Virtual Therapy for Developmental Disabilities

Overseen By Allison Wainer, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: High aggression, Medical instability, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3-6 months

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of virtual therapy in helping children with syndromic intellectual and developmental disorders improve communication and behavior. It uses an adapted telehealth version of functional behavioral training (FBT) and compares it to usual positive parenting strategies. Participants will attend virtual sessions and complete assessments over 3-6 months. Ideal candidates are children aged 2-12 with a known genetic syndrome and developmental delays, exhibiting disruptive behaviors suitable for remote coaching. Caregivers must consent in English and participate in weekly sessions. As an unphased trial, this study provides families with the opportunity to explore innovative therapy options that could enhance their child's development.

Will I have to stop taking my current medications?

The trial requires that your current medications be stable for at least 3 months before starting. If your medications have been stable, you can continue taking them during the study.

What prior data suggests that this telehealth functional behavioral therapy is safe for individuals with developmental disabilities?

Research has shown that functional behavioral training (FBT) delivered through telehealth is generally safe and well-tolerated for individuals with developmental disorders. Studies involving young children with autism spectrum disorder indicate that telehealth-based FBT rarely causes problems or safety issues, confirming its safety. FBT has also been successfully applied in other contexts, demonstrating a strong track record. While each person is unique and experiences may vary, current evidence supports the safety of this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Functional Behavioral Training (FBT) because it offers a fresh approach to managing developmental disabilities through virtual therapy. Unlike traditional in-person therapies, FBT can be delivered remotely, making it accessible to families who may face geographical or logistical barriers. This virtual delivery method not only increases accessibility but also allows for consistent support and real-time feedback in the home environment, which can be critical for effective behavioral interventions. By integrating technology, FBT provides an innovative, flexible, and potentially more engaging way to support individuals with developmental disabilities, which could lead to improved outcomes and greater convenience for families.

What evidence suggests that this trial's treatments could be effective for developmental disabilities?

Research has shown that Functional Behavioral Training (FBT), which participants in this trial may receive, can improve communication and behavior in individuals with developmental disorders. Studies have found that FBT can reduce challenging behaviors by about 72%. This method works by identifying the reasons behind certain behaviors, allowing for targeted solutions. Additionally, FBT is equally effective through telehealth as in person, enabling families to receive help and advice from home, making it more convenient and accessible. Overall, these findings suggest that FBT can positively impact individuals with intellectual and developmental disabilities. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for children aged 2-12 with certain genetic syndromes like Fragile X or Rett Syndrome, who have moderate to profound intellectual disabilities and behavioral challenges. They need a caregiver who speaks English and can attend weekly online sessions. Kids unstable medically or psychiatrically, recently changing treatments, or lacking tech access for telehealth are excluded.

Inclusion Criteria

You have been diagnosed with global developmental delay or intellectual disability.

The child's challenging behavior can be managed through remote coaching for parents, as determined by the clinician based on the severity of the behaviors.

My caregiver can attend weekly sessions.

Exclusion Criteria

Limitations in technology access that may hinder participation in remote trial (e.g., declining support provided by study participation)

I haven't changed my medication or therapy significantly in the last 3 months.

Medical or psychiatric instability that may limit study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telehealth functional behavioral therapy (FBTsIDD) with weekly or biweekly virtual intervention visits

3-6 months

Weekly or biweekly virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Functional Behavioral Training (FBT)

Trial Overview

The study tests an adapted telehealth functional behavioral therapy (FBTsIDD) aimed at improving communication and behavior in kids with developmental disorders. It involves virtual assessments and regular online sessions with therapists over 3-6 months.

How Is the Trial Designed?

Group I: Functional Behavioral Training Experimental Treatment 1 Intervention

Group II: Positive Parenting Strategies-Treatment As Usual Active Control 1 Intervention

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

Functional communication training can be beneficial for treating severe behavior problems in individuals with communication deficits, but it may not be effective enough on its own for all patients.

Combining functional communication training with punishment strategies led to the most significant and consistent reductions in destructive behaviors among the four clients studied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional communication training with and without extinction and punishment. Fisher, W., Piazza, C., Cataldo, M., et al.[2018]

This study successfully demonstrated that caregivers can effectively conduct functional analyses and implement behavior interventions for a young man with developmental disabilities using an intensive telehealth model, indicating the potential for ABA therapy to be delivered remotely across different age groups.

Caregivers showed high adherence to the treatment procedures and reported the telehealth intervention as both acceptable and effective, suggesting that telehealth can be a viable option for delivering ABA services beyond traditional settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intensive telehealth assessment and treatment model for an adult with developmental disabilities. Shawler, LA., Clayborne, JC., Nasca, B., et al.[2021]

Functional communication training (FCT) is an effective evidence-based practice for addressing problem behaviors in individuals with developmental disabilities, as shown in a systematic review of 37 studies.

However, only six of these studies demonstrated successful maintenance and generalization of behavioral changes, indicating that additional strategies may be needed beyond the natural contingencies of FCT to sustain these improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generalization and maintenance of functional communication training for individuals with developmental disabilities: A systematic and quality review. Neely, L., Garcia, E., Bankston, B., et al.[2018]

Behavioral skills training (BST) effectively trained 13 behavior analysts to conduct functional analyses of problem behavior, demonstrating that remote training can be successful in a clinical setting.

All participants achieved mastery of the skills, with low error rates during in-situ probes, indicating that BST is a reliable method for teaching complex clinical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training behavior analysts to conduct functional analyses using a remote group behavioral skills training package. Lloveras, LA., Tate, SA., Vollmer, TR., et al.[2022]

Parent-implemented functional analyses (FAs) conducted at home with telehealth coaching successfully identified distinct behavioral functions for all four children with intellectual and developmental disabilities, demonstrating the efficacy of this approach.

In contrast, structured descriptive assessments (SDAs) conducted in the same setting only identified half of the functions found by the FAs, suggesting that FAs may provide more accurate insights into behavior when analyzed through antecedent-behavior and behavior-consequence relations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Agreement Between Structured Descriptive Assessments and Functional Analyses Conducted Over a Telehealth System. Martens, BK., Baxter, EL., McComas, JJ., et al.[2020]

The study involved three interventionist-child dyads, including a speech and language pathologist and two teaching assistants, who implemented functional communication training via telehealth to address challenging behaviors in children with autism spectrum disorder.

Despite interruptions due to COVID-19 school closures, the findings suggest that telehealth is an effective method for clinicians to collaborate with school staff in delivering behavioral assessments and interventions remotely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Brief Functional Analysis and Functional Communication Training Conducted Through Telehealth. Craig, EA., Dounavi, K., Ferguson, J.[2023]

Telehealth was effectively used to assess and initiate treatment for problem behavior in children with autism, demonstrating its potential as a viable service delivery method.

Parents were successfully coached to conduct functional analyses and implement functional communication training, resulting in an average reduction of problem behavior by 65.1%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evidence on the use of telehealth in an outpatient behavior clinic. Suess, AN., Wacker, DP., Schwartz, JE., et al.[2017]

Functional communication training (FCT) is recognized as a highly effective intervention for addressing severe behavior problems, based on extensive research since its introduction in 1985.

The review highlights the emergence of best practices in the FCT treatment process, which can enhance the development and implementation of effective interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional communication training: a review and practical guide. Tiger, JH., Hanley, GP., Bruzek, J.[2021]

Teaching parents to conduct functional analyses and implement functional communication training significantly reduced problem behaviors in children with autism across eight countries, demonstrating the efficacy of this approach.

The use of telehealth technologies for delivering these interventions was well-received by parents, who found the procedures acceptable and believed they would be effective for their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and acceptability of parent training via telehealth among families around the world. Tsami, L., Lerman, D., Toper-Korkmaz, O.[2020]

Telehealth technology effectively enabled parents to implement functional analysis and functional communication training for their children with developmental disabilities, leading to a reduction in self-injurious behavior and an increase in communication requests.

The study involved two families with boys diagnosed with cerebral palsy and autism spectrum disorder, and both families achieved a high fidelity of 95% in implementing the intervention with real-time remote coaching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coaching parents to assess and treat self-injurious behaviour via telehealth. Benson, SS., Dimian, AF., Elmquist, M., et al.[2023]

Functional communication training effectively reduced severe aggressive and self-injurious behaviors in two adult men with mental retardation, demonstrating its efficacy after years of less successful interventions.

The training not only led to behavior reduction but also generalized across different staff, environments, and tasks, highlighting its adaptability and potential as a safer alternative to aversive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing severe aggressive and self-injurious behaviors with functional communication training. Bird, F., Dores, PA., Moniz, D., et al.[2011]

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