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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03910491
Other study ID # 18-015677
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 16, 2019
Est. completion date December 31, 2023

Study information

Verified date May 2023
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Children in foster care have disproportionately high rates of mental and behavioral health concerns. Foster caregivers have reported challenges managing such difficult behaviors. Such behaviors are associated with placement instability. Child Adult Relationship Enhancement (CARE), an evidence-based positive parenting intervention, has shown promising findings in the primary care setting and its curriculum has been enhanced (PriCARE). This positive parenting intervention offers a promising strategy to provide foster caregivers with the skills needed to address these behavioral problems. The objectives of this study are 1) to evaluate the acceptability and feasibility of PriCARE, a positive parenting intervention, in the foster care setting 2) to assess the efficacy of PriCARE to promote positive parenting, increase empathy among foster caregivers, and improve parenting efficacy and satisfaction and 3) to identify best practices for implementation and dissemination of PriCARE in the foster care setting. Foster caregivers of foster children 2-10 years of age in the Philadelphia child welfare system will be enrolled in this study. Foster caregivers must be English-speaking and age 18 years or older. Foster caregivers will be recruited from the Children's Hospital of Philadelphia (CHOP) Fostering Health Program, CHOP primary care sites, CHOP Safe Place Care Clinics, direct referrals from social workers and medical providers, and from referrals from Philadelphia foster care agencies and organizations. Forty-five foster caregivers will be enrolled in the study and will be assigned to the enhanced PriCARE program. Each approximately 9 hour CARE training group will be attended by approximately 4-12 foster caregivers without their children. An initial interview will be conducted prior to initiation of the PriCARE program and will include measures to obtain baseline data regarding demographic information, parenting attitudes and parenting strategies. A second interview will be conducted 4-10 weeks after PriCARE program completion and will include a semi-structured qualitative interview as well as measures of parenting attitudes and parenting strategies.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Foster caregiver is age 18 years or older 2. Caregiver is a foster parent of a foster child between 2 and 10 years of age 3. English-speaking 4. Foster caregiver provides informed consent Exclusion Criteria: 1) Foster caregivers who have previously completed CARE or PriCARE training.

Study Design


Intervention

Behavioral:
PriCARE
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.

Locations

Country Name City State
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Ray E. Helfer Society

Country where clinical trial is conducted

United States, 

References & Publications (8)

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

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. — View Citation

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. — View Citation

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

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.

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

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Other Description of study groups General demographic information will be collected during the baseline interview for the foster caregiver. baseline (pre-intervention)
Primary Number of participants enrolled in PriCARE intervention Foster caregiver enrollment in the intervention will be measured follow-up (6 wks post-intervention)
Primary Rate of participant attendance to PriCARE training sessions Attendance to number of sessions will be measured follow-up (6 wks post-intervention)
Primary Retention rate of participants in PriCARE Retention in the PriCARE intervention will be measured follow-up (6 wks post-intervention)
Secondary Change in Adult-Adolescent Parenting Inventory-2 (AAPI-2) score between baseline and follow-up visit Assess the efficacy of PriCARE on decreasing harsh parenting and increasing parental empathy as measured by the AAPI-2. The AAPI-2 is a 40-item self-report measure using a 5 point scale. Responses are converted to stem scores that compare the participant's response to a normal distribution and determine if responses indicate high, average, or low risk for maltreatment of children. Scores of 1 through 4 identify a risk of abusive parenting behaviors, scores of 5 or 6 are considered average, and scores from 7 through 10 indicate nurturing parental attitudes. baseline (pre-intervention) and follow-up (4-10 wks post-intervention)
Secondary Change in Parenting Scale score between baseline and follow-up visit Assess the efficacy of PriCARE on decreasing harsh parenting as measured by the Parenting Scale. The Parenting Scale is a 30-item self-report questionnaire that was designed to assess dysfunctional parenting discipline strategies. Parents choose their response to various situations using a likert scale. Higher scores indicate ineffective parenting strategies. baseline (pre-intervention) and follow-up (4-10 wks post-intervention)
Secondary The change in Parenting Sense of Competence score between baseline and follow-up visit Assess the efficacy of PriCARE on improving parenting satisfaction and efficacy as measured by the Parenting Sense of Competence scale. The Parenting Sense of Competence Scale is a 17-item self-report questionnaire that assesses parenting competence in two dimensions - parenting satisfaction and parenting efficacy using a 6-point scale ranging from "strongly disagree" to "strongly agree." Higher scores indicate higher parenting self-esteem. baseline (pre-intervention) and follow-up (4-10 wks post-intervention)
Secondary Therapeutic Attitude Inventory (TAI) score The investigators will use the TAI score to evaluate foster caregiver perceptions on the efficacy of the PriCARE intervention as measured by the Therapeutic Attitudes Inventory (TAI). The Therapeutic Attitude Inventory (TAI) is a brief 10 question satisfaction measure of parent training and parent-child treatments. Higher scores indicate greater satisfaction with the intervention. follow-up (4-10 wks post-intervention)
Secondary Understanding foster caregiver perspectives on parenting and the impact of the PriCARE intervention on their parenting through qualitative interviews A brief semi-structured interview will be conducted during first interview to understand foster caregiver's motivations and attitudes of foster parenting. At the follow-up visit, a more in-depth individual semi-structured interview will be conducted in order to understand foster caregiver's perspectives of their role as a foster parent, their relationship with their foster child, their perceived stress, and their perspectives on the PriCARE intervention and strategies for improving it. baseline (pre-intervention) and follow-up (4-10 wks post-intervention)
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