CompletedNot Applicable

Adapting BA for Minimally Verbal Autistic Adults

United States9 participantsStarted 2023-11-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Glasgow Depression Scale for Intellectual Disability (GDS)

Timeframe: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

Anxiety Depression and Mood Scale (ADAMS)

Timeframe: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

Mood, Interest, & Pleasure Questionnaire (MIPQ)

Timeframe: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

Trial details

NCT IDNCT06064422

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-30

View on ClinicalTrials.gov More Autism trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Glasgow Depression Scale for Intellectual Disability (GDS)

Timeframe: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

Anxiety Depression and Mood Scale (ADAMS)

Timeframe: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

Mood, Interest, & Pleasure Questionnaire (MIPQ)

Timeframe: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)