Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems (PriCARE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02778022|
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment|
|Child Behavior Disorders||Behavioral: PriCARE|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Immediate PriCARE
Parent-child dyads assigned to the immediate PriCARE group will receive the PriCARE intervention as soon as possible plus usual treatment. The intervention will last approximately 6-8 weeks. Each group will have 4-13 participants and 2 facilitators and will meet 6 times for 1-2 hours per session. Parents are expected to practice the skills they learn with their children between sessions.
PriCARE is a group parent training program designed to improve child behavior, improve parent-child relationships, and decrease stress for parents. PriCARE utilizes the 3 P skills (Praise, Paraphrase and Point-out-Behavior) and includes a trauma and stress education component. The training starts with parenting skills focused on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second phase of the training teaches techniques for giving children effective commands in order to set age-appropriate limits. We piloted PriCARE and demonstrated promising findings. The PriCARE intervention has been slightly modified from the pilot version to increase engagement and attendance.
Other Name: Child Adult Relationship Enhancement in Pediatric Primary Care
No Intervention: Delayed PriCARE
The delayed PriCARE group will not receive the PriCARE intervention until data collection for this study is complete (in 3-6 months). In addition, they will be immediately offered usual treatment. Under usual treatment, patients will be referred to a behavioral health specialist at the discretion of their pediatrician and the office social worker for additional diagnosis and treatment and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual.
- Change in Eyberg Child Behavior Inventory (ECBI) score between baseline and time 3. [ Time Frame: baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3) ]The primary objective of this study is to determine if the modified PriCARE program decreases the intensity and frequency of behavior problems in 2- to 6-year-old children as measured by the change in ECBI score after 3-7 months compared to usual treatment for child behavior problems at CHOP's South Philadelphia Primary Care Center or Karabots Pediatric Care Center. As sub-analyses, we will determine 1) the impact of caregiver depression (as measured by the Brief Symptom Inventory, BSI) on the efficacy of PriCARE intervention to decrease behavioral problems and 2) the impact of the number of PriCARE sessions attended on the efficacy of the PriCARE intervention to decrease behavioral problems.
- Change in Adult Adolescent Parenting Inventory-2 (AAPI-2) score between baseline and time 3 [ Time Frame: baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3) ]We will assess the efficacy of the modified PriCARE on decreasing harsh parenting as measured by the AAPI-2.
- Change in Parenting Stress Index (PSI) score between baseline and time 3 [ Time Frame: baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3) ]We will assess the efficacy of the modified PriCARE on decreasing parenting stress as measured by the PSI.
- Association between the Therapeutic Attitude Inventory (TAI) score and the change in ECBI score from baseline to time 2 and 3 in the immediate PriCARE group. [ Time Frame: 14-27 weeks (time 3) ]We will assess parents' perceptions of the efficacy of the modified PriCARE on improving parenting skills and child behavior as measured by the TAI.
- Conceptual model of facilitators and barriers to participation in behavioral interventions in primary care as well as the strengths and weaknesses of the PriCARE program [ Time Frame: 6-27 weeks ]We will conduct a qualitative interview with up to 20 parents randomized to the immediate PriCARE group to gain an understanding of how implementation and dissemination of the modified PriCARE can be improved in order to increase attendance and maximize effectiveness.
- Change in The Keys to Interactive Parenting Scale (KIPS) score between baseline and time 3 [ Time Frame: baseline (time 1) and 14-27 weeks (time 3) ]As an exploratory aim, we will pilot the use of a video observation measure of parent-child interaction (KIPS) in assessing the impact of PriCARE on parenting behaviors with a subset of subjects.
- Description of study groups [ Time Frame: baseline ]Demographics and baseline measures of child behavior (ECBI), parent intimate partner violence (HITS), and parent depression (BSI) for the intervention and control groups will be examined to ensure randomization resulted in comparable populations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778022
|Contact: Joanne N Wood, MD, MSHPemail@example.com|
|Contact: Christine W Paine, MPHfirstname.lastname@example.org|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Joanne N Wood, MD, MSHP 267-426-3107 email@example.com|
|Contact: Christine W Paine, MPH 267-426-0369 firstname.lastname@example.org|
|Sub-Investigator: Philip V Scribano, DO, MSCE|
|Sub-Investigator: Steven Berkowitz, MD|
|Principal Investigator:||Joanne N Wood, MD, MSHP||Children's Hospital of Philadelphia|