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Completed
NCT07668609
Storybook App vs Cognitive Behavioral Therapy for Child Sleep and Attachment
Conditions: Pediatric Sleep Problems, Sleep Hygiene, Parent-Child Attachment
Sex: All
Ages: 12 Months – 84 Months
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Universidad Católica de Cuenca
Location: Universidad Católica de Cuenca Cuenca Azuay
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07668609). StuddyBuddy aggregates publicly available trial information.