- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06771284
Problem Behavior Assessment and Intervention in IDEA Part C Services
January 20, 2026 updated by: Stephanie Gerow, University of Nevada, Las Vegas
Problem Behavior Assessment and Intervention in IDEA Part C Services: A Single-Case Study
The purpose of this study is to evaluate the effect of function-based assessment and intervention to reduce problem behavior in children with developmental disability or delay in the context of IDEA Part C services.
The investigators will conduct a single-case study to evaluate the efficacy of the intervention.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephanie Gerow, PhD
- Phone Number: 702-895-1109
- Email: stephanie.gerow@unlv.edu
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89154
- Recruiting
- University of Nevada Las Vegas
-
Contact:
- Stephanie Gerow, PhD
- Phone Number: 702-895-1109
- Email: stephanie.gerow@unlv.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Child Inclusion Criteria:
- age birth to 5 years old
- has a developmental disability or delay based on caregiver report and/or receiving early intervention services
- has problem behavior, as reported by the caregiver and/or early intervention professional
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Problem Behavior
Time Frame: The investigators plan to conduct approximately weekly observations, with a total of 15 observations.
|
The investigators will conduct 5-min observations and record the frequency of the child's problem behavior (e.g., aggression, self-injury, screaming) during each session.
The specific problem behavior(s) recorded will be defined individually by participant.
|
The investigators plan to conduct approximately weekly observations, with a total of 15 observations.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appropriate Behavior
Time Frame: The investigators plan to conduct approximately weekly observations, with a total of 15 observations.
|
The investigators will conduct 5-min observations and record the frequency of the child's appropriate behavior (e.g., communication) during each session.
The specific appropriate behavior(s) recorded will be defined individually by child participant.
|
The investigators plan to conduct approximately weekly observations, with a total of 15 observations.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
June 24, 2024
First Submitted That Met QC Criteria
January 9, 2025
First Posted (Actual)
January 13, 2025
Study Record Updates
Last Update Posted (Actual)
January 22, 2026
Last Update Submitted That Met QC Criteria
January 20, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Behavioral Symptoms
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Communication Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Child Behavior
- Problem Behavior
- Developmental Disabilities
- Learning Disabilities
- Investigative Techniques
- Methods
Other Study ID Numbers
- UNLV-2024-418
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.