- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520331
Using the Adaptive Behavioral Counseling Decision Framework to Guide Single-Session Intervention for Preschool Behavioral Concerns in Pediatric Primary Care: A Feasibility Trial (ABD-DeF)
Adaptive Behavioral Counseling Decision Framework in Pediatric Primary Care
The goal of this clinical trial is to evaluate the feasibility, acceptability, and initial effectiveness of using the Adaptive Behavioral Counseling Decision Framework to provide behavioral counseling for common preschool behavior problems in pediatric primary care. The interventions will be provided by integrated behavioral health clinicians and provided to primary caregivers of children aged 18-65 months who screen positive on the Preschool Pediatric Symptom Checklist (PPSC) or otherwise identify a child behavior concern. Participants will receive behavioral guidance based on the Adaptive Behavioral Counseling Decision Framework during their child's medical visit or a single behavioral health visit. The main question[s] it aims to answer are:
- What is the feasibility and acceptability of using a decision framework to guide selection and delivery of a single-session intervention for early childhood behavior concerns in pediatric primary care?
- What is the initial effectiveness of framework-guided brief interventions in reducing parent-reported behavior concerns based on caregiver report?
The hypotheses are that the intervention will be delivered with fidelity in the time allotted, and that caregivers will rate the intervention as feasible and acceptable.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrew Riley, PhD
- Phone Number: 503-494-1724
- Email: rileyand@ohsu.edu
Study Contact Backup
- Name: Cassidy McDermott, PhD
- Email: mcdermott@ohsu.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Caregivers of children ages 18-65 months who screen positive on the Preschool Pediatric Symptom Checklist (PPSC) or otherwise identify a child behavior concern.
- Caregivers must be at least 18 years old.
- Caregivers must speak English or Spanish sufficiently to complete study procedures. Study procedures in other languages are not feasible.
Exclusion Criteria:
- Children with moderate to severe intellectual disabilities.
- Child and caregiver are already receiving more intensive behavioral parent training intervention (either at OHSU or in the community).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adaptive Behavioral Counseling Decision Framework
The Adaptive Behavioral Counseling Decision Framework consists of a series of dichotomous questions about the nature of the child's behavior, which then indicate which brief behavioral intervention is likely to be most appropriate.
The possible brief interventions include scheduled parent-child play, giving effective instructions, differential attention, strategic ignoring, specific praise, use of rewards, and time-out.
Each of these behavioral interventions are strategies that are included in several well-established parenting treatment programs.
|
The intervention components are common elements of evidence-based parenting interventions.
In this study, they are distinguished by their delivery in the context of a single behavioral health consultation (about 20 minutes) during a pediatric health care visit.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Acceptability Survey
Time Frame: Immediate post-intervention and 30-day follow-up
|
11-item, study-specific survey evaluating participants acceptance of the intervention.
Each item is on a 4-point scale and total scores range from 11-44 with lower scores indicating higher acceptability.
|
Immediate post-intervention and 30-day follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Top Problems Assessment
Time Frame: Baseline and 30-day follow-up
|
The Top Problems Assessment is a brief instrument to identify and monitor caregivers' top behavioral concerns.
Caregivers may identify between 1-3 problems.
The severity of each problem is rated from 0 (not a problem) to 4 (a very big problem).
|
Baseline and 30-day follow-up
|
|
Preschool Pediatric Symptom Checklist
Time Frame: Baseline and 30-day follow-up
|
The Preschool Pediatric Symptom Checklist (PPSC) is an 18-item validated screening tool used by caregivers to assess emotional and behavioral problems in children aged 18 to 65 months.
Each item is on a 0-2 point scale, with a total possible range of 0-36, with higher scores indicating more severe problems.
|
Baseline and 30-day follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andrew R Riley, PhD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00029462
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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