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Sleep Resource for Carers of Pre-school Aged Children; a Development and Pilot Study

NCT05097703 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-05-15

No results posted yet for this study

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.

Conditions

  • Sleep Hygiene

Interventions

BEHAVIORAL

Sleep Resource

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

Sponsors & Collaborators

  • University of Surrey

    lead OTHER

Principal Investigators

  • Alex J Tapping, BSc MSc · University of Surrey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2022-12-31
Completion
2023-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05097703 on ClinicalTrials.gov