NCT03910491

Brief Summary

The purpose of the study is to evaluate early implementation outcomes of a positive parenting program, Child Adult Relationship Enhancement in Primary Care (PriCARE), in the foster care setting and to assess the efficacy of PriCARE in promoting positive parenting and increasing empathy among foster caregivers.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

April 16, 2019

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

6.7 years

First QC Date

April 5, 2019

Last Update Submit

May 13, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of participants enrolled in PriCARE intervention

    Foster caregiver enrollment in the intervention will be measured

    follow-up (6 wks post-intervention)

  • Rate of participant attendance to PriCARE training sessions

    Attendance to number of sessions will be measured

    follow-up (6 wks post-intervention)

  • Retention rate of participants in PriCARE

    Retention in the PriCARE intervention will be measured

    follow-up (6 wks post-intervention)

Secondary Outcomes (5)

  • Change in Adult-Adolescent Parenting Inventory-2 (AAPI-2) score between baseline and follow-up visit

    baseline (pre-intervention) and follow-up (4-10 wks post-intervention)

  • Change in Parenting Scale score between baseline and follow-up visit

    baseline (pre-intervention) and follow-up (4-10 wks post-intervention)

  • The change in Parenting Sense of Competence score between baseline and follow-up visit

    baseline (pre-intervention) and follow-up (4-10 wks post-intervention)

  • Therapeutic Attitude Inventory (TAI) score

    follow-up (4-10 wks post-intervention)

  • Understanding foster caregiver perspectives on parenting and the impact of the PriCARE intervention on their parenting through qualitative interviews

    baseline (pre-intervention) and follow-up (4-10 wks post-intervention)

Other Outcomes (1)

  • Description of study groups

    baseline (pre-intervention)

Study Arms (1)

Intervention

EXPERIMENTAL

All participants who enroll in the study will be assigned to a PriCARE group program that will adhere to the approximately 9 hour PriCARE curriculum.The trainings are administered to groups of approximately 4-12 caregivers at a time and are led by 2 mental health providers trained in the PriCARE curriculum. The curriculum will be delivered in 2-6 sessions over a 2-20 week period.

Behavioral: PriCARE

Interventions

PriCAREBEHAVIORAL

PriCARE is a group parent training program designed to improve child behavior, improve parent-child relationships, and decrease stress for parents. PriCARE emphasizes the 3 Ps (Praise, Paraphrase, and Point-out-Behavior). The training initially focuses on parenting skills including giving attention to the child's positive behaviors and ignoring minor misbehaviors. The second phase of training includes teaching techniques for giving children effective commands to set age-appropriate limits. The PriCARE curriculum also includes trauma and stress education components in order to contextualize the use of these skills with the types of behaviors and problems demonstrated by many children who have experienced psychosocial adversity and chronic familial stress. Throughout the curriculum, caregivers are encouraged to practice the skills. PriCARE has been evaluated in the primary care setting and has shown promise. There have been limited studies on PriCARE for foster caregivers.

Also known as: Child Adult Relationship Enhancement in Pediatric Primary Care
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Foster caregiver is age 18 years or older
  • Caregiver is a foster parent of a foster child between 18 months and 6 years of age
  • English-speaking
  • Foster caregiver provides informed consent

You may not qualify if:

  • \) Foster caregivers who have previously completed CARE or PriCARE training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (8)

  • Gurwitch RH, Messer EP, Masse J, Olafson E, Boat BW, Putnam FW. Child-Adult Relationship Enhancement (CARE): An evidence-informed program for children with a history of trauma and other behavioral challenges. Child Abuse Negl. 2016 Mar;53:138-45. doi: 10.1016/j.chiabu.2015.10.016. Epub 2015 Nov 22.

    PMID: 26613674BACKGROUND
  • Wood JN, Dougherty SL, Long J, Messer EP, Rubin D. A Pilot Investigation of a Novel Intervention to Improve Behavioral Well-Being for Children in Foster Care. Journal of Emotional and Behavioral Disorders. 2017

    BACKGROUND
  • Schilling S, French B, Berkowitz SJ, Dougherty SL, Scribano PV, Wood JN. Child-Adult Relationship Enhancement in Primary Care (PriCARE): A Randomized Trial of a Parent Training for Child Behavior Problems. Acad Pediatr. 2017 Jan-Feb;17(1):53-60. doi: 10.1016/j.acap.2016.06.009. Epub 2016 Jun 25.

    PMID: 27353449BACKGROUND
  • Conners NA, Whiteside-Mansell L, Deere D, Ledet T, Edwards MC. Measuring the potential for child maltreatment: the reliability and validity of the Adult Adolescent Parenting Inventory--2. Child Abuse Negl. 2006 Jan;30(1):39-53. doi: 10.1016/j.chiabu.2005.08.011. Epub 2006 Jan 6.

    PMID: 16406026BACKGROUND
  • Arnold DS, O'Leary SG, Wolff LS, Acker MM. The Parenting Scale: A measure of dysfunctional parenting in discipline situations. Psychological Assessment. 1993;5(2):137-44. doi: 10.1037/1040-3590.5.2.137

    BACKGROUND
  • Karazsia B, Dulmen M, Wildman B. Confirmatory Factor Analysis of Arnold et al.'s Parenting Scale Across Race, Age, and Sex. Journal of Child & Family Studies. 2008;17(4):500-16. doi: 10.1007/s10826-007-9170-1. PubMed PMID: 32587293

    BACKGROUND
  • Ohan JL, Leung DW, Johnston C. The Parenting Sense of Competence scale: Evidence of a stable factor structure and validity. Canadian Journal of Behavioural Science/Revue canadienne des sciences du comportement. 2000;32(4):251

    BACKGROUND
  • Messer, E. P., Greiner, M. V., Beal, S. J., Eismann, E. A., Cassedy, A., Gurwitch, R. H., Boat, B.W., Bensman, H., Bemerer, J., Hennigan, M. & Greenwell, S. (2018). Child adult relationship enhancement (CARE): A brief, skills-building training for foster caregivers to increase positive parenting practices. Children and Youth Services Review, 90, 74-82.

    BACKGROUND

MeSH Terms

Conditions

Child Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Joanne N Wood, MD, MSHP

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne Wood, MD, MSHP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 10, 2019

Study Start

April 16, 2019

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations