Problematic Behavior in ChildrenPVONCT01821755
Effectiveness of a Foster Parent Intervention: Results of a Trial
A study testing Foster parent intervention in people with Problematic Behavior in Children and Parent-child Problem, run by Vrije Universiteit Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Problematic Behavior in Children, Parent-child Problem
- What is being tested?
- Foster parent intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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,
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Foster parent intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foster parent interventionBehavioural
parent management training for foster parents, consisting of 10 individual home visits and 3 group sessions. Duration is four months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Foster parent intervention |
| Control | No intervention | waiting-list control group who receive care-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Nijmegen Questionnaire for the Parenting Situation
Measured: 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)
The Nijmegen Questionnaire for the parenting situation
Measured: 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
Dutch Questionaire for client satisfaction and effect
Measured: 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)
The Ghent Parenting Behavior Scale
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startJan 2011
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problematic Behavior in ChildrenStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Femke vanschoonlandt, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821755
- Sponsor's protocol ID
- ID0032
- Acronym
- PVO
- Status last verified
- Apr 2013
- First submitted
- 19 Feb 2013
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Implementation and Evaluation of a Foster Parent Intervention
- ClinicalTrials.gov ID
- NCT01821755
- Acronym / sponsor ID
- PVO / ID0032
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Foster parent intervention | Experimental | Behavioral: Foster parent interventionFoster parents receive a foster parent intervention consisting of 10 individual home visits and three group sessions. Duration of the intervention is four months |
| Control | No intervention | –waiting-list control group who receive care-as-usual |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foster parent interventionparent management training for foster parents, consisting of 10 individual home visits and 3 group sessions. Duration is four months | Behavioural | Behavioral: Foster parent intervention |
Primary outcome
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)
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)
4 secondary outcomes
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)
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).
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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foster parent intervention in people with Problematic Behavior in Children and Parent-child Problem, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2013.