None listed
Conditions
Brief summary
Despite how common and impactful child sleep problems are, they are not routinely treated within public hospital outpatient services, and there is a shortage of professionals trained in paediatric sleep. Our team has developed the Lights Out program, a caregiver-directed intervention that teaches practical strategies to manage child sleep problems. Research has shown that Lights Out improves children’s sleep, anxiety, and behaviour, as well as caregiver wellbeing, and can be delivered face-to-face or via videoconference. This study responds to an urgent request from Queensland’s two largest public hospital paediatric outpatient services to adapt the Lights Out program for routine care. Caregivers of children aged 3-to-12 years with sleep problems will be recruited from two paediatric outpatient clinics. Families will be randomly assigned to receive either the Lights Out program or usual care. Child sleep and wellbeing, as well as caregiver wellbeing, will be assessed over six months. The study will also examine how acceptable the program is for families and clinicians to support wider delivery in public health settings.
Interventions
A caregiver-focused behavioural sleep intervention adapted for delivery via group-based videoconference sessions will be implemented in the paediatric outpatient services. The group size and the number of sessions will be determined through a stakeholder-informed adaptation process before the trial starts. This phase of the project will involve qualitative interviews with key stakeholders (caregivers, hospital clinicians and administrators) to gather their perspectives and recommendations to inf
A caregiver-focused behavioural sleep intervention adapted for delivery via group-based videoconference sessions will be implemented in the paediatric outpatient services. The group size and the number of sessions will be determined through a stakeholder-informed adaptation process before the trial starts. This phase of the project will involve qualitative interviews with key stakeholders (caregivers, hospital clinicians and administrators) to gather their perspectives and recommendations to inform adaptation of the Lights Out program for paediatric outpatient settings. Interview sessions will focus on gathering participant perspectives on: • the preferred delivery format of the program; • presentation and accessibility of program content; • practical considerations for use within paediatric outpatient services; and • perceived barriers and facilitators to program delivery. Participants may take part in the adaptation process through either group or individual interviews, depending on their availability and preference. Interviews should take approximately 30 minutes in an individual format or 60-90 minutes in a group format. The original Lights Out program (Donovan et al., 2023) incorporates standard paediatric sleep strategies alongside gold standard treatment strategies targeting bedtime fears (i.e. exposure hierarchies) and behavioural problems at bedtime (i.e., clear instructions, time-out, and limit-setting). Caregivers are trained to support their child in gradually managing bedtime fears through the Lights Out Ladder, which involves collaboratively developing a graded exposure hierarchy. The Lights Out Ladder is a step-by-step plan designed to gradually reduce fear. It involves listing situations that trigger fear, ranking them from least to most fearful, and then helping the child face these situations progressively. The original program was delivered weekly over 6 weeks and comprised of five 1.5-hour face-to-face group sessions. For the purposes of current trial, Lights Out Modified (LOM) will be delivered via group-based videoconference sessions using Microsoft Teams, reflecting the service delivery constraints of the participating hospitals. Sessions will be delivered to caregivers only (children will not attend). Consistent with the original program, LOM will follow a structured, manualised program based on cognitive-behavioural therapy principles. The program will include psychoeducation on sleep and sleep hygiene; will provide training in sleep routines, bedtime fading, praise and rewards; will teach strategies for dealing with night-time fears and for dealing with difficult behaviours. Two developmentally appropriate versions of the program will be delivered: one for caregivers of children aged 3-6 years and one for caregivers of children aged 7-12 years. LOM groups will be facilitated by provisionally registered psychologists external to the hospital (i.e., trial therapists). All trial therapists will receive standardised training (minimum of 5 hours) in the LOM protocol delivered by Principal Investigator Donovan prior to commencing intervention delivery. Trial therapists will also participate in weekly 2-hour group supervision sessions led by the members of the investigative team who are fully registered Clinical Psychologists (Donovan, Farrell, and Winter), throughout the intervention period. Session attendance and homework adherence will be monitored and recorded by the LOM group therapists for each participant. All treatment sessions will be video-taped and independently assessed for treatment fidelity.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Caregivers: To be included in the study, caregiver participants must meet the following criteria: • Be a parent or legal guardian aged 18 years or older. • Be able to provide informed consent and participate in the intervention and study procedures. • Have at least one child with a developmental age between 3 and 12 years who is accessing (on the waitlist or currently receiving) paediatric outpatient services at study sites. • The child must score 41 or higher on the CSHQ, indicating clinically significant behavioural child sleep problems that are not primarily respiratory in nature. Trial therapists: To be eligible to participate in the program satisfaction and acceptability survey, trial therapists must meet the following criteria: • Be aged 18 or over. • Be a registered or provisionally registered Psychologists external to the hospital services. • Have received standardised training (minimum of 5 hours) in the LOM protocol delivered by Principal Investigator Donovan prior to commencing intervention delivery and participated in weekly 2-hour group supervision sessions led by the investigative team. • Have delivered the full LOM program to least one LOM group during the trial.
Exclusion criteria
Caregiver participants will be excluded from the study if any of the following apply: • The caregiver is unable to provide informed consent due to limited understanding or comprehension of the study procedures. • The caregiver does not have sufficient English proficiency to complete study measures or participate in the intervention, and an interpreter is not available. • The child has a diagnosed or suspected primary sleep disorder of respiratory origin (e.g., obstructive sleep apnoea), as indicated by clinical history or screening responses. • The child has a diagnosed intellectual or developmental disability that would significantly limit their caregiver’s ability to engage with the intervention content, as indicated by clinical history or screening responses. • The child is currently receiving psychological or psychiatric treatment specifically targeting sleep problems that would conflict with participation in the study. • The child has commenced or had changes to sleep-related or psychotropic medication within the six weeks prior to enrolment, such that medication effects are not yet stabilised. The trial therapists will be excluded from participating if they: • Did not actively engage in the delivery of LOM.
Outcome results
None listed