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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01821755
Other study ID # ID0032
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 19, 2013
Last updated April 4, 2013
Start date January 2011
Est. completion date May 2013

Study information

Verified date April 2013
Source Vrije Universiteit Brussel
Contact n/a
Is FDA regulated No
Health authority Belgium: Youth Welfare Agency
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 63
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 12 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Foster parent intervention
parent management training for foster parents, consisting of 10 individual home visits and 3 group sessions. Duration is four months

Locations

Country Name City State
Belgium Vrije Universiteit Brussel Brussel Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in foster child's externalizing problems from baseline to post-intervention (3.5 months later) 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) No
Primary Change in foster child's externalizing problems from post-intervention to follow-up (3 months later) 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). No
Secondary Change in foster parent's parenting stress from baseline to post-intervention (3.5 months later) 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) No
Secondary Change in foster mother's parenting stress from post-intervention to follow-up (3 months later) 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). No
Secondary Client satisfaction Dutch Questionaire for client satisfaction and effect At post-intervention (immediately after the intervention has ended, which is on average 3.5 months later than the baseline measurment No
Secondary Change in foster mother's parenting behavior from baseline to post-intervention (3.5 months later) 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) No
See also
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Completed NCT02203708 - Supportive Program for Mother With BPD N/A
Completed NCT03539341 - Parenting for Lifelong Health - Thailand N/A
Active, not recruiting NCT03880383 - BRIGHT Coaching Program for Families N/A
Completed NCT02955199 - Stage III Community-based Efficacy Trial for Mothering From the Inside Out N/A

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