|- candidate number||14510|
|- NTR Number||NTR3899|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-mrt-2013|
|- Secondary IDs||NL39376.101.13 VIPP-FC METC|
|- Public Title||Positive parenting in foster care.|
|- Scientific Title||Intervention for foster care: Effectivity of Video-feedback Intervention to Promote Positive Parenting in Foster Care (VIPP-FC).|
|- hypothesis||The goal of this study is to test the effects of the VIPP-FC within a Randomized Controlled Trial (RCT). The expectations of this study will be fourfold:|
1. Sensitivity of the parents and their sensitive disciplining towards the foster child will improve in the experimental condition;
2. The first expectation can be partly explained by improved stress regulation of the foster parent;
3. The quality of the attachment relationship between foster parent and child will improve and the child will be better able to regulate its behavior;
4. The preceding expectation could be explained by an improved stress regulation of the foster parent and child.
The primary goal of this study is to test the following hypotheses:
1. VIPP-FC has a stronger positive effect on sensitivity of the parents and their sensitive disciplining towards the child during interaction with the child than ‘care as usual’;
2. Oxytocin production in foster parents and their foster child will show stronger increase when interacting with one another in comparison to oxytocin production of foster parents in the ‘care as usual condition’;
3. A stronger decrease in cortisol production shall be observed Within foster parents and children in the experimental group compared to foster parents and children in the ‘care as usual condition’. The increase in sensitivity/sensitive disciplining will be mediated by an increase in oxytocin production and decrease in cortisol production;
4. The increase in oxytocin production mediates the effect of the VIPP-FC intervention on the increase in sensitivity/sensitive discipline;
5. VIPP-FC has a more pronounced effect on the reduction of behavioral problems in foster children when compared to the behavioral problems of children in the control condition;
6. VIPP-FC has a stronger effect on the decline of emotional and attachment problems in foster children compared with the emotional problems of children in the control condition.
|- Healt Condition(s) or Problem(s) studied||Externalizing behavior problems, internalizing problems, Attachment problems, Foster parents, Children|
|- Inclusion criteria||1. Children aged 1-6 placed in foster care and their foster families;|
2. Duration of the placement of the child in the foster family should be at least six months.
|- Exclusion criteria||1. There may not be a crisis placement that lasts less than six months;|
2. During the VIPP-FC intervention, the foster family will receive no other intervention (for instance, Video feedback Intervention).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2013|
|- planned closingdate||1-sep-2015|
|- Target number of participants||140|
|- Interventions||VIPP-FC is aimed at foster care and foster families. The intervention will be implemented by trained staff (foster employees, employees and students of Leiden University) of the participating institutions. The intervention will take place in the home of the foster family. Given the fact that mothers spend more time with their children, the intervention will be primarily be directed at foster mothers. The father of the family will be invited for the last part of the intervention. Daily routines and interactions of mother and child will be recorded by video. The recordings will last approximately between 10 and 30 minutes each. The trained staff member will give feedback on the interaction between mother and child, on the basis of the video footage. Feedback will concern positive interaction and sensitive disciplining primarily. During the intervention sessions, information will be given to the mother about the general development of young children and sensitive disciplining. Each family in the intervention will receive six house visits. The first four house visits will be two weeks apart from one another, between session four-five and five-six, a four week pause will be maintained. The overall duration of the intervention will be 3-4 months.
The VIPP-FC protocol states per session the construction, themes and assignments for the mother and child. In this manner all sessions are standardized, and equal for all families. Although the sessions are equal for all participants, feedback on the basis of the video recordings as well as the practical implementation of the intervention will be tailored on the specific mother-child pairs. Next to the general verbal information on the upbringing and development of children, each session will contain specific information on the themes sensitivity and disciplining. Tips are given each session to the mothers, these tips are expected to be executed and practiced with for the following session. In the last two sessions, all the themes will be repeated.
1. Exploration versus attachment behavior: showing the difference between a child’s play and a child looking for contact, including comments on the various reactions parents should be able to give, en knowing when to give a particular reaction;
2. Speaking for the child: improving accurate perception of (subtle-)signals of the child by verbalizing the facial expressions and non-verbal expressions of the child;
3. Sensitivity chain: explaining the importance of adequate responses on signals of the child (chain: signal from child – parent’s response – child’s reaction);
4. Sharing emotions: showing and encouraging the affective alignment from parents on positive and negative emotions of the child.
Boundaries and disciplining themes:
1. Inductive discipline and distraction. Induction (eg. indicating why something is forbidden or desired) and distraction are recommended tools as reaction on provoking situations or difficult behavior. Using induction will promote empathy in the child;
2. Positive reinforcement by praising the child for desirable behavior, and ignoring negative attention seeking;
3. Using a sensitive time-out to avoid escalation of tantrums and keeping the situation under control in a sensitive way;
4. Empathy towards the child, combined with consistent discipline and clear cut boundaries.
Foster care themes:
1. Responding to missing or minimum signals from foster children in a sensitive way;
2. The importance of physical contact on stress regulation.
The control group will receive care as usual.
|- Primary outcome||Primary study parameters in this study regard the quality of the attachment relationship between foster parent and their foster child, the sensitivity of the parents and their sensitive disciplining towards the child, the attitude of foster parents towards parenting, behavioral- and emotional problems of the foster child, neurobiological parameters of stress regulation (cortisol (saliva and hair), oxytocin measures and alpha amylase measures), growth parameters (length, weight and head circumference) and ear temperature measurements.|
|- Secondary outcome||Possible confounders such as sex, age, social economic status (SES), history of the foster child and cultural background of foster parents and child will be measured with a questionnaire (Vragenlijst Gezinssituatie).|
|- Timepoints||1. Baseline measure;|
2. Effect measure;
3. Follow-up measurement.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. L.R.A. Alink|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. L.R.A. Alink|
|- Sponsor/Initiator ||Universiteit Leiden, Centrum voor Gezinstudies, Yulius Academie|
(Source(s) of Monetary or Material Support)
|NWO Meerwaarde subsidie, Kinderpostzegels|
|- Brief summary||Children placed in foster homes have often had a rough start of their lives while being taken care of by their biological parents. Foster children are significantly more insecure- or disorganized attached than children raised by their biological parents. The insecure- and especially disorganized attachment forms a risk for the later development of psychopathology within these foster children.
Scientific research shows that insecure and disorganized attached children can still form a secure attachment relation with their foster parents if they have positive attachment experiences in new nurture situations. Foster parent are, more than often, confronted with foster child behaviors that denote an insecure and disorganized attachment past of that child. It is thus most important that the foster parents develop skills that give way to cope and deal with the individual problems of their foster child(-ren).
The intervention VIPP-SD (Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline; Juffer, Bakermans-Kranenburg, & van IJzendoorn, 2008) is an intervention designed to support parents in coping with disrupted and troublesome behavior of their children. This method enhances the sensitivity of the parents and their sensitive disciplining towards the child. VIPP-SD is approved and proven to be effective by the ‘Nederlands Jeugdinstituut’.
VIPP-SD has been extended with two components in order to be applied within the foster care. The following components are added:
1. Foster parents will be trained in recognizing and adequately responding to the signals that are distinctive for foster children with attachment difficulties.
2. Activities will be implemented that are explicitly designed to promote physical contact between the parents and their foster child.
The extended version of the VIPP-SD, designed to address foster care, will be named VIPP-FC (Video-feedback Intervention to promote Positive Parenting – Foster Care).
The aim of the present study is to test the effects of VIPP-FC. If this intervention will be effective in enhancing the sensitivity of the parents and their sensitive disciplining towards the child, it should be implemented widely in foster care. The VIPP-FC intervention could thereby improve the mental wellbeing of the parents and their foster child.
The study design will be a RCT with an experimental- and a control condition. Families with a new foster child ( from age 1 to 6 years) will be recruited within one to two months after placement of the child within the foster family. Only after receiving fully signed informed consent from the parents and/or legal guardian will the families be included into the study. No later than one month after inclusion, an baseline assessment will be conducted in which the quality of the foster parent – child interaction will be measured, a mapping of the characteristics of child and parent and physiologic measurements in the form of saliva swabs and the collection of lock of hair. After the baseline measure, families will be randomly assigned to either the control or intervention condition. In the control condition, families will receive care as usual. The VIPP-FC condition will receive the intervention that will last for approximately 3-4 months. After the intervention, or after 3-5 months ‘care as usual’, a effect measure will take place. Two months after the post-study assessment there will be a follow-up measurement.
|- Main changes (audit trail)|
|- RECORD||13-mrt-2013 - 31-mrt-2014|