Storybook App vs Cognitive Behavioral Therapy for Child Sleep and Attachment
NCT07668609 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-07-06
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.
Conditions
- Pediatric Sleep Problems
- Sleep Hygiene
- Parent-Child Attachment
Interventions
- BEHAVIORAL
-
CBT-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.
- BEHAVIORAL
-
Storybook 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 & Collaborators
-
Universidad Católica de Cuenca
lead OTHER
Principal Investigators
-
Juan P Viñanzaca López, MSc · Universidad Católica de Cuenca
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Months
- Max Age
- 84 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-12
- Primary Completion
- 2024-06-20
- Completion
- 2024-06-20
Countries
- Ecuador
Study Locations
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