NCT06771284

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Sep 2025May 2027

First Submitted

Initial submission to the registry

June 24, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

June 24, 2024

Last Update Submit

January 20, 2026

Conditions

Keywords

Early childhoodProblem behaviorHome-based servicesIDEA Part C services

Outcome Measures

Primary Outcomes (1)

  • Problem Behavior

    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 Outcomes (1)

  • Appropriate Behavior

    The investigators plan to conduct approximately weekly observations, with a total of 15 observations.

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: Function-based assessment and intervention

Interventions

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.

Intervention

Eligibility Criteria

Age0 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

RECRUITING

MeSH Terms

Conditions

Problem BehaviorLearning DisabilitiesDevelopmental Disabilities

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild BehaviorCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Stephanie Gerow, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The investigators will use a multiple baseline design across participants with a baseline and intervention phase to evaluate the effects of the intervention on children's challenging behavior. Each of the 3 tiers of the multiple baseline will include a caregiver-child dyad. One early intervention professional will work with each caregiver-child dyad, for a total of 9 participants across 3 tiers.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 24, 2024

First Posted

January 13, 2025

Study Start

September 30, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations