NCT01821755

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

2.3 years

First QC Date

February 19, 2013

Last Update Submit

April 4, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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).

Secondary Outcomes (4)

  • Change in foster parent's parenting stress from baseline to post-intervention (3.5 months later)

    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)

    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

    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)

    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)

Study Arms (2)

Behavioral: Foster parent intervention

EXPERIMENTAL

Foster parents receive a foster parent intervention consisting of 10 individual home visits and three group sessions. Duration of the intervention is four months

Behavioral: Foster parent intervention

Control

NO INTERVENTION

waiting-list control group who receive care-as-usual

Interventions

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

Behavioral: Foster parent intervention

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Brussels, Vlaams-Brabant, 1050, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

February 19, 2013

First Posted

April 1, 2013

Study Start

January 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations