Integrating Behavioral Treatment in Primary Care
Public ClinicalTrials.gov record NCT03658122. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study seeks to assess the usefulness of Parent-Child Care (PC-CARE), a brief behavioral intervention for children with difficult behaviors. It will test whether PC-CARE can help families who talk to their pediatricians about behavior problems by improving parent-child relationships, decreasing disruptive behaviors, and improving parents' knowledge and use of effective parenting strategies. Pediatricians who observe or are told their 2-10-year-old patients have difficult behaviors, such as aggression, disobedience, tantrums, trouble focusing, and/or angry and irritable behaviors, will refer patients to this study. At a first assessment, parents will complete questionnaires about the child's behaviors, parents and children will participate in a 12-minute play observation, and children will have their heart rate and blood flow measured during a 6-minute play observation. After this assessment, families will be randomly assigned either to begin PC-CARE right away or to wait about two months to begin PC-CARE. Those who begin right away will attend weekly one-hour appointments for six weeks. During appointments, parents and children report on difficult behaviors from the week, learn new positive communication, regulation, and behavior management skills, are observed during a 4-minute play observation, are coached to use the skills (i.e., have the therapist tell the parent how to use skills while interacting with the child), and discuss how to incorporate these skills at home. Parents and children are also asked to play together for five minutes daily at home. At the end of the six weeks, parents and children will complete the same assessments they did at the beginning. Those who wait to begin PC-CARE will be asked to complete the same questionnaires and observations again before beginning PC-CARE. They will then receive the same treatment as families who began PC-CARE right away. All families will be called one- and six- months after ending PC-CARE to complete a brief questionnaire about the child's behaviors. Main study hypotheses include: 1. Parents' positive communication with children will improve with PC-CARE 2. Parents will report less parenting stress after PC-CARE 3. Parents will report fewer child behavior problems after PC-CARE 4. Children will show lower stress reactivity (heart rate and blood flow) after PC-CARE 5. Parents will report similar levels of child behavior problems one- and six-months after completing PC-CARE
Study identification
- NCT ID
- NCT03658122
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 44 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 10 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 17, 2018
- Primary completion
- Sep 30, 2020
- Completion
- Mar 29, 2021
- Last update posted
- Apr 11, 2021
2018 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC Davis Children's Hospital | Sacramento | California | 95820 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03658122, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 11, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03658122 live on ClinicalTrials.gov.