CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Sleep Resourcebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05097703
NCT05097703N/ACompleted

The Development and Pilot of a Sleep Resource for Carers of Pre-school Aged Children to be Used as Part of the Bedtime Routine

University of Surrey·interventional·Posted Oct 28, 2021·Updated May 15, 2023

In Brief

A clinical study evaluating Sleep Resource for Sleep Hygiene. Completed, enrolled 44 participants across 1 site.

Detailed Summary

Evidence suggests sleep difficulties in pre-school children (aged 3-6 years) are highly prevalent and that carer knowledge of good sleep hygiene practices and the importance of them is relatively poor. Establishing a regular bedtime routine, involving activities shown to induce relaxation and prepare the child for sleep, is important in promoting optimal sleep duration and quality. However, there appears to be a lack of evidence-based resources that are empirically evaluated for carers to use with children within the family home. This study proposes to co-develop and pilot a new sleep resource. This will be an interactive storybook which guides children and their carers through a number of activities, designed to increase relaxation and prepare the child for sleep. A randomised control trial (RCT) design will be used, with an intervention group and a waitlist control group who will receive the resource at the end of the intervention period. Both groups will be asked to complete pre-intervention, post-intervention and follow-up measures; as well as keep sleep diaries for their children for the duration of the intervention period. The intervention group will also be asked to keep a diary of resource use and then to complete a feedback survey post-intervention. They will be asked to use the resource for a minimum of three days a week for a one-month period. This pilot aims to assess the acceptability of the resource and provide initial findings in terms of its efficacy on a range of sleep related outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Hygiene
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 28, 2021
Enrollment StartNov 29, 2021
Primary CompletionDec 31, 2022
Study CompletionJan 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.7 years ago

Interventions

Sleep Resourcebehavioral

The sleep resource is a card game to be played by children and caregivers as part of their bedtime routine. It includes exercises to help prepare the child for sleep, including deep breathing, mindfulness and light movement. Caregivers will be asked to use the resource for a minimum of three nights a week over a four week period, and complete pre and post outcome measures as well as sleep and resource use diaries for their children