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

1 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny 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.
Behawioralne: 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.
Inne nazwy:
  • Cognitive Behavioral Therapy-Based Psychoeducation
  • CBT Sleep Psychoeducation
Eksperymentalny: 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.
Behawioralne: 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.
Inne nazwy:
  • Storybook App
  • Storybook mHealth Intervention
  • Multimodal mHealth Sleep Intervention

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Nocturnal Sleep Duration
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Daytime Sleep Duration
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Universidad Católica de Cuenca

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

12 marca 2024

Zakończenie podstawowe (Rzeczywisty)

20 czerwca 2024

Ukończenie studiów (Rzeczywisty)

20 czerwca 2024

Daty rejestracji na studia

Pierwszy przesłany

19 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

25 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 12-EO-CEISH-HLV-2023
  • PICODS21-04 (Inny numer grantu/finansowania: Universidad Católica de Cuenca)
  • 12-EOCEISH-HLV-2023 (Inny identyfikator: Comité de Ética en Investigación en Seres Humanos del Hospital Luis Vernaza)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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