- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01821755
Effectiveness of a Foster Parent Intervention: Results of a Trial (PVO)
April 4, 2013 updated by: Femke vanschoonlandt, Vrije Universiteit Brussel
Development, Implementation and Evaluation of a Foster Parent Intervention
The hypothesis of the study is that the intervention leads to a reduction in foster children's externalizing problems and foster parents' parenting stress and that this in turn leads to a reduction in the number of breakdowns of foster placements.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vlaams-Brabant
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Brussel, Vlaams-Brabant, Belgium, 1050
- Vrije Universiteit Brussel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 12 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- foster child has a borderline or clinical score on one of the small-band externalizing scales or the broad-band externalizing scale of the Child Behavior Checklist (CBCL)
Exclusion Criteria:
foster child:
- has a mental retardation,
- autism,
- uses psychotropic medication in an inconsistent way,
- behavioral problems are the result of medical problems or medication, foster parents:
- have insufficient knowledge of Dutch,
- have low cognitive abilities,
- are already receiving professional support for the foster child's externalizing problems,
- are divorcing.
Moreover, foster placements were excluded if at least two of the following criteria were present:
- foster parents considered terminating the foster placement during the past two months
- were experiencing psychological distress (measured with the General Health Questionnaire (GHQ; Koeter & Ormel, 1991) and defined as a score ≥ 2),
- their foster child had a sum score above 3 (for children < 6 years) or 5 (for children ≥ 6 years) on the critical CBCL-items.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Behavioral: Foster parent intervention
Foster parents receive a foster parent intervention consisting of 10 individual home visits and three group sessions.
Duration of the intervention is four months
|
parent management training for foster parents, consisting of 10 individual home visits and 3 group sessions.
Duration is four months
|
|
NO_INTERVENTION: Control
waiting-list control group who receive care-as-usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in foster child's externalizing problems from baseline to post-intervention (3.5 months later)
Time Frame: Assessed at two time points: at baseline (before the start of the intervention) en post-intervention (immediately after the intervention has ended, which is on average 3.5 months after the baseline measurement)
|
T-score for the externalizing subscale of the Child Behavior Checklist (CBCL)
|
Assessed at two time points: at baseline (before the start of the intervention) en post-intervention (immediately after the intervention has ended, which is on average 3.5 months after the baseline measurement)
|
|
Change in foster child's externalizing problems from post-intervention to follow-up (3 months later)
Time Frame: Assessed at post-interventio (immediately after the intervention has ended, which is about 3.5 months after the baseline measurement) and at follow-up (which is thee months later than the post-intervention measurement).
|
The T-score of the Externalizing scale of the Child Behavior Checklist (CBCL)
|
Assessed at post-interventio (immediately after the intervention has ended, which is about 3.5 months after the baseline measurement) and at follow-up (which is thee months later than the post-intervention measurement).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in foster parent's parenting stress from baseline to post-intervention (3.5 months later)
Time Frame: Assessed at two time points: at baseline (before the start of the intervention) en post-intervention (immediately after the intervention has ended, which is on average 3.5 months after the baseline measurement)
|
Nijmegen Questionnaire for the Parenting Situation
|
Assessed at two time points: at baseline (before the start of the intervention) en post-intervention (immediately after the intervention has ended, which is on average 3.5 months after the baseline measurement)
|
|
Change in foster mother's parenting stress from post-intervention to follow-up (3 months later)
Time Frame: Assessed at post-interventio (immediately after the intervention has ended, which is about 3.5 months after the baseline measurement) and at follow-up (which is thee months later than the post-intervention measurement).
|
The Nijmegen Questionnaire for the parenting situation
|
Assessed at post-interventio (immediately after the intervention has ended, which is about 3.5 months after the baseline measurement) and at follow-up (which is thee months later than the post-intervention measurement).
|
|
Client satisfaction
Time Frame: At post-intervention (immediately after the intervention has ended, which is on average 3.5 months later than the baseline measurment
|
Dutch Questionaire for client satisfaction and effect
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At post-intervention (immediately after the intervention has ended, which is on average 3.5 months later than the baseline measurment
|
|
Change in foster mother's parenting behavior from baseline to post-intervention (3.5 months later)
Time Frame: Assessed at two time points: at baseline (before the start of the intervention) en post-intervention (immediately after the intervention has ended, which is on average 3.5 months after the baseline measurement)
|
The Ghent Parenting Behavior Scale
|
Assessed at two time points: at baseline (before the start of the intervention) en post-intervention (immediately after the intervention has ended, which is on average 3.5 months after the baseline measurement)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ANTICIPATED)
May 1, 2013
Study Completion (ANTICIPATED)
May 1, 2013
Study Registration Dates
First Submitted
February 19, 2013
First Submitted That Met QC Criteria
March 29, 2013
First Posted (ESTIMATE)
April 1, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
April 5, 2013
Last Update Submitted That Met QC Criteria
April 4, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- ID0032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.