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Triple P for NICU graduates (NL: Triple P na de couveuse).


- candidate number7682
- NTR NumberNTR2179
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jan-2010
- Secondary IDsNL24922.041.08 CCMO
- Public TitleTriple P for NICU graduates (NL: Triple P na de couveuse).
- Scientific TitleEffectiveness 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).
- ACRONYM
- hypothesisAt toddler age, NICU graduates show more emotional and behavioral problems than term born children without a medical ondition. Having a child in neonatal intensive care burdens parenting, not only during the acute phase of illness but also in the years thereafter. Most interventions up till now take place during the NICU period or in the first year of life. These interventions usually aim at directly stimulating the motor and cognitive development of the child. The effects of early interventions are positive, but at school age the positive effects have usually disappeared. As of yet, there are no studies of interventions aimed at parenting support of parents of NICU graduates at toddler age, while emotional and/or behavioral problems surface specifically at this age. The objective is to study the effectiveness of the Triple P program compared to a control group, for parents and their NICU-graduates with emotional and/or behavioral problems. Effectivenes concerns children's problems, parents' parenting experiences, and the interaction between parents and child.
- Healt Condition(s) or Problem(s) studiedPremature infants, Perinatal asphyxia, Emotional problems, Parenting, Low birth weight, Behavioral problems
- Inclusion criteriaParents 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 criteriaExcluded 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 18-mei-2009
- planned closingdate1-sep-2012
- Target number of participants86
- InterventionsThe 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 outcomeEmotional and behavioral problems as indicated by the parents, measured with the Total Problems scale of the Child Behavior Checklist (CBCL).
- Secondary outcomeInternalising 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.
- TimepointsThe primary outcome will be at 6 months after inclusion. All secondary outcomes will be at 12 months after inclusion.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. R. Schappin
- CONTACT for SCIENTIFIC QUERIESDrs. R. Schappin
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryAt toddler age, NICU graduates show more emotional and behavioral problems than term born children without a medical condition. Having a child in neonatal intensive care burdens parenting, not only during the acute phase of illness but also in the years thereafter. Most interventions up till now take place during the NICU period or in the first year of life. These interventions usually aim at directly stimulating the motor and cognitive development of the child. The effects of early interventions are positive, but at school age the positive effects have usually disappeared. As of yet, there are no studies of interventions aimed at parenting support of parents of NICU graduates at toddler age, while emotional and/or behavioral problems surface specifically at this age. The objective of this study is to investigate the effectiveness of the Triple P program compared to a control group, for parents and their toddler-aged NICU-graduates with emotional and/or behavioral problems. The intervention is an evidence-based parenting program, Triple P (level 3), which aimes at improving the competences and the self-reliance of parents regarding their parenting behaviour. The duration of the intervention is four times 30 minutes. Effectivenes of Triple P concerns children's problems, parents' parenting experiences, and the interaction between parents and child.
- Main changes (audit trail)
- RECORD26-jan-2010 - 7-feb-2010


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