NCT04519229

Brief Summary

Children in foster care have an increased risk of exposure to adverse experiences during childhood and across the lifespan. In current studies of interventions children in foster care are often excluded, or they are too few to be included in statistical analyses of outcomes. As a consequence, knowledge on feasibility of treatment methods for some of the most exposed and maltreated children in society is sparse. Child-Parent Psychotherapy (CPP) is an intervention for children 0-6 years who have been exposed to adverse and traumatic events. CPP is currently being implemented in Sweden. The aim of this study is to investigate the feasibility of CPP for children in foster care.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

June 30, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

6 years

First QC Date

July 9, 2020

Last Update Submit

October 8, 2024

Conditions

Keywords

ChildrenAdverse childhood eventsPost traumatic stressChildren in foster carePsychotherapy

Outcome Measures

Primary Outcomes (4)

  • Change from baseline score on the Strengths and Difficulties Questionnaire - Parent version at 20 completed sessions or at termination of intervention if terminated earlier.

    Caregiver report of child psychopathology. Minimum score 0, maximum score 40, higher score indicating worse outcome.

    After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions

  • Change from baseline score on the Trauma Symptom Checklist for Young Children at 20 completed sessions or at termination of intervention if terminated earlier.

    Caregiver report of child symptoms of post-traumatic stress. Minimum score 90, maximum score 360, higher score indicating worse outcome.

    After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions

  • Change from baseline score on the Linköping Youth Life Experiences Scale at 20 completed sessions or at termination of intervention if terminated earlier.

    Caregiver report of child exposure to traumatic and adverse life events. Minimum score 0, maximum score 41, higher score indicating worse outcome.

    After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions

  • Change from baseline score on the Child-Parent Psychotherapy Symptom Screener at 20 completed sessions or at termination of intervention if terminated earlier.

    Caregiver report of child symptoms of post-traumatic reactions. Minimum score 0, maximum score 93, higher score indicating worse outcome.

    After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions

Secondary Outcomes (4)

  • Change from baseline score on the Hopkins Symptom Check List-25 at 20 completed sessions or at termination of intervention if terminated earlier.

    After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions

  • Change from baseline score on the Impact of Event Scale-Revised at 20 completed sessions or at termination of intervention if terminated earlier.

    After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions

  • Change from baseline score on the Life Incidence of Traumatic Events Questionnaire at 20 completed sessions or at termination of intervention if terminated earlier.

    After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions

  • Change from baseline score on the Caregiving Helplessness Questionnaire at 20 completed sessions or at termination of intervention if terminated earlier.

    After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions

Other Outcomes (4)

  • Adherence

    After 20 completed sessions or immediately after termination of the intervention if terminated earlier than 20 sessions

  • Childrens' experiences of participating in Child-Parent Psychotherapy

    After 20 completed sessions or immediately after termination of the intervention if terminated earlier than 20 sessions

  • Foster parents' experiences of participating in Child-Parent Psychotherapy

    After 20 completed sessions or immediately after termination of the intervention if terminated earlier than 20 sessions

  • +1 more other outcomes

Study Arms (1)

Children in fostercare in CPP-treatment

Children in foster care taking part in Child-Parent Psychotherapy

Behavioral: Child-Parent Psychotherapy

Interventions

Relationship-based trauma focused psychotherapy for Children 0-6 years old and their caregivers. The objective is to decrease symptoms of post-traumatic tress and re-establish a secure attachment for the child and good caregiving from the caregiver/s.

Children in fostercare in CPP-treatment

Eligibility Criteria

Age0 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children in foster care offered Child-Parent Psychotherapy at any of the nine participating agencies.

You may qualify if:

  • Age 0-6 years
  • being offered Child-Parent Psychotherapy as part of their regular treatment

You may not qualify if:

  • Families in need of translator for interviews.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Research and Development, Region Kronoberg

Vaxjo, 35112, Sweden

Location

Study Officials

  • Karin Pernebo, PhD

    Department of Psychology, Linnaeus University, Sweden and Department of Research and Development, Region Kronoberg, Sweden

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2020

First Posted

August 19, 2020

Study Start

June 30, 2019

Primary Completion

June 30, 2025

Study Completion

December 30, 2025

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations