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

1 juli 2026 uppdaterad av: Universidad Católica de Cuenca

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

60

Fas

  • Inte tillämpbar

Kontakter och platser

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Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Beteende: 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.
Andra namn:
  • Cognitive Behavioral Therapy-Based Psychoeducation
  • CBT Sleep Psychoeducation
Experimentell: 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.
Beteende: 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.
Andra namn:
  • Storybook App
  • Storybook mHealth Intervention
  • Multimodal mHealth Sleep Intervention

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Nocturnal Sleep Duration
Tidsram: 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.
Baseline and immediately after the 1-month intervention period
Change From Baseline in Sleep Onset Latency
Tidsram: 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.
Baseline and immediately after the 1-month intervention period
Change From Baseline in Number of Night Wakings
Tidsram: 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.
Baseline and immediately after the 1-month intervention period
Change From Baseline in Parent-Child Attachment Score
Tidsram: 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.
Baseline and immediately after the 1-month intervention period

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Daytime Sleep Duration
Tidsram: 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.
Baseline and immediately after the 1-month intervention period
Change From Baseline in Nocturnal Wakefulness
Tidsram: 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.
Baseline and immediately after the 1-month intervention period
Change From Baseline in BEARS Sleep Screening Domains
Tidsram: 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.
Baseline and immediately after the 1-month intervention period

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Universidad Católica de Cuenca

Utredare

  • Huvudutredare: Juan P Viñanzaca López, MSc, Universidad Católica de Cuenca

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 mars 2024

Primärt slutförande (Faktisk)

20 juni 2024

Avslutad studie (Faktisk)

20 juni 2024

Studieregistreringsdatum

Först inskickad

19 juni 2026

Först inskickad som uppfyllde QC-kriterierna

19 juni 2026

Första postat (Faktisk)

25 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 12-EO-CEISH-HLV-2023
  • PICODS21-04 (Annat bidrag/finansieringsnummer: Universidad Católica de Cuenca)
  • 12-EOCEISH-HLV-2023 (Annan identifierare: Comité de Ética en Investigación en Seres Humanos del Hospital Luis Vernaza)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

Data and supporting information may be requested beginning 6 months after publication of the main study results and will remain available for 5 years.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF

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Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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Nej

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