Storybook App vs Cognitive Behavioral Therapy for Child Sleep and Attachment

NCT07668609 | Completed

• 3 other identifiers: 12-EO-CEISH-HLV-2023PICODS21-0412-EOCEISH-HLV-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Sleep Problems; Sleep Hygiene; Parent-Child Attachment

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

Outcome Measures

Primary Outcomes (4)

• 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, 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.

  Baseline and immediately after the 1-month intervention period

Secondary Outcomes (3)

• Change From Baseline in Daytime Sleep Duration

  Baseline and immediately after the 1-month intervention period

• Change From Baseline in Nocturnal Wakefulness

  Baseline and immediately after the 1-month intervention period

• Change From Baseline in BEARS Sleep Screening Domains

  Baseline and immediately after the 1-month intervention period

Study Arms (2)

CBT-Based Psychoeducation

ACTIVE COMPARATOR

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

Storybook Mobile Application

EXPERIMENTAL

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

Interventions

CBT-Based Psychoeducational Intervention BEHAVIORAL

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.

Also known as: Cognitive Behavioral Therapy-Based Psychoeducation, CBT Sleep Psychoeducation

CBT-Based Psychoeducation

Storybook Mobile Application Intervention BEHAVIORAL

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.

Also known as: Storybook App, Storybook mHealth Intervention, Multimodal mHealth Sleep Intervention

Storybook Mobile Application

Eligibility Criteria

• Age: 12 Months - 84 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica de Cuenca: lead

Study Sites (1)

Universidad Católica de Cuenca

Cuenca, Azuay, 010101, Ecuador

Location

MeSH Terms

Conditions

Sleep Hygiene; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Juan P Viñanzaca López, MSc

  Universidad Católica de Cuenca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: March 12, 2024
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• 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.

Locations

EC (1)