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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Azuay
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Cuenca、Azuay、エクアドル、010101
- Universidad Católica de Cuenca
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
他の名前：
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Nocturnal Sleep Duration
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline and immediately after the 1-month intervention period
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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.
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Baseline and immediately after the 1-month intervention period
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Daytime Sleep Duration
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Juan P Viñanzaca López, MSc、Universidad Católica de Cuenca
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
- ランダム化比較試験
- モバイルヘルス
- 認知行動療法
- mHealth
- CBT
- 睡眠衛生
- 睡眠の質
- モバイルアプリ
- 心理教育
- エクアドル
- 幼児マッサージ
- 親子関係
- 幼児期
- 入眠潜時
- 睡眠量
- 就寝時のルーチン
- 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
その他の研究ID番号
- 12-EO-CEISH-HLV-2023
- PICODS21-04 (その他の助成金/資金番号：Universidad Católica de Cuenca)
- 12-EOCEISH-HLV-2023 (その他の識別子：Comité de Ética en Investigación en Seres Humanos del Hospital Luis Vernaza)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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