Back to resultsAdapting BA for Minimally Verbal Autistic Adults
Primary Purpose
Autism, Depression, Autism Spectrum Disorder With Impaired Functional Language
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BeatIt-MV
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring behavioral activation
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BeatIt-MV Treatment Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT06064422
First Posted
September 25, 2023
Last Updated
October 5, 2023
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT06064422
Brief Title
Adapting BA for Minimally Verbal Autistic Adults
Official Title
Adaptation of a Behavioral Activation Treatment to Treat Depression in Autistic Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Depression, Autism Spectrum Disorder With Impaired Functional Language, Autism Spectrum Disorder
Keywords
behavioral activation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BeatIt-MV Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BeatIt-MV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glasgow Depression Scale for Intellectual Disability (GDS)
Description
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.
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Title
Anxiety Depression and Mood Scale (ADAMS)
Description
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.
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Title
Mood, Interest, & Pleasure Questionnaire (MIPQ)
Description
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.
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Secondary Outcome Measure Information:
Title
Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)
Description
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.
Time Frame
Week 1 (initial assessment) to week 22 (follow-up)
Title
Shalock Quality of Life Questionnaire
Description
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.
Time Frame
Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Bal, PhD
Phone
848-445-9384
Email
lifespanlab@gsapp.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Bal, PhD
Organizational Affiliation
Rutgers University - New Brunswick
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Adapting BA for Minimally Verbal Autistic Adults
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