Adapting BA for Minimally Verbal Autistic Adults

NCT06064422 | Completed

• 1 other identifier: Pro 2021001254
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Depression; Autism Spectrum Disorder; Autism Spectrum Disorder With Impaired Functional Language

Keywords

behavioral activation

Outcome Measures

Primary Outcomes (3)

• Glasgow Depression Scale for Intellectual Disability (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. Scores range from 0-32. The expected change is a decrease in the score.

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

• 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. Total scores range from 0-84. The expected change is a decrease in the score.

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

• Mood, Interest, & Pleasure Questionnaire (MIPQ)

  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.

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

Secondary Outcomes (2)

• 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 Arms (1)

BeatIt-MV Treatment Group

EXPERIMENTAL

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.

Behavioral: BeatIt-MV

Interventions

BeatIt-MV BEHAVIORAL

BeatIt-MV, designed to be implemented with minimally verbal autistic individuals, is an adaptation of BeatIt-2. The intervention aims to improve mood and decrease depressive symptoms through an increase in meaningful engagement in recreational, domestic, and social/leisure activities.

BeatIt-MV Treatment Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University - New Brunswick

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Depression; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

• Vanessa 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, Rutgers, The State University of New Jersey

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 3, 2023
• Study Start: November 1, 2023
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)