Sleep Support for Children With Neurodevelopmental Disorders

Can a Supportive Sleep-Practitioner-led Intervention Lead to Improved Sleep, Wellbeing and Reduced Medication Prescribing for Children With Neurodevelopmental Disorders and Co-occurring Severe Sleep Difficulties?

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Wake Disorders; Sleep Hygiene
• Intervention / Treatment: Behavioral: Behavioural sleep clinic access

Detailed Description

Sleep is a restorative process, fundamental to physical and psychological health. Sleep disturbances including bedtime resistance and night-time awakening occur in 80% children with neurodisability, the most common associations being with Attention Deficit Hyperactivity Disorder (ADHD), Autism, cerebral palsy and syndromes such as Down, Prader-Willi and Angelman syndromes. In a meta-analysis of subjective and objective studies found that ADHD is associated with higher bedtime resistance, sleep-onset difficulty and longer latency, night awakenings, trouble waking up in the morning, sleep-disordered breathing, daytime sleepiness, more shifts between sleep stages, lower sleep efficiency and less sleep time. Anxiety and depression symptoms may have a significant role in the prevalence of sleep difficulties which would be clearly observed in bedtime resistance, sleep anxiety, night time awakenings and sleep onset delay. Thus, teaching children how to develop sleep hygiene and the use of behavioural modification to manage their fears would help children to fall asleep easily and reduce bedtime resistance which therefore would improve sleep quantity and quality.

The impact of sleep disturbance on children's health is wide-ranging with sleep deprivation leading to difficulties with mood, psychosocial problems and a detrimental impact on the child's cognitive ability and learning. Parents of children with sleep difficulties can suffer high levels of stress and anxiety, decreased ability to work or to drive safely, relationship and financial problems. These stresses lead to an increased demand on NHS primary care services and to prescriptions of drugs such as antidepressants. Children with significant sleep difficulties in the UK are often treated with melatonin, a hormone playing a key role in the timing of sleep-wake cycle, despite the findings of a recent systematic review that suggest that evidence does not strongly support its use. The drug is costly to the health service, with individual Clinical Commissioning Groups (CCGs) spending up to £500k per year on prescription charges for this drug alone.

Evidence from sleep clinics delivered in the local authority, NHS and voluntary sectors has shown that an intensive sleep support intervention can be highly effective. A recent retrospective evaluation of a nurse-led sleep support service successfully discharged 63% children without melatonin prescriptions after a median of two face-to face visits and three telephone calls. The proposed study will aim to support children with neurodevelopmental problems taking melatonin for sleep difficulties to develop long-term strategies for promoting sleep and to reduce drug prescriptions.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Elphick; Phone Number: 01142 717000; Email: h.elphick@nhs.net

Study Locations

• United Kingdom
  • Sheffield, United Kingdom
    • Recruiting
    • Clinical Research Facility, Sheffield Children's Hospital
    • Contact: Heather Elphick; Phone Number: 0114 2717000; Email: h.elphick@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children to be included will fulfil all of the inclusion criteria.

  • 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

Exclusion Criteria:

• Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Access to Sleep Clinic immediately	Behavioral: Behavioural sleep clinic access; Access to behavioural Sleep Clinic
Experimental: Control; Access to Sleep Clinic delayed	Behavioral: Behavioural sleep clinic access; Access to behavioural Sleep Clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strengths and Difficulties Questionnaire (SDQ)	Strengths and Difficulties Questionnaire (SDQ)	20 weeks
CHU-9D Quality of Life questionnaire	CHU-9D Quality of Life questionnaire	20 weeks
Healthcare Utilisation	Questionnaire (designed by researchers) recording how many times patient has accessed healthcare settings/professionals in last year	20 weeks
Parent Wellbeing	Warwick- Edinburgh Mental Wellbeing Scale	20 weeks

Collaborators and Investigators

• Sponsor: Sheffield Children's NHS Foundation Trust
• Investigators: Study Director: Heather Elphick, Sheffield Children's NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: SCH-2530

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No