Adapting BA for Minimally Verbal Autistic Adults

NCT ID: NCT06064422

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-08-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BeatIt-MV Treatment Group

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.

Group Type: EXPERIMENTAL

BeatIt-MV

Intervention Type: 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.

Interventions

BeatIt-MV

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Vanessa H. Bal, PhD

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vanessa Bal, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University - New Brunswick

Locations

Rutgers University - New Brunswick

Piscataway, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro 2021001254

Identifier Type: -

Identifier Source: org_study_id