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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04519229
Other study ID # RK/30062020
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 30, 2019
Est. completion date December 30, 2024

Study information

Verified date March 2023
Source Kronoberg County Council
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Child-Parent Psychotherapy
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.

Locations

Country Name City State
Sweden Department of Research and Development, Region Kronoberg Växjö

Sponsors (2)

Lead Sponsor Collaborator
Kronoberg County Council Stiftelsen Allmänna Barnhuset

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Adherence Log of clinicians' ratings of fidelity to the method of Child-Parent Psychotherapy and adaptions immediately after each session, up to 20 times After 20 completed sessions or immediately after termination of the intervention if terminated earlier than 20 sessions
Other Childrens' experiences of participating in Child-Parent Psychotherapy Qualitative data from interviews with children 3-6 years old After 20 completed sessions or immediately after termination of the intervention if terminated earlier than 20 sessions
Other Foster parents' experiences of participating in Child-Parent Psychotherapy Qualitative data from interviews with foster parents After 20 completed sessions or immediately after termination of the intervention if terminated earlier than 20 sessions
Other Clinicians' experiences of working with Child-Parent Psychotherapy with Children in foster care Qualitative data from interviews with clinicians After 20 completed sessions or immediately after termination of the intervention if terminated earlier than 20 sessions
Primary 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
Primary 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
Primary 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
Primary 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 Change from baseline score on the Hopkins Symptom Check List-25 at 20 completed sessions or at termination of intervention if terminated earlier. Caregiver report of psychological distress and symptoms. Minimum score 0, maximum score 100, higher score indicating worse outcome. After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Secondary Change from baseline score on the Impact of Event Scale-Revised at 20 completed sessions or at termination of intervention if terminated earlier. Caregiver report of symptoms of post-traumatic stress. Minimum score 0, maximum score 80, higher score indicating worse outcome. After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Secondary Change from baseline score on the Life Incidence of Traumatic Events Questionnaire at 20 completed sessions or at termination of intervention if terminated earlier. Caregiver report of 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
Secondary Change from baseline score on the Caregiving Helplessness Questionnaire at 20 completed sessions or at termination of intervention if terminated earlier. Caregiver report on caregiving experiences. Minimum score 18, maximum score 90, higher score indicating worse outcome. After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
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