Behavior Analytic Support for Autism

Overseen By Jacqueline McKendry, MS BCBA LABA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Non-English speakers, No needle phobia, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 months

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness of the behavior analytic intervention in reducing the number of challenging behaviors exhibited by patients with Autism Spectrum Disorder (ASD) while increasing compliance with needle-related simulations and procedures. A second purpose is to assess the social validity of this study as evidenced by patient and/or caregiver acceptability. The study wil take place at Boston Medical Center (BMC). A Single Subject Design (SSD) wil be utilized as it allows for detailed, individualized assessment of how interventions affect behavior over time in this type of behavior analytic research. By focusing on each participant as an individual and having each participant act as their own control, it demonstrates clear cause-and-effect relationships, showing how behavior changes with the introduction or withdrawal of an intervention. This method is flexible, enabling ongoing adjustments to treatments based on real-time data, making it particularly useful in personalized interventions and ensuring effectiveness for patients with unique needs such as those who would be eligible to enroll and participate in this study.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Behavior Analytic Intervention for autism?

Research shows that behavior analytic interventions, like Applied Behavior Analysis (ABA), are effective in improving communication, social skills, and reducing problem behaviors in children with autism. These interventions are based on scientific teaching principles and have been identified as a preferred treatment choice for autism spectrum disorder. ^{1 2 3 4 5}

Is Behavior Analytic Support for Autism safe for humans?

Behavior Analytic Support, also known as Applied Behavior Analysis (ABA), has been used for over 50 years and is generally considered safe, but some concerns have been raised about potential harm from certain procedures. Additionally, a study found that 75% of Registered Behavior Technicians reported sustaining an injury, and 36% reported their clients sustained some type of injury during interventions for severe problem behavior. ^{2 4 6 7 8}

How is Behavior Analytic Intervention different from other treatments for autism?

Behavior Analytic Intervention is unique because it uses a systematic approach to understand and modify behavior, focusing on practical and measurable outcomes. Unlike some other treatments, it is backed by extensive research and is often implemented by trained professionals, making it a well-supported option for individuals with autism. ^{5 9 10 11 12}

Research Team

Jacqueline McKendry, MS BCBA LABA

Principal Investigator

Boston Medical Center

Eligibility Criteria

This trial is for individuals with Autism Spectrum Disorder (ASD) who need to undergo needle-related procedures. It aims to help them by reducing challenging behaviors and increasing compliance during these medical visits.

Inclusion Criteria

Caregivers of autistic patients who have been historically engaged in challenging behaviors during needle-related procedures at a Boston Medical Center (BMC)

I am over 3 years old, diagnosed with autism at BMC, and struggle with needles.

BMC Medical Providers (i.e., phlebotomists, medical doctors, registered nurses, certified nursing assistants, registered dieticians, and medical assistants) who either: 1) order needle-related medical procedures for participants to be conducted during procedure visits and/or 2) are present to conduct the ordered procedure

Exclusion Criteria

No history of challenging behaviors in medical appointments involving the presentation of needle(s)

I cannot visit the medical center twice a month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive behavior analytic interventions to reduce challenging behaviors during needle-related procedures

4 months

At least 2 visits per month (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Behavior Analytic Intervention

Trial Overview The study tests a behavior analytic intervention designed specifically for autistic patients facing needle-related hospital visits. The effectiveness and acceptability of this treatment will be evaluated using a Single Subject Design at Boston Medical Center.

Participant Groups

Group I: Treatment Packet Experimental Treatment 1 Intervention

3-5 autistic BMC patients who have a history of engaging in challenging behaviors during needle-related procedures who are able to attend simulation sessions at BMC at least 2 times per month. A caregiver and clinician will also be recruited for each child participant.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Findings from Research

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]

A review of 213 studies involving 358 individuals with autism found that behavioral interventions are generally effective in reducing problem behaviors, with some interventions showing significantly better results than others.

Interventions that were preceded by a functional analysis were notably more effective, highlighting the importance of understanding the specific behaviors before applying treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of behavioral interventions for reducing problem behavior in persons with autism: an updated quantitative synthesis of single-subject research. Heyvaert, M., Saenen, L., Campbell, JM., et al.[2019]

A survey of Registered Behavior Technicians (RBTs) revealed that while some received adequate initial and ongoing training for working with clients exhibiting severe problem behavior, a concerning 13% reported no initial training and 29% reported no ongoing training.

The study highlighted safety concerns, as 75% of RBTs reported sustaining injuries while working, and 36% noted that their clients also experienced injuries, indicating a need for improved training and support in handling severe behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Registered Behavior Technicians' Training Experiences for Severe Problem Behavior: A Survey. Ralston, AW., Brown, K.[2023]

The study involved 36 children aged 6-17 with autism spectrum disorder (ASD) who received brief applied behavior analysis (ABA) interventions during hospitalization, showing that the intervention was well-accepted by families and staff, and led to perceived improvements in clinical severity ratings.

While the ABA intervention did not significantly change challenging behaviors as reported by parents or affect the length of hospitalization, it indicated potential benefits in staffing and restraint levels, suggesting that ABA-based interventions may be feasible and beneficial in hospital settings for children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Challenging Behavior During Hospitalizations for Children with Autism: A Pilot Applied Behavior Analysis Randomized Controlled Trial. Sanders, K., Staubitz, J., Juárez, AP., et al.[2021]

A survey of 901 Board Certified Behavior Analysts revealed that most professionals have little knowledge of Naturalistic Developmental Behavior Interventions, despite strong evidence supporting their effectiveness for children on the autism spectrum.

The findings suggest a need for increased training and updated certification requirements to align with current research, as many professionals do not believe these interventions are effective or appropriate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keeping up with the evidence base: Survey of behavior professionals about Naturalistic Developmental Behavioral Interventions. Hampton, LH., Sandbank, MP.[2022]

Applied Behavior Analysis (ABA) has been extensively studied for over 40 years, particularly in its effectiveness for individuals diagnosed with autism spectrum disorder (ASD), demonstrating its significance in both research and clinical settings.

The paper discusses key contributions to ABA and offers recommendations for future advancements in behavioral interventions, highlighting the ongoing evolution of practices in the next 40 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Our Understanding of Behavioral Intervention: 1980 to 2020 for Individuals Diagnosed with Autism Spectrum Disorder. Leaf, JB., Cihon, JH., Ferguson, JL., et al.[2021]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

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

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

Efficacy of behavioral interventions for reducing problem behavior in persons with autism: an updated quantitative synthesis of single-subject research. [2019]

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

Producing meaningful improvements in problem behavior of children with autism via synthesized analyses and treatments. [2014]

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

Behavioral treatments in autism spectrum disorder: what do we know? [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Evolution of research on interventions for individuals with autism spectrum disorder: implications for behavior analysts. [2021]

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

Concerns About ABA-Based Intervention: An Evaluation and Recommendations. [2023]

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

Registered Behavior Technicians' Training Experiences for Severe Problem Behavior: A Survey. [2023]

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

Addressing Challenging Behavior During Hospitalizations for Children with Autism: A Pilot Applied Behavior Analysis Randomized Controlled Trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Keeping up with the evidence base: Survey of behavior professionals about Naturalistic Developmental Behavioral Interventions. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Using behavior analysis to examine the outcomes of unproven therapies: an evaluation of hyperbaric oxygen therapy for children with autism. [2021]

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

Understanding and Intervening With the Challenging Behavior of Young Children With Autism Spectrum Disorder. [2019]

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

Advances in Our Understanding of Behavioral Intervention: 1980 to 2020 for Individuals Diagnosed with Autism Spectrum Disorder. [2021]