This completed randomized controlled trial compared two caregiver-delivered interventions for sleep in young children: a multimodal mobile health intervention delivered through the Storybook mobile application and a face-to-face psychoeducational intervention based on cognitive behavioral therapy principles. The study was conducted in Azuay Province, Ecuador.

Children aged 12 to 84 months were randomly assigned to one of two groups. In the Storybook group, caregivers used the mobile application at home for 40 minutes per day for 1 month. The application guided caregivers through calming bedtime activities, including guided massage, audio stories, and music. In the comparison group, caregivers received eight 40-minute face-to-face psychoeducational sessions over the same 1-month period. These sessions focused on sleep hygiene and behavioral strategies, including consistent bedtime routines, positive reinforcement, and management of disruptive pre-sleep behaviors.

The study assessed whether the Storybook application and the cognitive behavioral therapy-based psychoeducational intervention were associated with changes in child sleep quantity, sleep quality, and parent-child attachment. Sleep and attachment were assessed before and after the intervention using standardized questionnaires and an attachment assessment.

Sleep regulation and the parent-child relationship are important components of early childhood development. Pediatric sleep problems may affect child behavior, family routines, and caregiver well-being. However, access to specialized face-to-face psychological care may be limited in some settings. Mobile health interventions may offer an accessible way to support caregivers at home, but they require evaluation against evidence-based approaches.

This study was a completed, two-arm, parallel-group randomized controlled trial with baseline and postintervention assessments. The trial evaluated a caregiver-mediated mobile health intervention delivered through the Storybook mobile application compared with a cognitive behavioral therapy-based psychoeducational intervention. The study was conducted in Azuay Province, Ecuador.

Participants were children aged 12 to 84 months whose legal guardians provided written informed consent. Seventy-one children were assessed at baseline. Of these, 60 children were randomized and assigned to one of two intervention groups: 31 to the Storybook mobile application group and 29 to the CBT-based psychoeducation group. All randomized participants completed the intervention and postintervention assessment procedures and were included in the final analytic sample.

The Storybook intervention consisted of caregiver-led use of the mobile application at home for 40 minutes per day over 1 month. Caregivers received instructions on how to use the application with the child. The application included guided massage, auditory narration, and music, with the aim of supporting a calm bedtime routine and caregiver-child interaction.

The active comparator consisted of eight face-to-face psychoeducational sessions based on cognitive behavioral therapy principles. Each session lasted approximately 40 minutes, and sessions were delivered twice weekly over 1 month. The sessions were directed to legal guardians and focused on behavioral strategies for child sleep, including sleep hygiene, consistent bedtime routines, positive reinforcement, and management of disruptive pre-sleep behaviors.

The main areas of assessment were child sleep quantity, child sleep quality, and parent-child attachment. Assessments were conducted at baseline and after completion of the 1-month intervention period. Sleep outcomes were assessed using the Brief Infant Sleep Questionnaire and the BEARS Sleep Screening Tool. Parent-child attachment was assessed using the Attachment Q-Set. Statistical analyses compared baseline and postintervention values within each group and postintervention outcomes between groups, using parametric or nonparametric procedures according to the distribution and measurement level of each variable.

Inclusion Criteria:

• Children aged 12 to 84 months.
• Residence in urban or rural areas of Cuenca, Azuay Province, Ecuador.
• Written informed consent provided by the child's legal guardian.
• Availability of the legal guardian to participate in the assigned intervention and complete baseline and postintervention assessments.
• Availability to complete the study procedures during the 1-month intervention period.

Exclusion Criteria:

• Children with a previous diagnosis of a neurodevelopmental disorder.
• Children with a chronic medical condition that, according to caregiver report or available clinical information, could affect sleep.
• Children with a clinical history of severe sleep disturbances requiring specialized medical or psychological treatment.
• Children or caregivers who were unable to complete the baseline or postintervention assessments.

De-identified individual participant data underlying the reported study results may be shared. The shared dataset may include study group assignment, baseline sociodemographic variables, and de-identified outcome data from the Brief Infant Sleep Questionnaire, the BEARS Sleep Screening Tool, and the Attachment Q-Set. No names, identification numbers, contact information, signed consent forms, or other directly identifiable participant information will be shared.

Data and supporting information may be requested beginning 6 months after publication of the main study results and will remain available for 5 years.

De-identified data may be shared with qualified researchers who submit a methodologically sound proposal for secondary analysis. Requests should be directed to the corresponding author and will be reviewed by the study investigators. Access will be subject to institutional ethics requirements and, when applicable, approval by the relevant ethics committee. Data will be shared only after approval of the request and completion of an appropriate data use agreement.