|- candidate number||5656|
|- NTR Number||NTR1778|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-apr-2009|
|- Secondary IDs||80-82430-98-8044 ZonMW|
|- Public Title||Sleepingproblems in young children; prevention and intervention in Youth Healthcare.|
|- Scientific Title||Sleepingproblems in young children; prevention and intervention in Youth Healthcare.|
|- ACRONYM||"Lekker slapen en morgen gezond weer op"|
|- hypothesis||1. Giving specific information about sleep to parents with children younger than 2 months old will reduce the prevalence of sleepingproblems in children in the age of 2 months to 4 years; |
2. The modified behavioural intervention of Schregardus is more effective in reducing the degree and intensity of sleepingproblems in children in the age of 6 months to 4 years old than to care-as-usual, and is expected to improve parenting competence.
|- Healt Condition(s) or Problem(s) studied||Sleep disorders|
|- Inclusion criteria||Children aged 6 months to 4 years with sleeping problems:|
1. Mild to severe bedtime problems;
2. Mild to severe night wakings;
3. Mild to severe sleep shortage.
|- Exclusion criteria||1. Infants with a somatic cause for their sleeping problems;|
2. Infants with severe family problems (abuse, neglect) as a cause for their sleeping problems;
3. Infants who are ill of who have a form of mental retardation;
4. Infants whose parents have psychopathological problems (f.e. a psychosis);
5. Multiproblem families can be excluded when the healthcare worker feels the need to refer to more intensive care.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2009|
|- planned closingdate||31-dec-2011|
|- Target number of participants||350|
|- Interventions||Behavioural therapeutical intervention: Modified intervention of schregardus with patient-preference (parents can choose between direct extinctin and gradual extinction). |
Control group receives care-as-usual as offered in Youthhealthcare.
|- Primary outcome||1. Sleeping problems:|
A. Bedtime problems;
B. Night wakings;
C. Sleep shortage.
2. Behavioural problems of the child.
|- Secondary outcome||1. Parenting;|
A. Parenting style of parents;
B. Parenting problems of parents;
C. Parental efficacy.
2. Psychosocial problems of parents.
|- Timepoints||1. T0: at inclusion (sleeping problems, behavioural problems of the child, parenting, psychosocial problems of parents);|
2. T1: 1 week after intervention (sleeping problems, behavioural problems of the child);
3. T2: 3 weeks after intervention (sleeping problems, behavioural problems of the child);
4. T3: 6 weeks after intervention (sleeping problems, behavioural problems of the child);
5. T4: 6 months after intervention (sleeping problems, behavioural problems of the child, parenting, psychosocial problems of parents).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| L. Nawijn|
|- CONTACT for SCIENTIFIC QUERIES|| L. Nawijn|
|- Sponsor/Initiator ||TNO Quality of Life, Division of Child Health, Prevention and Physical Activity|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Sleepingproblems are common in young children; international studies have shown a prevalence of 20-30% in infants, toddlers and pre-schoolchildren. Correlations have been shown between sleepshortage in children and behavioural, cognitive and social problems, parental stress, family problems and childabuse. Furthermore, in children of all ages, a consistent relationship has been found between sleepshortage and overweight and obesity. It can be expected that when sleep improves in children, these problems can be reduced, and health and well-being of both child and parent can be improved. A recent meta-analysis study showed that giving parents information about sleep prior to the existence of sleepingproblems can have a preventive effect on the development of sleepingproblems in children. When sleepingproblems are already present, behavioural therapy based on extintion and stimuluscontrol is most effective.
This study will examine the effectiveness of two interventions: A preventive and a therapeutical intervention, both carried out by Youth Healthcare nurses. The preventive intervention consists of giving information about sleep to parents of children younger than 2 months old. We expect that this will reduce the prevalence of sleepingproblems in these children between the age of 2 to 18 months old, as compared to care-as-usual. 2400 children will be included in this study. The therapeutical intervention consists of a modified behavioural intervention based on extinction ('sleeping problems in children' by Schregardus, 2001) given to children aged 6 months to 4 years old with moderate to severe sleepingproblems. 350 children will be included in this study. We expect to see a reduction of sleeping problems (bedtime problems, night wakings and sleepshortage) and of behavioural problems related to sleep. Secundary outcomes are improvement of parenting style, reduction of parenting problems and improvement of well-being and psychosocial problems of the parents (reduction of stress, tiredness, depression). In both studies, the control group receives care-as-usual as offered by the Youth Healthcare organisation.
This study will, in addition to existing knowledge about the treatment of excessive crying in Youth Healthcare, lead to accesible evidence-based interventions for the prevention and treatment of sleepingproblems in young children.
|- Main changes (audit trail)|
|- RECORD||26-apr-2009 - 23-sep-2009|