Parent-Child Attachment, Pediatric Sleep Problems, Sleep Hygiene
Conditions
Keywords
pediatric sleep, child sleep, sleep quality, sleep quantity, sleep hygiene, sleep onset latency, night wakings, nocturnal awakenings, bedtime problems, parent-child attachment, parent-child relationship, early childhood, mobile health, mHealth, mobile application, Storybook application, cognitive behavioral therapy, CBT, psychoeducation, caregiver-mediated intervention, infant massage, bedtime routine, Brief Infant Sleep Questionnaire, BISQ, BEARS Sleep Screening Tool, Attachment Q-Set, AQS, randomized controlled trial, Ecuador
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCBT-Based Psychoeducational Intervention
Caregivers received eight 40-minute face-to-face psychoeducational sessions over 1 month. Sessions were delivered twice weekly and were based on cognitive behavioral therapy principles. The intervention focused on behavioral strategies for child sleep, including sleep hygiene, consistent bedtime routines, positive reinforcement, and management of disruptive pre-sleep behaviors.
BEHAVIORALStorybook Mobile Application Intervention
Caregivers used the Storybook mobile application at home with the child for 40 minutes per day over 1 month. The intervention included caregiver-led reading, guided massage, and affection-based activities delivered through the application to support bedtime routines, child sleep initiation, and caregiver-child interaction.
Sponsors
Universidad Católica de Cuenca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm, parallel-group randomized controlled trial. Participants were assigned to either a cognitive behavioral therapy-based psychoeducational intervention or a multimodal mHealth intervention delivered through the Storybook mobile application. Outcomes were assessed at baseline and after the 1-month intervention period.
Eligibility
Sex/Gender
ALL
Age
12 Months to 84 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Nocturnal Sleep Duration | Baseline and immediately after the 1-month intervention period | Nocturnal sleep duration was assessed using the Brief Infant Sleep Questionnaire. The outcome was measured in minutes and calculated as the difference between the baseline assessment and the postintervention assessment. Higher values indicate longer nocturnal sleep duration. |
| Change From Baseline in Sleep Onset Latency | Baseline and immediately after the 1-month intervention period | Sleep onset latency was assessed using the Brief Infant Sleep Questionnaire. The outcome was measured in minutes and calculated as the difference between the baseline assessment and the postintervention assessment. Higher values indicate a longer time required for the child to fall asleep. |
| Change From Baseline in Number of Night Wakings | Baseline and immediately after the 1-month intervention period | The number of night wakings was assessed using the Brief Infant Sleep Questionnaire. The outcome was measured as the caregiver-reported number of nocturnal awakenings and calculated as the difference between the baseline assessment and the postintervention assessment. Higher values indicate more frequent night wakings. |
| Change From Baseline in Parent-Child Attachment Score | Baseline and immediately after the 1-month intervention period | Parent-child attachment was assessed using the Attachment Q-Set, Spanish culturally adapted version, as a study-specific raw summed attachment security score; total scores range from 0 to 450, with higher scores indicating greater parent-child attachment security according to the scoring procedure used in this study, and the outcome was calculated as the post-intervention raw total score minus the baseline raw total score, with higher positive change values indicating a more favorable outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Daytime Sleep Duration | Baseline and immediately after the 1-month intervention period | Daytime sleep duration was assessed using the Brief Infant Sleep Questionnaire. The outcome was measured in minutes and calculated as the difference between the baseline assessment and the postintervention assessment. Higher values indicate longer daytime sleep duration. |
| Change From Baseline in Nocturnal Wakefulness | Baseline and immediately after the 1-month intervention period | Nocturnal wakefulness was assessed using the Brief Infant Sleep Questionnaire. The outcome was measured in minutes and calculated as the difference between the baseline assessment and the postintervention assessment. Higher values indicate longer wakefulness during the night. |
| Change From Baseline in BEARS Sleep Screening Domains | Baseline and immediately after the 1-month intervention period | Sleep quality indicators were assessed using the BEARS Sleep Screening Tool. The assessed domains were bedtime problems, excessive daytime sleepiness, awakenings during the night, regularity and duration of sleep, and snoring. Each domain was recorded as present or absent at baseline and after the intervention. |
Countries
Ecuador
Contacts
PRINCIPAL_INVESTIGATORJuan P Viñanzaca López, MSc
Universidad Católica de Cuenca
Outcome results
None listed