Clinical trial NCT06064422: Adapting BA for Minimally Verbal Autistic Adults
Official title: Adaptation of a Behavioral Activation Treatment to Treat Depression in Autistic Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism
Depression
Autism Spectrum Disorder With Impaired Functional Language
Autism Spectrum Disorder
Keywords: behavioral activation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Glasgow Depression Scale for Intellectual Disability (GDS)
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
measure: Anxiety Depression and Mood Scale (ADAMS)
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
measure: Mood, Interest, & Pleasure Questionnaire (MIPQ)
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Secondary outcomes:
measure: Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)
timeFrame: Week 1 (initial assessment) to week 22 (follow-up)
measure: Shalock Quality of Life Questionnaire
timeFrame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University - New Brunswick
state: New Jersey
Study officials:
affiliation: Rutgers University - New Brunswick
name: Vanessa Bal, PhD
role: PRINCIPAL_INVESTIGATOR
References: