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PriCARE for Parent-Child Relationship (PriCARE Trial)

N/A
Waitlist Available
Led By Joanne Wood, MD, MSHP
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child is 2-6 years old
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8-17 weeks (time 2), 16-30 weeks (time 3)
Awards & highlights

PriCARE Trial Summary

This trial will test whether an intervention can help parents, decrease child behavior problems, and reduce the risk of maltreatment.

Eligible Conditions
  • Parent-Child Relationship
  • Problematic Behavior

PriCARE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The child is between 2 and 6 years of age.

PriCARE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-17 weeks (time 2), 16-30 weeks (time 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-17 weeks (time 2), 16-30 weeks (time 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Parenting Scale (PS) score from time 1 to time 2
Secondary outcome measures
Change in the Child Abuse Potential Inventory (CAPI) score from time 1 to time 2
Change in the Dyadic Parent-Child Interaction Coding (DPICS) score from time 1 to time 2
Change in the Eyberg Child Behavior Inventory (ECBI) score from time 1 to time 2
+1 more
Other outcome measures
Change in the Child Abuse Potential Inventory (CAPI) score from baseline to time 2 to time 3
Change in the Dyadic Parent-Child Interaction Coding (DPICS) score from time 2 to time 3
Change in the Eyberg Child Behavior Inventory (ECBI) score from time 2 to time 3
+2 more

PriCARE Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Immediate PriCARE Positive Discipline ModuleExperimental Treatment1 Intervention
A subset of participants (up to 40 caregiver-child pairs) who were assigned to the immediate PriCARE group will be offered to participate in the PriCARE Positive Discipline Module if they attended at least 4 PriCARE sessions and completed both main study interviews. If they are randomized to the immediate PriCARE Positive Discipline group, they will attend an additional 4-6 sessions 4-6 weeks after completion of the 6-week PriCARE intervention. This module teaches techniques related to behavior reward charts, appropriate timeout protocol, and other positive discipline techniques for handling persistent behaviors not addressed by the other PriCARE skills.
Group II: Immediate PriCAREExperimental Treatment1 Intervention
Caregiver-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 approximately 4-13 participants and 1-2 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.
Group III: Delayed PriCAREActive Control1 Intervention
The delayed PriCARE group will not receive the PriCARE intervention until after their 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.
Group IV: Delayed PriCARE Positive Discipline ModuleActive Control1 Intervention
The delayed Positive Discipline group will not receive the Positive Discipline Module intervention until after their third interview data collection is complete (in 2-3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PriCARE
2016
N/A
~440
Positive Discipline Module
2019
N/A
~240

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
705 Previous Clinical Trials
8,571,202 Total Patients Enrolled
Annie E. Casey FoundationOTHER_GOV
5 Previous Clinical Trials
1,402 Total Patients Enrolled
The Pew Charitable TrustsOTHER
3 Previous Clinical Trials
2,821 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study currently enrolling participants?

"Affirmative. According to clinicaltrials.gov, the study which was first posted on December 3rd 2019 is actively seeking participants. This medical trial requires 238 patients from a single site and has been updated most recently on April 4th 2022."

Answered by AI

What are the eligibility criteria for participation in this trial?

"This clinical trial is enrolling 238 parent-child duos, aged 2 to 6 years old. In order to qualify for participation, caregivers must meet the following conditions: be 18 or older; converse in English fluently; possess legal guardianship of their child and provide informed consent; own a mobile device capable of receiving text messages; attend scheduled PriCARE sessions when possible; have access to one of CHOP's Pennsylvania primary care sites or either UNC location (Children's Primary Care/Pediatrics at Panther Creek); and the appropriate technological tools necessary for remote engagement where onsite attendance isn't feasible."

Answered by AI

Is this experimental research recruiting elderly individuals as participants?

"Patients must be between two and six years of age in order to qualify for this trial. There are 95 studies available for underage individuals, while 90 can be found that cater to seniors aged 65 or older."

Answered by AI

To what extent is this research endeavor being actively pursued by participants?

"Affirmative. The trial, which was announced on December 3rd 2019 and most recently updated April 4th 2022, is actively seeking participants. At present there are 238 openings at a single clinical site."

Answered by AI
Recent research and studies
~45 spots leftby Mar 2025