A non-traditional complex intervention for the treatment of paediatric sleep problems.

Recruiting

• Conditions: Ontwikkelingsstoornissen van het jonge kind; self regulation; sleep problems

• Registration Number: NL-OMON52044
• Lead Sponsor: niversiteit Leiden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Children aged 6-36 months.
Sleep problems; according to the ICSD-3, Insomnia type behavioural; specified
to sleep onset, sleep maintenance or a combination of both.
One or more signs of dysregulation (crying, unwilling to eat and sleep and
inability to state regulation).

Exclusion Criteria

Other diagnostic sleep categories according to the ICSD-3
Earlier diagnosed comorbidity provoking sleep problems (e.g. pain, trauma,
itch, cancer)
Genetic syndrome
Prematurity (<37 weeks gestural age)
Former IM treatment for sleep problems
Former professional behavioural interventions for sleep problems
Untreated gastroesophageal reflux (GER) or untreated symptoms of food
intolerances/ allergy

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Outcome variables<br /><br><br /><br>The feasibility study<br /><br>Stage 1:<br /><br>The feasibility of methods and instruments<br /><br>The possible dropout of participants and reason, if given<br /><br>Preferred treatment outcomes by parents/ caregivers<br /><br>The feasibility of the use of the TIDieR guideline by health professionals and<br /><br>possible reasons for not completing all questions<br /><br>The number of included participants per week and its origin of referral</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>