The impact of toddler screen time in the hour before bed on their sleep and attention Not Applicable
Conditions
Interventions
Current intervention as of 22/07/2022:
The primary aim of the trial is to assess the feasibility of implementing a 7-week Parent-Administered Screen Time Intervention (PASTI), compared with a Bedtime
Sponsors
Birkbeck, University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 22/07/2022: Inclusion criteria will be assessed using a Family Background Pre-screen Questionnaire. Potential participants will be invited to take part in PASTI if they meet the following inclusion criteria: 1. A family with an infant between 16 and 30 months at pre-screening 2. A family that lives in Central/Greater London and surrounding areas (within 75 miles of the Birkbeck Babylab) 3. A family that reports that their infant uses screen time in the hour before bed at pre-screening. They must report that their infant uses =10 minutes of screen time in the hour before bed on =3 days of the week. 4. A caregiver is able to provide informed consent ____ Previous inclusion criteria: Inclusion criteria will be assessed using a Family Background Pre-screen Questionnaire. Potential participants will be invited to take part in PASTI if they meet the following inclusion criteria: 1. A family with an infant between 16 and 18 months at pre-screening 2. A family that lives in Central/Greater London 3. A family that reports that their infant uses screen time in the hour before bed at pre-screening. They must report that their infant uses =10 minutes of screen time in the hour before bed on =3 days of the week. 4. A caregiver is able to provide informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria will be assessed using a Family Background Pre-screen Questionnaire. Potential participants will be excluded if they meet the following criteria: 1. A family with an infant who has a parent-reported genetic or neurological condition (e.g., Downs Syndrome) 2. A family with an infant who was born prematurely (<37 weeks) 3. A family with an infant who is taking part in another trial or research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Participation rates: 1.1. Number consented assessed at week -x to week -2 (pre-screen) 1.2. Number eligible assessed at week -x to week -2 (pre-screen) 1.3. Number probabilistically sampled assessed at week -x to week -2 (pre-screen) 1.4. Number randomised assessed at week 0 2. Recruitment pathways assessed at week -x to week -2 (pre-screen) 3. Intervention adherence in the PASTI Arm measured using the Screen Time Questionnaire and Bedtime Activity Diary over a period of 6 weeks (week 1 – week 6) during the intervention. In the PASTI Arm, the researchers will calculate and describe the average proportion of days with no screen time in the hour before bed, and the average duration of screen use in the hour before bed. These metrics will determine the design features for a future confirmatory study. 4. Participant retention measured using data completion rates at the follow-up lab timepoint (week 7) 5. The acceptability of PASTI measured using the Debrief Questionnaire and Debrief Interview after the follow-up lab timepoint (about week 8) 6. The acceptability of assessments measured using the Debrief Questionnaire and Debrief Interview after the follow-up lab timepoint (about week 8) Metrics of feasibility study acceptability: The researchers have chosen to implement a ‘traffic light’ system to assess the feasibility of implementing a full-scale PASTI trial. Performance metrics that fall in the Red zone indicate that a full trial following the current design may not be feasible, metrics that fall in the Amber zone indicate that a full trial may be feasible but the protocol should be modified or the situation monitored closely, and metrics that fall in the Green zone indicate that a full trial is feasible and the researchers may continue without modifications to the current study design. 1. Randomisation (number of participants randomised overall): a. Red zone: =73 b. Amber zone: 74 to 104 c. Green zone: =105 2. PASTI daily questionnaire completion (% of partic | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/03/2023: Estimates for the following outcomes will be collected: 1. Total infant night-time sleep duration measured using actigraphy at baseline (weeks -1 and 0; pre-randomisation) and follow up (weeks 6 and 7) 2. Exogenous attention control measured using single search saccadic reaction time from the Visual Search Task at baseline (week 0; pre-randomisation) and follow up (week 7) 3. Average toddler screen use (minutes) in the hour before bed measured through one weekday and one weekend bi-weekly bedtime activity diary directly preceding the lab-based assessment at baseline (weeks -1 and 0; pre-randomisation) and follow up (weeks 6 and 7) 4. Additional sleep outcomes: 4.1. Average nap duration measured using actigraphy at baseline (weeks -1 and 0; pre-randomisation) and follow up (weeks 6 and 7) 4.2. Frequency of night awakenings measured using actigraphy at baseline (weeks -1 and 0; pre-randomisation) and follow up (weeks 6 and 7) 4.3. Sleep efficiency measured using actigraphy at baseline (weeks -1 and 0; pre-randomisation) and follow up (weeks 6 and 7). 4.4. Parent-reported sleep onset latency measured using the Brief Infant Sleep Questionnaire – Revised (BISQ-R) at baseline (week -1; pre-randomisation) and follow up (week 6) 5. Additional attention control outcomes: 5.1. Prosaccade saccadic reaction time and proportion of antisaccades measured using the Antisaccade Task at baseline (week 0; pre-randomisation) and follow up (week 7) 5.2. Baseline saccadic reaction time and disengagement saccadic reaction time measured using the Gap-Overlap Task at baseline (week 0; pre-randomisation) and follow up (week 7) 5.3. Parent-reported effortful control and inhibitory control measured using the Early Childhood Behaviour Questionnaire (ECBQ) at baseline (week -1; pre-randomisation) and follow up (week 6) _____ Previous secondary outcome measures: Estimates for the following outcomes will be collected: 1. Total infant n | — |
Countries
England, United Kingdom
Outcome results
None listed