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

A non-traditional complex intervention for the treatment of paediatric sleep problems - Paediatric sleep problems a different approach

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53773

Enrollment

Registered

2022-05-23

Start date

2023-04-21

Completion date

Unknown

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

self regulation sleep problems sleep problems

Interventions

The AM complex intervention is an existing, expert-based intervention. The choice and composition of the components of the AM complex intervention for the individual child is based on the multi-disc

Eligibility

Age

No minimum to 11 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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 (

Design outcomes

Primary

Measure	Time frame
Primary outcome variables • Sleep duration in per 24 hours (specified in daytime and nighttime)	—

Secondary

Measure	Time frame
Secondary outcome variables: • Sleep factors: o SOL (sleep onset latency), WASO (waking after sleep onset), night awakenings o Crying hours • Child factors: o Self-regulation o Sensory processing o Stress • Parents/ caregivers factors: o Parental perception of the sleeping problem and behaviour: o Parental stress o Parent-child relationship, parenting competence, depressed moods, role limitation and health complaints	—

Measure

Time frame

Secondary outcome variables: • Sleep factors: o SOL (sleep onset latency), WASO (waking after sleep onset), night awakenings o Crying hours • Child factors: o Self-regulation o Sensory processing o Stress • Parents/ caregivers factors: o Parental perception of the sleeping problem and behaviour: o Parental stress o Parent-child relationship, parenting competence, depressed moods, role limitation and health complaints

—

Countries

Netherlands

Contacts

Public ContactN.M.J. Weerts

Universiteit Leiden

n.m.j.weerts@fsw.leidenuniv.nl06-57399913

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)