BeatIt-MV Therapy for Minimally Verbal Autistic Adults

Overseen By Vanessa Bal, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Active psychosis, Unmanaged seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called BeatIt-MV (also known as BeatIt-2 or Behavioral Activation Intervention) to assist autistic adults who speak very little and experience depression. The goal is to determine if this program can improve their mood and daily life. Participants will attend 12 weekly sessions with a support person. This trial suits adults living in or near New Jersey or New York who have difficulty speaking, have been diagnosed with autism and depression, and have someone to assist them during the sessions. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance support for autistic adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be currently receiving other treatment for depression.

What prior data suggests that the BeatIt-MV intervention is safe for minimally verbal autistic individuals?

Research has shown that therapies like BeatIt-MV, which aim to increase activity to improve mood, are generally safe. Although specific safety data for BeatIt-MV is not yet available, similar treatments have been well-received and typically do not cause harmful effects. This trial is in an early stage, focusing on the treatment's practicality, but the positive safety record of similar therapies is encouraging. Participants can feel reassured by the safety of these types of interventions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

BeatIt-MV is unique because it focuses on enhancing communication skills in minimally verbal autistic adults through a series of personalized, interactive sessions. Unlike typical approaches that may rely on medication or general behavioral therapies, BeatIt-MV involves direct engagement with both participants and their support persons in weekly sessions designed to foster meaningful communication. Researchers are excited about this treatment because it offers a hands-on, supportive framework that could lead to more effective communication improvements, potentially enhancing the quality of life for participants and their families.

What evidence suggests that the BeatIt-MV treatment might be effective for minimally verbal autistic adults?

Research shows that the BeatIt-MV therapy, a version of the BeatIt-2 program, may help autistic adults who speak very little. This trial will specifically evaluate the BeatIt-MV intervention. Studies on similar programs, like BeatIt-Aut, suggest that this type of therapy is practical and well-received by autistic adults with low mood. Although strong evidence is still being gathered on its effectiveness, the therapy encourages participation in positive activities, which has reduced depression symptoms. Early signs suggest that these interventions could improve mood and participation in this group, offering hope for the positive impact of BeatIt-MV therapy. ^{1 2 3 5 6}

Who Is on the Research Team?

Vanessa Bal, PhD

Principal Investigator

Rutgers University - New Brunswick

Are You a Good Fit for This Trial?

This trial is for minimally verbal adults over 18 with Autism Spectrum Disorder and depression, who have a support person and can travel to Rutgers University in New Jersey or New York. It's not suitable for those without these specific conditions or support.

Inclusion Criteria

Live in New Jersey or New York, or be within travel distance to Rutgers University

I have been diagnosed with Autism Spectrum Disorder and significant depression.

Minimally verbal

Exclusion Criteria

High suicide risk (i.e., with a clear plan, expressed intent or recent documented attempts)

I cannot receive treatment instructions in English.

I do not have conditions like uncontrolled seizures or psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Adapting the BeatIt-2 manual to consider specific needs of minimally verbal autistic adults

Not specified

Treatment

Participants, along with support persons, will complete 12 weekly sessions of the BeatIt-MV intervention

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BeatIt-MV

Trial Overview The study is testing BeatIt-MV, an adaptation of the BeatIt-2 intervention designed to help autistic individuals with intellectual disabilities and low mood by increasing their engagement in positive activities.

How Is the Trial Designed?

Group I: BeatIt-MV Treatment Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

Behavioral activation is a promising approach for treating depression in autistic adults, but it requires careful adaptation to address the unique needs and mechanisms relevant to this population.

The paper emphasizes the importance of understanding the facilitators and barriers to implementing behavioral activation, providing a framework for future research to establish it as an evidence-based practice for autistic adults with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of change in Behavioral Activation: Adapting depression treatment for autistic people. Bal, VH., Wilkinson, E., Glascock, V., et al.[2023]

The study identifies a phenomenon of being 'stuck' in autistic individuals, which can manifest as physical immobility and emotional passivity, and is influenced by broader social and relational dynamics.

An integrative framework was developed to address this 'stuck state' through various therapeutic approaches, suggesting that personalized, interdisciplinary support can help autistic individuals lead more fulfilling and meaningful lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical stance on response initiation in autistic adults: co-creating an integrative approach based on theory and lived experiences to act from language, via motor movement to wellbeing. Greaves-Lord, K., Alma, M., de Graaff, B., et al.[2023]

A systematic review of 52 articles on Applied Behavior Analysis (ABA) for individuals with Autistic Spectrum Disorders found that while ABA is widely discussed, there is insufficient evidence to prove its superiority over other treatment options.

The review highlighted that many studies are controversial and expensive, with only a few addressing the role of parents in implementing ABA techniques at home, indicating a need for more standardized research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applied behavior analysis and autism spectrum disorders: literature review. Fernandes, FD., Amato, CA.[2022]

In a study involving 36 children with Autism Spectrum Disorder (ASD), rhythm-based therapy was found to effectively reduce negative behaviors and increase positive affect over time, suggesting its potential as a beneficial intervention.

While both rhythm and robotic therapies initially led to greater negative affect in children, the rhythm group showed significant improvements in emotional regulation, highlighting its effectiveness in addressing core challenges associated with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the effects of rhythm and robotic interventions on repetitive behaviors and affective states of children with Autism Spectrum Disorder (ASD). Srinivasan, SM., Park, IK., Neelly, LB., et al.[2020]

Neurologic Music Therapy (NMT) significantly improved coordination skills in all 22 children with Autism Spectrum Disorder (ASD) after 8 sessions over 2 months, as measured by the Developmental Coordination Disorder Questionnaire (DCDQ).

Children using the elastic touch-display showed greater improvements in coordination compared to those using tambourines, indicating that this technological intervention may enhance the efficacy of NMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting coordination of children with ASD using neurological music therapy: A pilot randomized control trial comparing an elastic touch-display with tambourines. Cibrian, FL., Madrigal, M., Avelais, M., et al.[2021]

A systematic review and meta-analysis of 56 studies found that challenging behaviors in autistic individuals tend to decrease over time, indicating a potential for improvement as they age.

The reduction in challenging behaviors was more pronounced in studies with longer follow-up periods and in older participants at the final assessment, suggesting that age and time may play important roles in the trajectory of these behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal studies of challenging behaviours in autistic children and adults: A systematic review and meta-analysis. Adams, D., Dargue, N., Paynter, J.[2023]

Integrating an anchoring habit formation strategy into app-based meditation is both feasible and effective for helping autistic adults establish meditation habits, which can lead to significant reductions in depressive symptoms over a 6-month period.

This study highlights app-based meditation as a promising long-term self-care solution for managing depression in autistic adults, suggesting it should be considered by mental health providers and policymakers for broader implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-based meditation habits maintain reductions in depression symptoms among autistic adults. Stecher, C., Pagni, BA., Cloonan, S., et al.[2023]

A review of 41 studies from 1980 to 2017 found a lack of consistent evidence-based psychosocial interventions for improving social functioning in autistic adults without intellectual disabilities.

The studies varied widely in their goals and methods, highlighting a significant need for more rigorous research to create effective interventions that can be applied in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial Interventions Targeting Social Functioning in Adults on the Autism Spectrum: a Literature Review. Pallathra, AA., Cordero, L., Wong, K., et al.[2020]

Jogging was more effective than walking in reducing self-stimulatory behaviors in a five-year-old boy with autism, particularly in decreasing physical self-stimulation and 'out of seat' behavior.

The positive effects of jogging were immediate and lasted for up to 40 minutes after the exercise, suggesting that this type of physical activity could be beneficial for managing certain behaviors in children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The differential and temporal effects of antecedent exercise on the self-stimulatory behavior of a child with autism. Celiberti, DA., Bobo, HE., Kelly, KS., et al.[2019]

The GamerFit-ASD intervention, a 12-week telehealth coaching and exergaming program, was successfully beta-tested with 5 autistic youth aged 10-14, showing high feasibility and engagement, as all participants attended all sessions and completed an average of 50 minutes of exergaming per week.

Participants and their parents reported positive experiences with the intervention, highlighting its accessibility and enjoyment, which suggests that such programs could effectively promote physical activity and potentially improve health outcomes for autistic youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GamerFit-ASD beta test: adapting an evidence-based exergaming and telehealth coaching intervention for autistic youth. Hatfield, DP., Must, A., Kennedy, W., et al.[2023]

The PuzzleWalk mobile app was found to be user-friendly and effective for promoting physical activity among both adults with and without autism spectrum disorder (ASD), based on a study involving 18 participants.

Qualitative interviews revealed important insights into the specific health and social needs of adults with ASD, highlighting areas for improvement in future iterations of the app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability inquiry of a gamified behavior change app for increasing physical activity and reducing sedentary behavior in adults with and without autism spectrum disorder. Lee, D., Frey, GC., Min, A., et al.[2021]

In a study involving 4 individuals with autism, antecedent exercise was found to reduce problem behaviors for 3 out of 4 participants, suggesting that exercise can be an effective strategy for managing such behaviors.

The research utilized a structured approach with multiple schedules to assess the impact of exercise compared to leisure activities and social interactions, indicating that while exercise was beneficial, its effects were not uniform across all participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of antecedent exercise on behavior maintained by automatic reinforcement using a three-component multiple schedule. Morrison, H., Roscoe, EM., Atwell, A.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1077722925000859

Feasibility of BeatIt-Aut: Behavioral activation therapy ... The current study aimed to evaluate the feasibility, acceptability, and preliminary outcomes of BeatIt-Aut, an adaptation of BeatIt for use with ...

2. withpower.com withpower.com/trial/phase-depression-10-2023-fa81a

BeatIt-MV Therapy 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 ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06064422/adapting-ba-for-minimally-verbal-autistic-adults

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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05030610

Adaptation of a Behavioral Activation Treatment to Treat ... Data will demonstrate the feasibility and acceptability of the adapted BeatIt intervention for autistic adults and provide preliminary evidence for ...

5. researchgate.net researchgate.net/publication/395819108_Feasibility_of_BeatIt-Aut_Behavioral_activation_therapy_adapted_for_the_treatment_of_depression_in_autistic_adults

Feasibility of BeatIt-Aut: Behavioral activation therapy ... Feasibility of BeatIt-Aut: Behavioral activation therapy adapted for the treatment of depression in autistic adults. September 2025; Cognitive ...

6. withpower.com withpower.com/clinical-trials/for-autism-near-new-york-ny?page=2

Top Autism Clinical Trials near New York, NY | Power BeatIt-MV Therapy for Minimally Verbal Autistic Adults. Piscataway, New ... Phase 1 trials are the trials to collect safety data in humans. Phase 2 ...