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.
Přehled studie
Postavení
Detailní popis
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 studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Azuay
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Cuenca, Azuay, Ekvádor, 010101
- Universidad Católica de Cuenca
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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.
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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.
Ostatní jména:
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Experimentální: 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.
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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Nocturnal Sleep Duration
Časové okno: Baseline and immediately after the 1-month intervention period
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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.
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Baseline and immediately after the 1-month intervention period
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Change From Baseline in Sleep Onset Latency
Časové okno: Baseline and immediately after the 1-month intervention period
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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.
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Baseline and immediately after the 1-month intervention period
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Change From Baseline in Number of Night Wakings
Časové okno: Baseline and immediately after the 1-month intervention period
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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.
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Baseline and immediately after the 1-month intervention period
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Change From Baseline in Parent-Child Attachment Score
Časové okno: Baseline and immediately after the 1-month intervention period
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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.
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Baseline and immediately after the 1-month intervention period
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Daytime Sleep Duration
Časové okno: Baseline and immediately after the 1-month intervention period
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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.
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Baseline and immediately after the 1-month intervention period
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Change From Baseline in Nocturnal Wakefulness
Časové okno: Baseline and immediately after the 1-month intervention period
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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.
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Baseline and immediately after the 1-month intervention period
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Change From Baseline in BEARS Sleep Screening Domains
Časové okno: Baseline and immediately after the 1-month intervention period
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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.
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Baseline and immediately after the 1-month intervention period
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Juan P Viñanzaca López, MSc, Universidad Católica de Cuenca
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
- randomizovaná kontrolovaná studie
- mobilní zdraví
- kognitivně behaviorální terapie
- mHealth
- CBT
- spánková hygiena
- kvalitu spánku
- mobilní aplikace
- psychoedukace
- Ekvádor
- kojenecká masáž
- vztah rodič-dítě
- raného dětství
- latence nástupu spánku
- množství spánku
- rutina před spaním
- 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
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 12-EO-CEISH-HLV-2023
- PICODS21-04 (Jiné číslo grantu/financování: Universidad Católica de Cuenca)
- 12-EOCEISH-HLV-2023 (Jiný identifikátor: Comité de Ética en Investigación en Seres Humanos del Hospital Luis Vernaza)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
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