Adapting BA for Minimally Verbal Autistic Adults

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06064422
• Other study ID #: Pro 2021001254
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Vanessa Bal, PhD
• Phone: 848-445-9384
• Email: lifespanlab[@]gsapp.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 30, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Depression

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Rutgers University - New Brunswick	Piscataway	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)	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.	Week 1 (initial assessment) to week 22 (follow-up)
Secondary	Shalock Quality of Life Questionnaire	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.	Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)