|- candidate number||3429|
|- NTR Number||NTR1338|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jun-2008|
|- Secondary IDs||MEC 2007/202 |
|- Public Title||The effectiveness of the Triple P programme to support parenting in Dutch preventive child healthcare: a randomised controlled study|
|- Scientific Title||The effectiveness of the Triple P programme to support parenting in Dutch preventive child healthcare: a randomised controlled study|
|- Healt Condition(s) or Problem(s) studied||Psychosocial, Behavioural disorders, Parenting problems|
|- Inclusion criteria||1. Children aged 9-11 years. |
2. Total SDQ-score in the sub-clinical range (11-13).
3. Parents recognize / acknowledge detected behavioural or psychosocial problems and are receptive to treatment.
|- Exclusion criteria||1. A diagnosis of developmental delay, developmental disorder (e.g. autism), conduct
disorder or ADHD. |
2. Currently receiving treatment for behavioural problems.
3. A chronic disease for which 3 or more medical consultations in the past 6 months.
4. Parental divorce, death or severe disease of someone to whom the child feels attached (parent, sib, grandparent, friend, nanny) in the past 6 months.
5. Parents in therapy for psychological or relationship problems.
6. Parents unable to read or speak Dutch.
7. Severe and/of general behavioural or emotional problems beyond the scope of the Triple P level 3 intervention.
8. Suspected parental dysfunction as child maltreatment, psychiatric disease, alcohol or drug abuse.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2008|
|- planned closingdate||30-mrt-2012|
|- Target number of participants||162|
|- Interventions||The intervention concerns a maximum of four short (20-30 minutes) contacts with a PCH nurse, based on level 3 of Triple P. It consists of practical advice and coaching on managing a specific behavioural problem during 4 individual consultations with parents and their child by a trained nurse.
The effects of the intervention will be studied in a randomised controlled trial. Parents are randomised to the intervention or a control group. The control group receives usual care provided by the Dutch Preventive Child Healthcare (PCH, ‘jeugdgezondheidszorg’) in case of mild psychosocial problems.|
|- Primary outcome||The primary outcome of the study is the change in problem behaviour after intervention.|
|- Secondary outcome||Since the intervention aims at parenting as mediator, the secondary outcome of the study is parenting
|- Timepoints||Timepoints: outcome measures will be assessed (by means of questionnairs) at inclusion, and immediately after the intervention. For the evaluation of long-term effects, the study protocol provides an additional follow-up 6 and 12 months after the intervention. |
The following instruments will be applied:
- Family Background Questionnaire (FBQ)
- Strengths and Difficulties questionnair (SDQ)
- Eyberg Child Behaviour Inventory (ECBI)
- Parenting scale
- Problem setting and behaviour checklist
- Nijmegian Parental Stress Index (Nijmeegse Ouderlijke Stress Index - NOSIK)
- Depression Anxiety Stress Scale (DASS)
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. W. Spijkers|
|- 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, such as fear, anxiety and depression, occur frequently in children and may lead to serious restrictions in daily functioning. Dutch Preventive Child Healthcare (PCH, ‘jeugdgezondheidszorg’) can play an important role in their prevention including early treatment, since it reaches more than 90% of all children. The Triple P program is likely to fit the needs of PCH regarding parenting support, but its effectiveness in Dutch PCH has to be shown as yet. |
Triple P-Positive Parenting Programme is a prevention programme which aims at prevention and decreasing psychosocial problems in children by providing parenting support. Triple P is a multi-level system of family intervention, which provides five levels of intervention of increasing strength. Level 3 consists of practical advice and coaching on managing a specific behavioural problem during 4 short, individual consultations (20-30 minutes) with parents and their child by a trained PCH nurse.
This study aims to determine the effectiveness of Triple P, level 3, in Dutch PCH. Parents of children with increased but still subclinical levels of psychosocial problems are assigned at random to the experimental group (Triple P, level 3) or to a control group (care as usual). The study will include 81 children in each treatment arm (total: 162). Outcome measures as problem behaviour and parenting behaviour will be assessed before and after the intervention in both groups.
|- Main changes (audit trail)|
|- RECORD||11-jun-2008 - 17-sep-2008|