Adapting BA for Minimally Verbal Autistic Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Autism, Depression, Autism Spectrum Disorder With Impaired Functional Language, Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: BeatIt-MV


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BeatIt-MV Treatment Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral activation