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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of Behavior Analytic Intervention in reducing challenging behaviors in autistic patients during needle-related procedures. The goal is to increase patient comfort in these medical situations and assess whether caregivers and patients find the therapy acceptable. This study targets autistic individuals who have exhibited difficult behaviors during needle procedures at Boston Medical Center and can attend sessions there at least twice a month. As an unphased trial, it offers a unique opportunity for patients to contribute to innovative research that could enhance comfort during medical procedures.

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 prior data suggests that this behavior analytic intervention is safe for patients with Autism Spectrum Disorder?

Studies have shown that behavior-based treatments, like the one tested in this trial, are generally safe and well-tolerated. For example, applied behavior analysis (ABA), which uses similar methods, has helped children with autism improve social skills, communication, and language. More than 20 studies have demonstrated that long-term ABA therapy can lead to better outcomes for many children with autism.

However, potential risks exist, such as increased mental health hospitalizations for those receiving ABA. Specifically, one study found a 30% higher chance of mental health hospitalizations for those who received ABA.

Overall, while the treatment shows promise in improving certain behaviors and skills, potential participants should weigh both the benefits and the risks, such as the possibility of increased mental health challenges. Discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavior Analytic Intervention for autism because it specifically targets challenging behaviors during needle-related procedures, a common stressor for autistic children. Unlike standard care options that often rely on generalized behavioral therapies, this approach provides personalized support by involving both caregivers and clinicians in simulation sessions. This collaborative and focused method aims to reduce anxiety and improve cooperation during medical procedures, potentially enhancing the overall healthcare experience for autistic individuals.

What evidence suggests that this behavior analytic intervention is effective for Autism Spectrum Disorder?

Research shows that behavior-based treatments, such as Applied Behavior Analysis (ABA), work well for children with Autism Spectrum Disorder (ASD). Studies find that ABA programs help improve crucial skills like making friends, talking, and understanding language. Notably, over 89% of studies report significant improvements in thinking and social skills for children in ABA therapy. These treatments also help manage challenging behaviors associated with autism. The structured approach of ABA can greatly enhance everyday life skills for children with ASD. ^{1 2 6 7 8}

Who Is on the Research Team?

Jacqueline McKendry, MS BCBA LABA

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

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)

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8702444/

Patient Outcomes After Applied Behavior Analysis for ... Meta-analyses suggest that ABA results in small to moderate improvement in adaptive behavior, including socialization, communication, and expressive language.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1750946718300485

The effectiveness of applied behavior analytic interventions ... The findings indicated that ABA programs are moderately to highly effective bringing significant benefits for children with ASD in the aforementioned areas.

3. advancedautism.com advancedautism.com/post/success-rates-of-aba-therapy

Success Rates of ABA Therapy Research indicates that over 89% of studies report significant improvements in children undergoing ABA, including enhanced cognition, communication, social ...

4. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-022-04412-1

Comprehensive ABA-based interventions in the treatment of ... Many studies display promising results for interventions that are based on Applied Behavior Analysis (ABA) in the treatment of autism ...

5. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2819784

Determining Associations Between Intervention Amount ... This meta-analysis investigates if the amount of intervention provided to young autistic children is associated with improved child ...

6. bmj.com bmj.com/content/383/bmj-2023-076733

Autism intervention meta-analysis of early childhood ... Conclusion The available evidence on interventions to support young autistic children has approximately doubled in four years. Some evidence ...

7. autismspeaks.org autismspeaks.org/applied-behavior-analysis

Applied Behavior Analysis (ABA) More than 20 studies have established that intensive and long-term therapy using ABA principles improves outcomes for many but not all children with autism.

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/13623613251390604

Mental health outcomes associated with applied behavior ... Overall, applied behavior analysis receipt was associated with 30% higher odds of experiencing a mental health hospitalization (odds ratio = ...