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)

April 3, 2026 updated by: Andrew Riley, Oregon Health and Science University

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

Study Type

Interventional

Enrollment (Estimated)

60

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

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

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: 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:
  • effective instruction delivery
  • praise
  • rewards
  • time-out
  • differential attention
  • strategic ignoring
  • scheduled play

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andrew R Riley, PhD, Oregon Health and Science University

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available from the PI upon request .

IPD Sharing Time Frame

5 years from the end of the study.

IPD Sharing Access Criteria

Anonymized data will be available from the PI upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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