BeatIt-MV Therapy for Minimally Verbal Autistic Adults

Recruiting in Palo Alto (17 mi)

Overseen by Vanessa Bal, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Active psychosis, Unmanaged seizures, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment BeatIt-MV for minimally verbal autistic adults?

Behavioral Activation, a component of the treatment, is widely accepted for treating depression in other populations and is being adapted for autistic adults, suggesting potential benefits. Additionally, app-based meditation, another behavioral intervention, has shown effectiveness in reducing depression symptoms in autistic adults, indicating that similar behavioral strategies may be beneficial. ^{1 2 3 4 5}

Is BeatIt-MV Therapy safe for humans?

The research articles do not provide specific safety data for BeatIt-MV Therapy, but they discuss related interventions like behavioral activation and exercise, which are generally considered safe for humans. ^{1 6 7 8 9}

How is the BeatIt-MV treatment different from other treatments for minimally verbal autistic adults?

BeatIt-MV is unique because it adapts behavioral activation, a therapy typically used for depression, to help autistic adults by focusing on increasing engagement in meaningful activities and reducing feelings of being 'stuck'. This approach is novel for autism as it targets both physical and emotional aspects to improve overall well-being. ^{1 2 10 11 12}

Research Team

Vanessa Bal, PhD

Principal Investigator

Rutgers University - New Brunswick

Eligibility Criteria

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 am 18 years old or older.

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

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.

Trial Timeline

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

Treatment Details

Interventions

• BeatIt-MV (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Jonathan Holloway

Rutgers, The State University of New Jersey

Chief Executive Officer since 2020

PhD in History from Yale University

Dr. Brian Strom

Rutgers, The State University of New Jersey

Chief Medical Officer since 2014

MD from Rutgers New Jersey Medical School

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mechanisms of change in Behavioral Activation: Adapting depression treatment for autistic people. [2023]

2. Brazil pubmed.ncbi.nlm.nih.gov

Applied behavior analysis and autism spectrum disorders: literature review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Longitudinal studies of challenging behaviours in autistic children and adults: A systematic review and meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

App-based meditation habits maintain reductions in depression symptoms among autistic adults. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Psychosocial Interventions Targeting Social Functioning in Adults on the Autism Spectrum: a Literature Review. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The differential and temporal effects of antecedent exercise on the self-stimulatory behavior of a child with autism. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

GamerFit-ASD beta test: adapting an evidence-based exergaming and telehealth coaching intervention for autistic youth. [2023]

8. England 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

An evaluation of antecedent exercise on behavior maintained by automatic reinforcement using a three-component multiple schedule. [2021]

10. Switzerland 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. [2023]

11. Netherlands 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). [2020]

12. United States 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. [2021]