Function-Based Intervention for Problem Behavior in Developmental Delay

Overseen By Stephanie Gerow, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Nevada, Las Vegas

Disqualifiers: None

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

Compensation: Varies

Number of Visits: 15

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new method to reduce problem behaviors in young children with developmental delays. The approach, called function-based assessment and intervention, teaches children alternative skills, such as communication, to replace challenging behaviors. Caregivers, including parents or grandparents, will receive training to use these techniques at home, supported by early intervention professionals. This trial suits children up to 5 years old who have developmental delays and frequently exhibit problem behaviors. As an unphased trial, it provides families with a unique opportunity to participate in innovative research that could enhance their child's development.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this function-based assessment and intervention is safe for children with developmental delay?

Research shows that the intervention used in this trial is generally safe and well-received by children with developmental delays. Studies have found that these methods can lead to positive outcomes, such as reducing problem behaviors and improving communication skills.

These strategies often help decrease problem behaviors by teaching children new ways to express themselves. The interventions focus on understanding why a child acts a certain way and then helping them learn better ways to meet their needs. This approach not only reduces unwanted behaviors but also promotes positive interactions.

Although specific data on negative effects is lacking, the intervention's nature, which involves teaching and positive reinforcement, suggests a low risk of harm. Overall, these interventions have shown promising results in safely supporting children with developmental challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this function-based intervention for addressing problem behavior in children with developmental delay because it empowers caregivers to actively participate in the treatment process. Unlike traditional therapies that may rely heavily on professional intervention, this approach teaches caregivers to implement strategies at home, promoting consistency and reinforcing positive behaviors in real-time. Additionally, the intervention focuses on replacing problem behaviors with effective communication skills, reducing the need for more restrictive or medication-based treatments. This hands-on, skill-building approach not only targets the root cause of the behavior but also strengthens the child's social-emotional abilities.

What evidence suggests that this function-based intervention is effective for reducing problem behavior in children with developmental delay?

Research has shown that specific assessments and treatments can help reduce problem behaviors in children with developmental delays. This trial will evaluate a function-based intervention, where caregivers implement strategies to teach children alternative, appropriate skills, such as communication, to replace problem behaviors. These methods have improved children's engagement in school and decreased problem behaviors. For example, these assessments help identify the reasons behind a child's behavior, allowing for more personalized and effective treatment. In one study with young children with autism, those who received these targeted treatments showed significant improvements. By teaching children new skills, like better communication, and rewarding these behaviors, caregivers can see a decrease in unwanted behaviors. Overall, evidence supports this approach as a promising way to address problem behaviors. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for caregivers of children aged birth to 5 years old who have developmental disabilities or delays and exhibit problem behaviors. Caregivers will implement procedures with guidance from professionals, and the child must be reported to have problem behavior by the caregiver or a professional.

Inclusion Criteria

Caregivers (e.g., parent, grandparent) of eligible child participants will participate with their child as the implementer of all procedures

An early intervention professional will participate with each caregiver-child dyad to coach the caregiver, in addition to the researcher.

Child has a developmental disability or delay based on caregiver report and/or receiving early intervention services

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline sessions with no intervention to observe problem behavior

2-4 weeks

Intervention

Function-based intervention implemented by the caregiver to teach alternative skills and reduce problem behavior

15 weeks

15 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Function-based assessment and intervention

Trial Overview

The study tests function-based assessment and intervention methods aimed at reducing problem behaviors in young children with developmental issues within IDEA Part C services. It's a single-case study assessing how effective these interventions are.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Following baseline (i.e., no intervention/business as usual) sessions, children will receive the intervention, consisting of a function-based intervention. This intervention will be implemented by the caregiver. The intervention will consist of teaching the child an alternative, appropriate skill (usually communication) to replace the problem behavior. The caregiver will provide reinforcement for the appropriate skill and no reinforcement (i.e., extinction) following problem behavior. The caregiver will also learn and use general strategies for teaching social-emotional skills (e.g., setting appropriate rules) as part of the intervention.

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials

81

Recruited

14,700+

Institute of Education Sciences

Collaborator

Trials

10

Recruited

3,200+

Published Research Related to This Trial

A new methodology was developed to assess the impact of adverse side effects (ASE) from psychotropic medications on challenging behavior in individuals with intellectual and developmental disabilities (IDD), involving seven participants.

The study found that most participants showed differences in their response rates under conditions designed to evaluate ASEs, indicating that these side effects can significantly influence behavior and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Side Effects of Psychotropic Medication and Challenging Behavior: Pilot Work Assessing Impact. Valdovinos, MG., Schieber, E., McMahon, M., et al.[2020]

A professional development package successfully trained three Head Start teachers to conduct trial-based functional analyses (TBFAs) with fidelity, allowing for effective assessment of challenging behaviors in the classroom.

The study found that a function-based intervention, derived from the TBFA results, led to significantly greater reductions in challenging behavior and increases in appropriate communication compared to a non-function-based intervention for all three children involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Accuracy of Results for Teacher Implemented Trial-Based Functional Analyses. Rispoli, M., Ninci, J., Burke, MD., et al.[2019]

A survey of 205 practitioners in Massachusetts revealed that while 67.8% believe functional analysis is the best tool for developing behavior plans, only 34.6% actually use it in practice.

Descriptive assessment was the most commonly used type of functional assessment among practitioners, indicating a gap between belief in the efficacy of functional analysis and its actual implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A statewide survey assessing practitioners' use and perceived utility of functional assessment. Roscoe, EM., Phillips, KM., Kelly, MA., et al.[2018]

The study demonstrated that function-based treatments, implemented by teachers and home providers in real-life settings, effectively reduced severe problem behaviors in two children with autism, such as self-injury and aggression.

Following the intervention, the children showed significant improvements in functional communication skills and compliance with adult instructions, indicating that the treatments not only addressed problem behaviors but also enhanced essential life skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Generality of Interview-Informed Functional Analyses: Systematic Replications in School and Home. Santiago, JL., Hanley, GP., Moore, K., et al.[2018]

A trial-based functional analysis (FA) was successfully implemented by three teachers with three boys who have developmental and intellectual disabilities, leading to the identification of behavior functions.

Five function-based interventions derived from the trial-based FAs effectively reduced problem behaviors and increased alternative behaviors, demonstrating the efficacy of this approach in managing challenging behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teacher-conducted trial-based functional analyses as the basis for intervention. Bloom, SE., Lambert, JM., Dayton, E., et al.[2019]

Functional assessment is crucial for understanding and addressing maladaptive behaviors, allowing for the development of treatments that promote positive, prosocial behaviors instead of relying on aversive methods.

Despite an increase in the use of functional assessment and skill training in treating aggression among individuals with developmental delays from 1979 to 1990, there was no corresponding decrease in the use of intrusive procedures, highlighting a need for better implementation of these methodologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between functional assessment and treatment selection for aggressive behaviors. Hile, MG., Desrochers, MN.[2019]

Trial-based functional analysis can effectively assess challenging behaviors in children with autism spectrum disorder in real educational settings, overcoming limitations of traditional functional analysis methods.

Individualized function-based interventions designed from trial-based analyses led to significant reductions in problem behaviors and increased classroom engagement for the students involved in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using trial-based functional analysis to design effective interventions for students diagnosed with autism spectrum disorder. Larkin, W., Hawkins, RO., Collins, T.[2019]

Functional assessment methods, such as direct observation and interviews, have greatly enhanced the effectiveness of behavioral treatments for problem behaviors in adults with mental retardation.

Functional analysis provides empirical evidence of behavioral functions in controlled settings, highlighting the importance of tailored assessment methods based on individual client needs and available resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional assessment of problem behaviors in adults with mental retardation. Paclawskyj, TR., Kurtz, PF., O'Connor, JT.[2011]

The study found that reinforcing spontaneous requests in children with autism can effectively reduce severe problem behavior, as parents provided the same rewards for both requests and problem behavior.

By reinforcing requests alongside problem behavior, children showed a preference for making requests, leading to a decrease in problem behavior, highlighting the potential for function-based treatments in managing behaviors in children with developmental disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased parent reinforcement of spontaneous requests in children with autism spectrum disorder: effects on problem behavior. Robertson, RE., Wehby, JH., King, SM.[2019]

Understanding the function of problem behaviors in individuals with intellectual disabilities is crucial for developing effective intervention plans, as recent studies confirm that success in reducing these behaviors is closely linked to this understanding.

Training nonprofessionals to conduct functional behavioral assessments has shown promise, indicating that effective behavioral interventions can be implemented even in challenging school settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional behavioural assessment in people with intellectual disabilities. Tassé, MJ.[2015]

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