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

2026년 7월 1일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
행동: 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.
다른 이름들:
  • Cognitive Behavioral Therapy-Based Psychoeducation
  • CBT Sleep Psychoeducation
실험적: 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.
행동: 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.
다른 이름들:
  • Storybook App
  • Storybook mHealth Intervention
  • Multimodal mHealth Sleep Intervention

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Nocturnal Sleep Duration
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Daytime Sleep Duration
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Universidad Católica de Cuenca

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 3월 12일

기본 완료 (실제)

2024년 6월 20일

연구 완료 (실제)

2024년 6월 20일

연구 등록 날짜

최초 제출

2026년 6월 19일

QC 기준을 충족하는 최초 제출

2026년 6월 19일

처음 게시됨 (실제)

2026년 6월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 1일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 12-EO-CEISH-HLV-2023
  • PICODS21-04 (기타 보조금/기금 번호: Universidad Católica de Cuenca)
  • 12-EOCEISH-HLV-2023 (기타 식별자: Comité de Ética en Investigación en Seres Humanos del Hospital Luis Vernaza)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다