Early Childhood Emotional and Behavioral ConcernsABD-DeFNCT07520331
Using the Adaptive Behavioral Counseling Decision Framework to Guide Single-Session Intervention for Preschool Behavioral Concerns in Pediatric Primary Care: A Feasibility Trial
A study testing Adaptive Behavioral Counseling Decision Framework in people with Early Childhood Emotional and Behavioral Concerns, run by Oregon Health and Science University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Childhood Emotional and Behavioral Concerns
- What is being tested?
- Adaptive Behavioral Counseling Decision Framework
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Cassidy McDermott, PhD contact
About this study
Official title: 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.
- Being tested
- Adaptive Behavioral Counseling Decision Framework
- Keywords
- primary care, integrated behavioral health, pediatrics, early childhood, feasibility trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Behavioral Counseling Decision FrameworkBehavioural
Also called effective instruction delivery, praise, rewards, time-out
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.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Behavioral Counseling Decision Framework | Experimental | 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. Receives: Behavioral: Adaptive Behavioral Counseling Decision Framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability Survey
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.
Measured: Immediate post-intervention and 30-day follow-up
Secondary outcomes (2)
Top Problems Assessment
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).
Measured: Baseline and 30-day follow-up
Preschool Pediatric Symptom Checklist
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.
Measured: Baseline and 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood Emotional and Behavioral ConcernsStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Riley, Oregon Health and Science University
- Investigators
- Andrew R Riley, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520331
- Sponsor's protocol ID
- STUDY00029462
- Acronym
- ABD-DeF
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available from the PI upon request .
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Behavioral Counseling Decision Framework in Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT07520331
- Acronym / sponsor ID
- ABD-DeF / STUDY00029462
- Keywords
- primary care, integrated behavioral health, pediatrics, early childhood, feasibility trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 9 Apr 2026 (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 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Behavioral Counseling Decision Framework | Experimental | Behavioral: Adaptive Behavioral Counseling Decision FrameworkThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
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 |
|---|---|---|
| Adaptive Behavioral Counseling Decision FrameworkAlso: effective instruction delivery, praise, rewards, time-outThe 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. | Behavioural | Adaptive Behavioral Counseling Decision Framework |
Primary outcome
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.
2 secondary outcomes
Top Problems Assessment
Time frame: Baseline and 30-day follow-up
Preschool Pediatric Symptom Checklist
Time frame: Baseline and 30-day follow-up
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 9 Apr 2026.
- Individual participant dataSharing planned: Yes. Data will be available from the PI upon request .
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.
Cassidy McDermott, PhD contact
Andrew R Riley, PhD principal investigator
Oregon Health and Science University
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Behavioral Counseling Decision Framework in people with Early Childhood Emotional and Behavioral Concerns, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Andrew Riley, PhD (503-494-1724, rileyand@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Acceptability Survey (time frame: Immediate post-intervention and 30-day follow-up). 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 9 Apr 2026.