Adapting BA for Minimally Verbal Autistic Adults

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder With Impaired Functional Language; Autism Spectrum Disorder; Autism; Depression
• Interventions: Behavioral: BeatIt-MV

• Registration Number: NCT06064422
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-10-03
• Study Start: 2023-11-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-04-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BeatIt-MV Treatment Group	BeatIt-MV	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.

Primary Outcome Measures

Name	Time	Method
Glasgow Depression Scale for Intellectual Disability (GDS)	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)	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)	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 Outcome Measures

Name	Time	Method
Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)	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.
Shalock Quality of Life Questionnaire	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.

Trial Locations

Locations (1)

Rutgers University - New Brunswick; 🇺🇸 Piscataway, New Jersey, United States