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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: Netherlands Trial Register
Last refreshed on: 28 April 2013
Main ID:  NTR2179
Date of registration: 26/01/2010
Primary sponsor: University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ)
Public title: Triple P for NICU graduates (NL: Triple P na de couveuse).
Scientific title: Effectiveness of the Triple P program for parents of NICU graduates with emotional and/or behavioral problems. (NL: Triple P na de couveuse: effectiviteit van opvoedingsondersteuning bij gezinnen waarin een peuter of kleuter opgroeit met emotionele en/of gedragsproblemen). -
Date of first enrolment: 18/5/2009
Target sample size: 86
Recruitment status: recruiting
URL:  http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2179
Study type:  intervention
Study design:  Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: Single arm  
Countries of recruitment
The Netherlands
Contacts
Name: R.  Schappin
Address:  P.O. Box 85090 3508 AB Utrecht The Netherlands
Telephone: +31 (0)88 75 541 11
Email: r.schappin@umcutrecht.nl
Affiliation: 
Name: R.  Schappin
Address:  P.O. Box 85090 3508 AB Utrecht The Netherlands
Telephone: +31 (0)88 75 541 11
Email: r.schappin@umcutrecht.nl
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Parents of four cohorts (2004-2007) of NICU-graduates, now aged 2;6-5 years, will be addressed. Inclusion criteria for these children are that they have a gestational age < 32 weeks and/or a births weight of < 1500 grams, or a gestational age between 37 and 42 weeks with perinatal asfyxia.
Exclusion criteria: Excluded are parents of children with motor- and/or intellectual disabilities (GMFCS class 4/5; IQ score < 70), parents who do not sufficiently speak the Dutch language, and parents of children who fit the inclusion criteria but already receive professional support for the emotional and/or behavioral problems of their child.

Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Premature infants, Perinatal asphyxia, Emotional problems, Parenting, Low birth weight, Behavioral problems

Intervention(s)
The intervention is an evidence-based parenting program, Triple P (level 3).
It aims at improving the competences and the self-reliance of parents regarding their parenting behaviour. Triple P tries to establish a more competent parenting style in dealing with the child's emotional and/or
behavioral problems, less use of cohersion and negative discipline, better communication about parenting
between parents and between parent and child, and less parenting stress for the parents. The duration of the intervention is four times 30 minutes.
Within one year time intervention group will fill out questionnaires four times, they will visit the childrens hospital six times to recieve Triple P and for observations of mother-child interaction. At the same timepoints, the waitlist-control group will fill out questionnaires at four times, and visit the hospital four times for observations of mother-child interaction. After six months, Triple P is optional for the waitlist-control group.
Primary Outcome(s)
Emotional and behavioral problems as indicated by the parents, measured with the Total Problems scale of the Child Behavior Checklist (CBCL).
Secondary Outcome(s)
Internalising and externalising problems as indicated by the parents (CBCL), disruptive behavior (Eyberg Child Behavior Inventory), parents' parenting experiences (Nijmeegse Ouderlijke Stress Index; Dutch Parenting Stress Index), attitude of parents towards parenting (Child Rearing Practices Report), vulnerability of the child as perceived by the parents (Vulnerable Child Scale), internalising and externalising problems as indicated by the teacher (Teacher Report Form), observed parent-child interaction (Three Boxes Task) and number of families that need more (intensive) counselling after the intervention.
Secondary ID(s)
NL24922.041.08
Source(s) of Monetary Support
ZON-MW, The Netherlands Organization for Health Research and Development
Secondary Sponsor(s)
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