A non-traditional complex intervention for the treatment of paediatric sleep problems
Recruiting
- Conditions
- ontwikkelingsstoornissen van het jonge kindself regulationsleep problems
- Registration Number
- NL-OMON53773
- Lead Sponsor
- niversiteit Leiden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
• Children aged 6-36 months
• Category sleep problems *Insomnia* (ICSD-3): sleep onset latency, sleep
maintenance problems or a
combination of both
• One or more signs of dysregulation (excessive crying, unwilling to eat and
sleep and inability to state
regulation)
Exclusion Criteria
• Other diagnostic sleep categories according to the ICSD-3
• Diagnosed comorbidity provoking sleep problems (e.g., ENT, pain, trauma,
itch, cancer)
• Genetic disorder or neurodevelopmental disorder
• History of prematurity (<37 weeks gestational age)
• Former complex intervention for sleeping problems
• Former behavioural interventions for sleeping problems
• Untreated gastroesophageal reflux (GER) or symptoms of food intolerances or
allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome variables<br /><br>• Sleep duration in per 24 hours (specified in daytime and nighttime)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome variables:<br /><br><br /><br>• Sleep factors:<br /><br>o SOL (sleep onset latency), WASO (waking after sleep onset), night awakenings<br /><br>o Crying hours<br /><br><br /><br>• Child factors:<br /><br>o Self-regulation<br /><br>o Sensory processing<br /><br>o Stress<br /><br><br /><br>• Parents/ caregivers factors:<br /><br>o Parental perception of the sleeping problem and behaviour:<br /><br>o Parental stress<br /><br>o Parent-child relationship, parenting competence, depressed moods, role<br /><br>limitation and health complaints</p><br>