Skip to main content
Clinical Trials/NCT06064422
NCT06064422
Active, not recruiting
Not Applicable

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

Rutgers, The State University of New Jersey1 site in 1 country15 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
Rutgers, The State University of New Jersey
Enrollment
15
Locations
1
Primary Endpoint
Glasgow Depression Scale for Intellectual Disability (GDS)
Status
Active, not recruiting
Last Updated
10 months ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
August 30, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vanessa H. Bal, PhD

Associate Professor; Karmazin & Lillard Chair in Adult Autism, Rutgers, The State University of New Jersey

Rutgers, The State University of New Jersey

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)(Week 1 (initial assessment) to week 22 (follow-up))
  • Shalock Quality of Life Questionnaire(Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up))

Study Sites (1)

Loading locations...

Similar Trials