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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06170047
Other study ID # R01HD105727
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 2, 2024
Est. completion date August 30, 2027

Study information

Verified date February 2024
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to test the effects of an evidence-based prevention intervention (CPP) adapted for foster and kinship caregivers of young children (FC; foster care) on caregiver competence and child behavior problems for children in foster care compared with an active comparator group that receives standard supports through the child welfare and healthcare systems (i.e., usual care).


Description:

The purpose of the study is to evaluate the impact of an evidence-based parenting program, The Chicago Parent Program (CPP) adapted for foster and kinship caregivers of young children (CPP-FC). A parallel, two-arm, randomized controlled trial of 300 caregiver-youth dyads will be conducted, comparing the impact of CPP-FC versus a usual care control on caregivers and foster youth. Quantitative and qualitative data about CPP-FC will be collected from foster and kinship caregivers and through observations of caregivers and youth. The findings from this study will demonstrate whether CPP-FC is effective in reducing behavior problems in young foster children and whether that contributes to reduced caregiver stress, increased caregiver confidence, increased positive parenting behavior, and longer lengths of time that children remain with foster and kinship caregivers, preventing unnecessary moves from one caregiver to another and improving child wellbeing.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 300
Est. completion date August 30, 2027
Est. primary completion date September 7, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Must be a licensed foster caregiver or kinship caregiver to a foster child between the ages of 2 and less than 9 years of age - Must be a licensed foster caregiver or kinship caregiver to a foster child in Ohio and in the custody of Hamilton County Job and Family Services, Butler County Children Services, or Montgomery County Children Services - Must be in good standing with the foster care agency - Must be English-speaking Exclusion Criteria: - Not having a foster child between the ages of 2 and less than 9 years - The foster child not being in the custody of Ohio counties: Hamilton County Job and Family Services, Butler County Children Services, or Montgomery County Children Services - The foster child was placed in the home more than 45 days prior to enrollment - The foster child being moved out of the placement prior to the start of the intervention - The foster child having been previously enrolled with another caregiver - The caregiver having been previously enrolled with another child - The caregiver unable to commit to completing all study activities - The foster child is not enrolled in the study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Chicago Parent Program for Foster Care
CPP-FC consists of 12 two-hour sessions delivered virtually by two trained group leaders over 16 weeks (11 concurrent weeks, 1 one-month booster) in a group-based format. Foster and kinship caregivers of young children are systematically taught parenting skills through group discussions, videotaped vignettes, structured role play and weekly homework assignments.
Other:
Usual Care
The Usual Care control will receive services from the county, CHECK clinic, and for licensed caregivers, their licensing agency per usual care. Caregivers receive training and support from their county and/or private licensing agency, children are referred to community services by the caseworker when behaviors emerge, and support from behavioral health specialists is available when caregivers request them.

Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (3)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati Johns Hopkins University, Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (8)

Alina Morawska, Matthew R Sanders, Divna Haslam, Ania Filus & Renee Fletcher (2014) Child Adjustment and Parent Efficacy Scale: Development and Initial Validation of a Parent Report Measure, Australian Psychologist, 49:4, 241-252, DOI: 10.1111/ap.12057

Berry, J. O., & Jones, W. H. (1995). The parental stress scale: Initial psychometric evidence. Journal of Social and Personal Relationships, 12, 463-472. http://dx.doi.org/10.1177/0265407595123009

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. — View Citation

Gibaud-Wallston J, Wandersman LP. Parenting Sense of Competence Scale. Lawrence Erlbaum Associates.; 1978. Accessed October 13, 2021. https://www.bristol.ac.uk/media-

Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015. — View Citation

Reid CA, Roberts LD, Roberts CM, Piek JP. Towards a model of contemporary parenting: the parenting behaviours and dimensions questionnaire. PLoS One. 2015 Jun 4;10(6):e0114179. doi: 10.1371/journal.pone.0114179. eCollection 2015. — View Citation

Research and Training DPICS-IV Manual (2013). PCIT. Accessed October 5, 2021. http://www.pcit.org/store/p19/Research_and_Training_DPICS-IV_Manual_%282013%29.html

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, Backus J. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. Ann Intern Med. 2017 Jul 4;167(1):63-65. doi: 10.7326/M17-1028. Epub 2017 Jun 6. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Parental Stress Scale The Parental Stress Scale is an 18-item questionnaire that assesses parental stress relating to parental sensitivity to the child, child behavior, and quality of the caregiver-child relationship. Items are rated on a 5-point scale, ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"). Some items are reverse scored. Items are summed to yield a total score, with higher scores indicating higher levels of parental stress. Baseline, 3 months (mid-point), and 6 months (follow-up)
Primary Change in Perceived Stress Scale The Perceived Stress Scale is a 14-item self-report measure of how unpredictable, uncontrollable, and overloaded individuals find their life circumstances. All items are rated on a 5-point scale, ranging from 0 ("Never") to 4 ("very often"). Some items are reverse scored. Responses are summed to yield a total score (range 0-56), with higher scores indicating greater perceived stress. Baseline, 3 months (mid-point), and 6 months (follow-up)
Primary The Child Adjustment & Parent Efficacy Scale, Total Intensity subscale The Child Adjustment & Parent Efficacy Scale, Total Intensity subscale is a 27-item measure of child behavior and emotional problems. Item responses are rated on a 4-point scale, ranging from 0 ("Not true of my child at all") to 3 ("True of my child very much"/"Most of the time"). Twenty-four items are summed to yield a Behavior Problems score (range 0-72), and three items are summed to yield an Emotional Problems score (range 0-9). Behavioral and Emotional Problems scores can be summed for a Total Intensity score (range 0-81). Higher scores indicate a higher level of problems. Baseline, 3 months (mid-point), and 6 months (follow-up)
Primary The Child Adjustment & Parent Efficacy Scale, Parenting Efficacy subscale The Child Adjustment & Parent Efficacy Scale, Parenting Efficacy subscale is a 19-item measure of parental self-efficacy. Item responses are rated on a 10-point scale, with responses ranging from 1 ("Certain I can't do it") to 10 ("Certain I can do it"). Items are summed to yield a total efficacy score, with higher scores indicating higher self-efficacy. Baseline, 3 months (mid-point), and 6 months (follow-up)
Primary Change in Parenting Sense of Competence Scale The Parenting Sense of Competence Scale is a 17-item questionnaire that measures overall parenting satisfaction and competence. Items are measured on a 6-point scale, with responses ranging from 1 ("Strongly disagree") to 6 ("Strongly agree"). Some items are reverse scored. Items are summed to yield two subscales: parental satisfaction and parental self-efficacy. Higher scores indicate higher levels of parental satisfaction and parental self-efficacy. Baseline, 3 months (mid-point), and 6 months (follow-up)
Secondary Change in Parenting Behaviors and Dimensions Questionnaire The Parenting Behaviors and Dimensions Questionnaire is a 33-item measure of contemporary parenting behavior that measures six core dimensions of parenting: Emotional Warmth, Punitive Discipline, Anxious Intrusiveness, Autonomy Support, Permissive Discipline, and Democratic Discipline. Items are rated on a 6-point scale ranging from 1 ("Never") to 7 ("Always"). Higher scores indicate higher levels of the parenting dimension. Baseline, 3 months (mid-point), and 6 months (follow-up)
Secondary Change in child behavior The Strengths and Difficulties Questionnaire is a 25-item questionnaire that assesses child behavior. Items are rated on a 3-point scale and responses range from 0 ("Not true") to 2 ("Certainly true"). Some items are reverse scored. Items are summed to yield 5 subscales: Emotional Problems, Conduct Problems, Hyperactivity, Peer Problems, and Prosocial. A total score is calculated using the sum of all the subscales, except Prosocial. Higher scores in each subscale and the total score indicate more child behavior problems. Baseline, 3 months (mid-point), and 6 months (follow-up)
Secondary Change in child self-regulation A 5-minute caregiver-child behavioral observation will be recorded and subsequently coded by two trained coordinators and the PI using is the Dyadic Parent-Child Interaction Coding System Comprehensive Manual for Research and Training 4th edition (DPICS-IV).91 The observation will involve a free-play period and a caregiver-directed clean-up from the play activity. The recording will be coded for caregiver positive statements (acknowledgment, description, unlabeled praise, labeled praise, reflection), statements to avoid (questions, indirect commands, negative talk), and direct commands. Child compliance, non-compliance, and instances where the child did not have the opportunity to comply with caregiver commands are also coded. Baseline and 3 months
Secondary Number of children experiencing placement change due to child behavior problems. The child welfare administrative record will be reviewed to assess number of child participants experiencing a placement change due to child behavior problems. 12 months
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