Problem BehaviorNCT06771284
Problem Behavior Assessment and Intervention in IDEA Part C Services
A study testing Function-based assessment and intervention in people with Problem Behavior and Developmental Delay, run by University of Nevada, Las Vegas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Problem Behavior, Developmental Delay, Developmental Disability
- What is being tested?
- Function-based assessment and intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nevada Las Vegas
Las Vegas, Nevada, 89154
Stephanie Gerow, PhD, 702-895-1109, stephanie.gerow@unlv.edu
About this study
Official title: 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.
- Being tested
- Function-based assessment and intervention
- Keywords
- Early childhood, Problem behavior, Home-based services, IDEA Part C services
- Medical subject headings
- Problem Behavior, Learning Disabilities, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Function-based assessment and interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Function-based assessment and intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The investigators plan to conduct approximately weekly observations, with a total of 15 observations.
Secondary outcomes (1)
Appropriate Behavior
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.
Measured: The investigators plan to conduct approximately weekly observations, with a total of 15 observations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start30 Sep 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Education Sciences
- Responsible party
- Principal investigator, Stephanie Gerow, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771284
- Sponsor's protocol ID
- UNLV-2024-418
- Status last verified
- Jan 2026
- First submitted
- 24 Jun 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem Behavior Assessment and Intervention in IDEA Part C Services: A Single-Case Study
- ClinicalTrials.gov ID
- NCT06771284
- Acronym / sponsor ID
- UNLV-2024-418
- Keywords
- Early childhood, Problem behavior, Home-based services, IDEA Part C services
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Collaborators
- Institute of Education Sciences
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Function-based assessment and interventionFollowing 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 may qualify
- Ages
- 0 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Function-based assessment and interventionThis 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. | Behavioural | Intervention |
Primary outcome
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.
1 secondary outcome
Appropriate Behavior
Time frame: The investigators plan to conduct approximately weekly observations, with a total of 15 observations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Function-based assessment and intervention in people with Problem Behavior and Developmental Delay, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Gerow, PhD (702-895-1109, stephanie.gerow@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Problem Behavior (time frame: The investigators plan to conduct approximately weekly observations, with a total of 15 observations.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.