores equal more symptoms.
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in frequency of activities on Index of Community Involvement (ICI)
Time Frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The ICI is a 48-item self- and caregiver-reported measure of community involvement over the previous month. All items on the measure ask the frequency of participating in activity from 0 (Never) to 5 (Daily).
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in frequency of activities on Index of Participation in Domestic Life (IPDL)
Time Frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The IPDL is an 18-item self- and caregiver-reported measure of participation in domestic activities over the previous month. All items on the measure ask in what manner a participant completed domestic activities from 0 (Did alone without prompting) to 2 (Did not do).
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in behavioral activation on Behavioral Activation for Depression Scale (BADS)
Time Frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The BADS is a 25-item self-reported measure of behaviors and thoughts related to depression. All items on the measure ask the participant to rate how much each statement describes them from 0 (not at all) to 6.
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in adaptive behavior on Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)
Time Frame: Week 1 (initial assessment) to week 16 (outcome) 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).
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in quality of life on 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.
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

Collaborators

Governor's Council for Medical Research and Treatment of Autism

Investigators

  • Principal Investigator: Vanessa H 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)

August 25, 2021

Primary Completion (Actual)

December 7, 2022

Study Completion (Actual)

December 7, 2022

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2021001254

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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