Sleep Support for Children With Neurodevelopmental Disorders

NCT05971212 | Unknown

• 1 other identifier: SCH-2530
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Around 80% of children with neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD) and autism are reported to have significant difficulties with sleep. This may be a problem with settling off to sleep, waking repeatedly in the night, or both. Often these children will be prescribed a medication called melatonin to help them sleep, but there is no strong evidence of its effectiveness in children, the long-term side effects are not known and prescriptions for this drug cost millions of pounds a year for the NHS. Many children continue to have persistent sleep problems despite taking melatonin. Sleep support programmes delivered by nurses and sleep practitioners are known to be effective and to give parents and young people long-term strategies for promoting sleep without the use of medication. However, sleep support services are not universally funded. In this feasibility study 76 children with ADHD, autism or other neurodevelopmental disorder who have been prescribed and have been regularly taking melatonin for at least a year but still have severe sleep difficulties will be recruited. The investigators will help to improve the child's sleep with a sleep practitioner support programme and, if possible, reduce the dose of melatonin or stop it completely if it is no longer needed. Using this design, it will be possible to test whether a programme delivered by sleep practitioners will significantly improve sleep for children using a non-medical approach and in turn improve the health and well-being of the child and family and reduce melatonin prescribing, thereby saving NHS resources and the potential for long-term side effects. The study design will be delivered by Sheffield Children's Hospital and supported by parent users, the Sleep Charity and Sheffield CCG. The results will be disseminated widely to local, regional and national groups as well as via social media.

Conditions

Sleep Hygiene; Sleep Wake Disorders

Outcome Measures

Primary Outcomes (4)

• Sleep Diary

  7 day sleep diary (parent report)

  20 weeks

• Actiwatch data

  Actiwatch worn for a 7 day period

  20 weeks

• Child Sleep Habits Questionnaire (CSHQ)

  Child Sleep Habits Questionnaire (CSHQ)

  20 weeks

• Melatonin Prescription Status

  Questionnaire (designed by researchers) asking about patient dosage and type of melatonin taken

  20 weeks

Secondary Outcomes (4)

• Strengths and Difficulties Questionnaire (SDQ)

  20 weeks

• CHU-9D Quality of Life questionnaire

  20 weeks

• Healthcare Utilisation

  20 weeks

• Parent Wellbeing

  20 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Access to Sleep Clinic immediately

Behavioral: Behavioural sleep clinic access

Control

EXPERIMENTAL

Access to Sleep Clinic delayed

Behavioral: Behavioural sleep clinic access

Interventions

Behavioural sleep clinic access BEHAVIORAL

Access to behavioural Sleep Clinic

Control; Intervention

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Formal diagnosis of ADHD, autism or another neurodevelopmental condition,
• Age 4-11 years,
• Severe sleep disturbance (defined as Score of 3 or more on Composite Sleep Disturbance Index),
• Been taking melatonin to aid sleep onset for more than 12 months

You may not qualify if:

• Already accessed a sleep clinic at Sheffield Children's Hospital or The Sleep Charity.
• English not first language

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Clinical Research Facility, Sheffield Children's Hospital

Sheffield, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sleep Hygiene; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Heather Elphick

  Sheffield Children's NHS Trust

  STUDY DIRECTOR

Central Study Contacts

Heather Elphick

CONTACT

01142 717000; h.elphick@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: August 2, 2023
• Study Start: January 29, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)