Storybook App vs Cognitive Behavioral Therapy for Child Sleep and Attachment (STORYBOOK-RCT)

Comparative Effects of a Multimodal mHealth Intervention Versus Cognitive Behavioral Therapy for Pediatric Sleep and Parent-Child Attachment: Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Sleep Hygiene; Pediatric Sleep Problems; Parent-Child Attachment
• Intervention / Treatment: Behavioral: CBT-Based Psychoeducational Intervention; Behavioral: Storybook Mobile Application Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ecuador
  • Azuay
    • Cuenca, Azuay, Ecuador, 010101
      • Universidad Católica de Cuenca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CBT-Based Psychoeducation; Child-caregiver dyads randomized to the active comparator group. Caregivers received eight 40-minute face-to-face psychoeducational sessions over 1 month. Sessions were based on cognitive behavioral therapy principles and focused on child sleep hygiene, consistent bedtime routines, positive reinforcement, and management of disruptive pre-sleep behaviors.	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.; Other Names: Cognitive Behavioral Therapy-Based Psychoeducation; CBT Sleep Psychoeducation
Experimental: Storybook Mobile Application; Child-caregiver dyads randomized to the experimental mobile health intervention group. Caregivers used the Storybook mobile application at home with the child for 40 minutes per day over 1 month. The application included reading, massage, and affection-based activities intended to support bedtime routines, child sleep initiation, and caregiver-child interaction.	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.; Other Names: Storybook App; Storybook mHealth Intervention; Multimodal mHealth Sleep Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Nocturnal Sleep Duration	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.	Baseline and immediately after the 1-month intervention period
Change From Baseline in Sleep Onset Latency	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.	Baseline and immediately after the 1-month intervention period
Change From Baseline in Number of Night Wakings	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.	Baseline and immediately after the 1-month intervention period
Change From Baseline in Parent-Child Attachment Score	Parent-child attachment was assessed using the Attachment Q-Set. The outcome was calculated as the difference between the baseline attachment score and the postintervention attachment score. Higher scores indicate greater attachment security according to the scoring procedure used in the study.	Baseline and immediately after the 1-month intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Daytime Sleep Duration	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.	Baseline and immediately after the 1-month intervention period
Change From Baseline in Nocturnal Wakefulness	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.	Baseline and immediately after the 1-month intervention period
Change From Baseline in BEARS Sleep Screening Domains	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.	Baseline and immediately after the 1-month intervention period

Collaborators and Investigators

• Sponsor: Universidad Católica de Cuenca
• Investigators: Principal Investigator: Juan P Viñanzaca López, MSc, Universidad Católica de Cuenca

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: June 19, 2026
• First Submitted That Met QC Criteria: June 19, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; mobile health; cognitive behavioral therapy; mHealth; CBT; sleep hygiene; sleep quality; mobile application; psychoeducation; Ecuador; infant massage; parent-child relationship; early childhood; sleep onset latency; sleep quantity; bedtime routine; pediatric sleep; child sleep; night wakings; nocturnal awakenings; bedtime problems; parent-child attachment; Storybook application; caregiver-mediated intervention; Brief Infant Sleep Questionnaire; BISQ; BEARS Sleep Screening Tool; Attachment Q-Set; AQS
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Health Behavior; Sleep Initiation and Maintenance Disorders; Sleep Hygiene
• Other Study ID Numbers: 12-EO-CEISH-HLV-2023; PICODS21-04 (Other Grant/Funding Number: Universidad Católica de Cuenca); 12-EOCEISH-HLV-2023 (Other Identifier: Comité de Ética en Investigación en Seres Humanos del Hospital Luis Vernaza)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data and supporting information may be requested beginning 6 months after publication of the main study results and will remain available for 5 years.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No