NCT03658122

Integrating Behavioral Treatment in Primary Care

Completed NA Last updated 12 April 2021

What this trial tests

NA trial testing Parent-Child Care in Problem;Behaviour;Child in 44 participants. Completed in 30 March 2021.

Timeline

18 September 2018

Primary endpoint
1 October 2020

30 March 2021

Quick facts

Lead sponsor	University of California, Davis
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	44
Start date	18 September 2018
Primary completion	1 October 2020
Estimated completion	30 March 2021
Sites	1 location across United States

Drugs / interventions tested

• Parent-Child Care

Conditions studied

• Problem;Behaviour;Child — all drugs for Problem;Behaviour;Child →
• Parent-Child Relations — all drugs for Parent-Child Relations →

Sponsor

University of California, Davis

Who can join

Adults 2 to 10, any sex, with Problem;Behaviour;Child or Parent-Child Relations. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.