|- candidate number||8876|
|- NTR Number||NTR2681|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jan-2011|
|- Secondary IDs||2008-272 METC UMCG|
|- Public Title||Early identification of (risks for) social-emotional problems in Preventive Child Healthcare: The effectiveness of a Family Centered approach.|
|- Scientific Title||Early identification of (risks for) social-emotional problems in Preventive Child Healthcare: The effectiveness of a Family Centered approach.|
|- Healt Condition(s) or Problem(s) studied||Psychosiocial problems|
|- Inclusion criteria||Newborn infants (age at inclusion < 3 months) with parents visiting Preventive Child Healthcare (PCH).|
|- Exclusion criteria||1. Parents do not have enough mastery of the Dutch language to fill out the questionnaires;|
2. Parents receive healthcare for their newborn from another institute than PCH (f.e. from hospital).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-okt-2009|
|- planned closingdate||1-jun-2011|
|- Target number of participants||3600|
|- Interventions||The FC-approach is a Family Centered method aimed to identify (risks for) social-emotional problems in infants (0-18 months). With the FC-approach, the broad developmental context is discussed with parents regarding five domains: Competence of the parent, role of the partner, social support, perceived barriers and the social-emotional well-being of the child. For each domain, several questions regarding that specific domain are asked by the Child Health professional (CHP) during each routine PCH-visit. First possible parental concerns are elicited, providing a starting point for further communication. In communication with parents, collaboration with and empowerment of parents are central features. During the second PCH-visit at child age of 8 weeks, the CHP gets 15 minutes extra (30 minutes in total) to treat the 5 domains exhaustively.
Care as usual consists of examining and monitoring the general health and (social-emotional) development of children during routine PCH-visits of 15 minutes. The national guidelines for PCH, described in the Guidelines of the Dutch National Institute for Public Health and the Environment (RIVM 2003) are followed.
|- Primary outcome||Primary outcome in the study is the proportion of social-emotional problems identified at child age between 2-18 months in both the intervention- and control group and the reliability of identification by CHP’s compared to internationally validated questionnaires concerning social-emotional development. |
Furthermore the concordance between the information of the FC-approach domains collected by CHP’s and parent-reported outcomes on these domains, measured by different questionnaires will be analyzed.
|- Secondary outcome||Secondary outcomes are the degree to which needs of parents are met and their willingness to disclose concerns is enhanced. |
|- Timepoints||1. 0-18 months: Information from medical records of participating children;|
2. < 3 months: All parents receive the FC-questionnaire, assessing met and unmet needs of parents and their willingness to disclose concerns;
3. 18 months: All parents receive the FC-questionnaire and the Child Behavior Checklist (CBCL).
When a CHP accomplishes a non-routine activity regarding the social-emotional development of a child at age of 2, 3, 4, 6, 9, 11 or 14 months, parents will be invited for additional questionnaires, used for validation of the FC-approach. For each of these families, two control-families will be asked to complete the same questionnaires. The following questionnaires will be used:
1. Ages and Stages Questionnaire (ASQ-SE);
2. Nijmegian Parental Stress Index, short version (Nijmeegse Ouderlijke Stress Index - NOSIK);
3. Problem setting and Behaviour Checklist (PSCB);
4. SF-12 (abbreviated version of the 36-Item Short Form Health Survey);
5. Family Assessment Device (FAD);
6. Social Support List (SSL);
7. Loneliness-score (Eenzaamheidsscore);
8. Questionnaire Rots-de Vries (Rots –de Vries 2002).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Margriet Hielkema|
|- CONTACT for SCIENTIFIC QUERIES||Prof. MD, PhD, S.A. Reijneveld|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Department of Health Sciences|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Psychosocial problems have been described as relatively common in childhood. Early identification of worries, risk factors or problems concerning psychosocial development is important because it may lead to early intervention which in turn may lead to a better prognosis for the child and its environment. |
Dutch Preventive Child Healthcare (PCH) plays an important role in this early identification process, as more than 90% of children are seen in PCH on a regular basis. The FC-approach seems a promising method for early identification and can be integrated in routine PCH. With the FC-approach, during each routine PCH-visit 5 domains will be discussed with parents regarding the broad developmental context from the parents’ point of view. In communication with parents, attunement to their needs and wishes and empowerment of parents are central features.
Evidence of the effectiveness of the FC-approach is lacking. In this study two regions (intervention and care as usual) will be compared for identified social-emotional problems based on data of 1800 children (0-18 months) in each region. Also met and unmet needs of parents and their willingness to disclose concerns will be compared between the regions. Within the study the FC-approach will be validated. For validation, data from questionnaires, regarding the FC-approach domains, are used from 242 parents where PCH has accomplished a non-regular activity regarding the social-emotional development of the child. For each of these families, two control-families, where PCH did not have to undertake non-regular activities, will be invited for the complementary questionnaires.
|- Main changes (audit trail)|
|- RECORD||5-jan-2011 - 16-jan-2011|