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

NCT05030610 | Completed

• 1 other identifier: Pro2021001254
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Depression; Depressive Symptoms

Keywords

behavioral activation

Outcome Measures

Primary Outcomes (8)

• 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.

  Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

• 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.

  Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

• 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.

  Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

• 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.

  Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

• 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.

  Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

• 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).

  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)

  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)

  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 Outcomes (2)

• Change in adaptive behavior on Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)

  Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

• Change in quality of life on Shalock Quality of Life Questionnaire

  Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

BeatIt-ASD BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Governor's Council for Medical Research and Treatment of Autism: collaborator

Study Sites (1)

Rutgers University - New Brunswick

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Depression

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Vanessa H Bal, PhD

  Rutgers University - New Brunswick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Karmazin & Lillard Chair in Adult Autism

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 1, 2021
• Study Start: August 25, 2021
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)