AutismNCT06064422
Adapting BA for Minimally Verbal Autistic Adults
A study testing BeatIt-MV in people with Autism and Depression, run by Rutgers, The State University of New Jersey at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism, Depression, Autism Spectrum Disorder With Impaired Functional Language
- What is being tested?
- BeatIt-MV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University - New Brunswick
Piscataway, New Jersey, 08854
About this study
Official title: Adaptation of a Behavioral Activation Treatment to Treat Depression in Autistic Adults
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.
Read the 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
- Being tested
- BeatIt-MV
- Keywords
- behavioral activation
- Medical subject headings
- Autistic Disorder, Depression, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeatIt-MVBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BeatIt-MV Treatment Group | Experimental | 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. Receives: Behavioral: BeatIt-MV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Nov 2023
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa H. Bal, PhD, Rutgers, The State University of New Jersey
- Investigators
- Vanessa Bal, PhD, Principal investigator, Rutgers University - New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064422
- Sponsor's protocol ID
- Pro 2021001254
- Status last verified
- Apr 2026
- First submitted
- 25 Sep 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of a Behavioral Activation Treatment to Treat Depression in Autistic Adults
- ClinicalTrials.gov ID
- NCT06064422
- Acronym / sponsor ID
- Pro 2021001254
- Conditions
- Autism, Depression, Autism Spectrum Disorder With Impaired Functional Language, Autism Spectrum Disorder
- Keywords
- behavioral activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BeatIt-MV Treatment Group | Experimental | Behavioral: BeatIt-MVParticipants, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeatIt-MVBeatIt-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. | Behavioural | BeatIt-MV Treatment Group |
Primary outcome
Glasgow Depression Scale for Intellectual Disability (GDS)
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
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)
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
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)
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
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.
2 secondary outcomes
Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)
Time frame: Week 1 (initial assessment) to week 22 (follow-up)
Shalock Quality of Life Questionnaire
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Bal, PhD principal investigator
Rutgers University - New Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BeatIt-MV in people with Autism and Depression, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Depression Scale for Intellectual Disability (GDS) (time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.