NCT06170047

Brief 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).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Feb 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Feb 2024Aug 2027

First Submitted

Initial submission to the registry

November 27, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 2, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2026

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

November 27, 2023

Last Update Submit

March 18, 2026

Conditions

Keywords

Foster careChild behaviorParenting skillsBehavioral healthPreventionParenting confidenceParenting stress

Outcome Measures

Primary Outcomes (5)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (4)

  • Change in Parenting Behaviors and Dimensions Questionnaire

    Baseline, 3 months (mid-point), and 6 months (follow-up)

  • Change in child behavior

    Baseline, 3 months (mid-point), and 6 months (follow-up)

  • Change in child self-regulation

    Baseline and 3 months

  • Number of children experiencing placement change due to child behavior problems.

    12 months

Study Arms (2)

Chicago Parent Program for Foster Care

EXPERIMENTAL

The Chicago Parent Program for Foster Care (CPP-FC) is a caregiver-directed prevention program to strengthen parenting skills and confidence in foster and kinship caregivers and prevent or reduce behavior problems in children 2-8 years old. CPP-FC was designed to specifically meet the unique needs of children ages 2-8 who are placed with foster and kinship caregivers. Participants assigned to CPP-FC will receive CPP-FC and the services typically offered from the county, Cincinnati Children's Hospital Medical Center Comprehensive Health Evaluations for Cincinnati's Kids (CHECK) clinic, and for licensed caregivers, their licensing agency.

Behavioral: Chicago Parent Program for Foster Care

Usual Care

ACTIVE COMPARATOR

Usual Care control will receive standard care offered from the county, Cincinnati Children's Hospital Medical Center Comprehensive Health Evaluations for Cincinnati's Kids (CHECK) clinic, and for licensed caregivers, their licensing agency.

Other: Usual Care

Interventions

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.

Also known as: CPP-FC, Caregivers on Point
Chicago Parent Program for Foster 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.

Usual Care

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Related Publications (9)

  • 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

    BACKGROUND
  • 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.

    PMID: 6668417BACKGROUND
  • Gibaud-Wallston J, Wandersman LP. Parenting Sense of Competence Scale. Lawrence Erlbaum Associates.; 1978. Accessed October 13, 2021. https://www.bristol.ac.uk/media-

    BACKGROUND
  • 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.

    PMID: 26043107BACKGROUND
  • 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.

    PMID: 11699809BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 28586790BACKGROUND
  • 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

    BACKGROUND
  • Beal SJ, Zion C, Mara CA, Patel MA, Bettencourt AF, Breitenstein SM, Vaughn LM, Greiner MV, Ammerman RT. Caregivers on point: a randomized treatment-control prevention trial for foster and kinship caregivers to reduce behavior challenges among children in foster care. Trials. 2024 Oct 10;25(1):670. doi: 10.1186/s13063-024-08524-9.

MeSH Terms

Conditions

Mental DisordersChild Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sarah Beal, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The Principal Investigator, Co-Investigators, Statistician, and the Clinical Research Coordinator conducting the caregiver-youth DPICS observation recording and coding will be blinded to study condition.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel, two-arm, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 14, 2023

Study Start

February 2, 2024

Primary Completion (Estimated)

September 7, 2026

Study Completion (Estimated)

August 30, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Consistent with the open science movement and with the directive of clinicaltrials.gov to include a data sharing plan in submissions, we will have the following data sharing policy: we will share with other investigators (1) all individual participant data after deidentification, and (2) study management documents (protocol, statistical analysis plan, consent form, analytic code, data dictionary).

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
These will be made available three months after publication of the primary article and ending five years after publication.
Access Criteria
Those requesting data will be required to submit a proposal to the PI. This will be reviewed by the investigative team for methodological soundness and scientific merit. Proposals approved by the PI will be shared with the legal department at Cincinnati Children's Hospital Medical Center and prosecuting attorneys and directors of children's services at Hamilton, Butler, and Montgomery counties for approval. Once approved by all parties, a data use agreement will be established with the outside investigator before data is shared. This plan is consistent with guidelines developed by the International Committee of Medical Journal Editors (Taichman,D S, et. al, 2017) and established memoranda of understanding between Cincinnati Children's and children's services agencies for research involving children in foster and kinship care.

Locations