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

Primary Purpose

Autism Spectrum Disorder, Depression, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BeatIt-ASD
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring behavioral activation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rutgers University - New Brunswick

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in distress on Patient Health Questionnaire (PHQ-9)
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.
Change in distress on Glasgow Depression Scale (GDS)
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.
Change in distress on Anxiety Depression and Mood Scale (ADAMS)
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.
Change on Adult Behavior Checklist (ABCL)
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.
Change on Adult Self Report (ASR)
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.
Change in frequency of activities on Index of Community Involvement (ICI)
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).
Change in frequency of activities on Index of Participation in Domestic Life (IPDL)
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).
Change in behavioral activation on Behavioral Activation for Depression Scale (BADS)
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.

Secondary Outcome Measures

Change in adaptive behavior on Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)
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).
Change in quality of life on Shalock Quality of Life Questionnaire
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.

Full Information

First Posted
August 26, 2021
Last Updated
March 30, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Governor's Council for Medical Research and Treatment of Autism
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1. Study Identification

Unique Protocol Identification Number
NCT05030610
Brief Title
Adaptation of a Behavioral Activation Treatment to Treat Depression in Autistic Adults
Official Title
Treating Depression in Autistic Adults: A Feasibility Trial of an Adapted Behavioral Activation Program
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
December 7, 2022 (Actual)
Study Completion Date
December 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Governor's Council for Medical Research and Treatment of Autism

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The study has two specific aims: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Depression, Depressive Symptoms
Keywords
behavioral activation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BeatIt-ASD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in distress on Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Title
Change in distress on Glasgow Depression Scale (GDS)
Description
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.
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Title
Change in distress on Anxiety Depression and Mood Scale (ADAMS)
Description
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.
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Title
Change on Adult Behavior Checklist (ABCL)
Description
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.
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Title
Change on Adult Self Report (ASR)
Description
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.
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Title
Change in frequency of activities on Index of Community Involvement (ICI)
Description
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).
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Title
Change in frequency of activities on Index of Participation in Domestic Life (IPDL)
Description
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).
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Title
Change in behavioral activation on Behavioral Activation for Depression Scale (BADS)
Description
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.
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Secondary Outcome Measure Information:
Title
Change in adaptive behavior on Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)
Description
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).
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Title
Change in quality of life on Shalock Quality of Life Questionnaire
Description
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.
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a confirmed diagnosis of Autism Spectrum Disorders (ASD) 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). Have a support person willing to participate Live in New Jersey or New York, or be within travel distance to Rutgers University 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: 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). Are currently enrolled in another behavioral therapy or psychotherapy targeting depression. Participants will not be excluded if they are currently taking medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa H Bal, PhD
Organizational Affiliation
Rutgers University - New Brunswick
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University - New Brunswick
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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