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Completed

NCT Number: NCT06064422

Adapting BA for Minimally Verbal 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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autism Spectrum Disorder With Impaired Functional Language Autistic Disorder Behavior Behavioral Symptoms Child Development Disorders, Pervasive Depression Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University - New Brunswick

Piscataway, New Jersey, 08854, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BeatIt-MV

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)

    Time frame: Week 1 (initial assessment) to week 22 (follow-up)

    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.

  2. Shalock Quality of Life Questionnaire

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

    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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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