Examining the feasibility of carrying out a parent-administered screen time intervention in toddlers

INTERVENTION: 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 Box Intervention and No Intervention, in 18‐month‐old infants who have parent‐reported screen time in the hour before bed. Participants will be randomised (1:1:1 allocation ratio) at the end of the baseline lab visit in a web‐based randomisation system using minimisation with respect to child age, child sex, and family socioeconomic status (using the Index of Multiple Deprivation). PASTI arm: In the PASTI arm caregivers are required to remove screen time in the hour before bed from their 18‐month‐old (range 17 – 19 months) child. The PASTI is modelled on effective parent‐education screen time interventions in older children (e.g. a 7‐week intervention). A cover story for PASTI will be used to obscure the role of screen time to avoid self‐selection of families interested in the topic and to minimise bias in caregiver‐reported screen use across the intervention arms. As such, families will be recruited into our trial on toddler bedtime activities in the hour before bed (for full trial details, please see the trial protocol: https://osf.io/vnt6k/?view_only=6b4ec27564ef45a2a3cb3c1d4f9eee32). At the start of the intervention, families will receive a booklet to educate them on “No screen time in the hour before bed” and a Family Bedtime Box with tips on alternative pre‐bed activities to help them displace screen time in the hour before bed (e.g., activity cards with fun bath games, story time ideas, as well as a selection of age‐appropriate toys, such as crayons, a bath toy, puzzle etc). The activity cards for the PASTI arm contain a no screen time symbol, as well as s CONDITION: The impact of toddler screen time in the hour before bed on their sleep and attention ; Not Applicable SECONDARY OUTCOME: ; 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. 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); PRIMARY OUTCOME: ; 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 participants randomised to PASTI and retained to lab follow up that complete =60% of daily screen time questionnaires):; a. Red zone: <65%; b. Amber zone: 65% to 79%; c. Green zone: =80%; ; 3. PASTI adherence to screen time removal (week 1 – week 6) (% of participants randomised to PASTI that report no screen time on =60% of daily screen time questionnaires completed):; a. Red zone: <50%; b. Amber zone: 50% to 69%; c. Green zone: =70%; ; 4. Retention (% of randomised participants attending follow‐up Lab visit):; a. Red zone: <70%; b. Amber zone: 70% to 74%; c. Green zone: =75%; ; 5. PASTI debrief questionnaire completion (% of participants randomised to PASTI that complete the debrief questionnaire measuring participant experience and assessment acceptability):; a. Red zone: <65%; b. Amber zone: 65% to 74%; c. Green zone: =75%; 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