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NCT Number: NCT07520331

Using the Adaptive Behavioral Counseling Decision Framework to Guide Single-Session Intervention for Preschool Behavioral Concerns in Pediatric Primary Care: A Feasibility Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Adaptive Behavioral Counseling Decision Framework

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Riley, PhD

CONTACT

[email protected]

503-494-1724

Cassidy McDermott, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Adaptive Behavioral Counseling Decision Framework in Pediatric Primary Care

Acronym: ABD-DeF

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.