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

NCT05097703 | Completed DMC

• 1 other identifier: FHMS 20-21 172 EGA
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sleep intervention; Pre-school children; Caregivers

Outcome Measures

Primary Outcomes (3)

• Change in Carer reported child sleep diaries

  Carer to fill out sleep diary for child every day for four week period. To include time put to bed, time taken to fall asleep, frequency and duration of night time awakenings and time woke in morning.

  4 week period from baseline

• Change in Resource use diaries

  Carer to fill out for child every day for four week period. To include time started using resource, length of time playing and the setting played in (e.g. bedroom, lounge).

  4 week period from baseline

• Outcome of Feedback survey

  Intervention group carers to complete feedback survey on the acceptability and utility of the resource. To include quantitative and qualitative feedback.

  1 month

Secondary Outcomes (5)

• Change in Children's Sleep-Wake Scale (CSWS) (LeBourgeois & Harsh, 2016)

  Baseline, 1 month and 2 month post follow ups

• Change in General Sleep Information (GSI) (Akacem, Wright & LeBourgeois, 2016)

  Baseline, 1 month and 2 month post follow ups

• Change in Strengths and Difficulties Questionnaire, parent version (SDQ) (Goodman, 1997)

  Baseline, 1 month and 2 month post follow ups

• Change in Parenting Stress Scale (PSS) (Berry & Jones, 1995)

  Baseline, 1 month and 2 month post follow ups

• Change in Parent-Child Sleep Interactions Scale (PCSIS) (Alfano, Smith, Reynolds, Reddy & Dougherty, 2013)

  Baseline, 1 month and 2 month post follow ups

Other Outcomes (1)

• Demographics

  Baseline

Study Arms (2)

Sleep Resource Intervention

EXPERIMENTAL

Half the participants in the study will be allocated to the intervention group. The resource will be sent to participants in this group, along with information about the research study and instructions for completing outcome measures. This will be followed up by a telephone call to ensure participants understand what is required of them and to answer any questions. All carers will be asked to complete questionnaires at baseline, immediately post intervention and at one-month post intervention; as well as sleep diaries for their child for the duration of the intervention period. Carers in the intervention group will also be asked to complete a diary of resource use as well as a feedback survey on their experience of using the resource. Carers in the intervention group will be asked that they use the resource with their child at bedtime for a minimum of three-days a week over a one-month period.

Behavioral: Sleep Resource

Control

NO INTERVENTION

Participants randomised to the wait-list control group will be asked to complete pre, post and follow-up measures, as well as keep a sleep diary for the duration of the intervention period. They will then be sent the resource after the final outcome measures have been collected to use as they wish.

Interventions

Sleep Resource BEHAVIORAL

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

Sleep Resource Intervention

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Carer-child dyads (3-6 years old) who feel their child could benefit from a resource designed to improve sleep outcomes.
• Fluent in English.
• Carers must hold legal parental responsibility for the child taking part in the study with them and be able to provide consent on their behalf.

You may not qualify if:

• Children who have a diagnosis of neurological disorder, cardiovascular or genetic diseases.
• Carers and or child unable to understand English.
• Carers who are not regularly available to assist children with the bedtime routine (e.g. do not live in the family home).

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (1)

Alex Tapping

Guildford, Surrey, GU2 7XH, United Kingdom

Location

Related Publications (28)

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Related Links

• Sleep Council recommendations

MeSH Terms

Conditions

Sleep Hygiene

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Alex J Tapping, BSc MSc

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participant randomly assigned to either an intervention arm or control arm. Intervention arm will receive the sleep resource and be asked to use it over a 4 week period where as the control group will not.

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 28, 2021
• Study Start: November 29, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)