Pediatric Sleep ProblemsSTORYBOOK-RCTNCT07668609
Storybook App vs Cognitive Behavioral Therapy for Child Sleep and Attachment
A study testing CBT-Based Psychoeducational Intervention and Storybook Mobile Application Intervention in people with Pediatric Sleep Problems and Sleep Hygiene, run by Universidad Católica de Cuenca at 1 site in Ecuador.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 84 monthsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Sleep Problems, Sleep Hygiene, Parent-Child Attachment
- What is being tested?
- CBT-Based Psychoeducational Intervention and Storybook Mobile Application Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEcuador
- Study dates
- 12 Mar 2024to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 84 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- CBT-Based Psychoeducational Intervention, Storybook Mobile Application Intervention
- Keywords
- pediatric sleep, child sleep, sleep quality, sleep quantity, sleep hygiene, sleep onset latency, night wakings, nocturnal awakenings, bedtime problems, parent-child attachment, parent-child relationship, early childhood, mobile health, mHealth, mobile application, Storybook application, cognitive behavioral therapy, CBT, psychoeducation, caregiver-mediated intervention
- Medical subject headings
- Sleep Hygiene, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-Based Psychoeducational InterventionBehavioural
Also called Cognitive Behavioral Therapy-Based Psychoeducation, CBT Sleep Psychoeducation
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.
Storybook Mobile Application InterventionBehavioural
Also called Storybook App, Storybook mHealth Intervention, Multimodal mHealth Sleep 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.
| Study group | Role | What they receive |
|---|---|---|
| CBT-Based Psychoeducation | Active comparator | 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. Receives: Behavioral: CBT-Based Psychoeducational Intervention |
| Storybook Mobile Application | Experimental | 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. Receives: Behavioral: Storybook Mobile Application Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Nocturnal Sleep Duration
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.
Measured: Baseline and immediately after the 1-month intervention period
Change From Baseline in Sleep Onset Latency
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.
Measured: Baseline and immediately after the 1-month intervention period
Change From Baseline in Number of Night Wakings
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.
Measured: Baseline and immediately after the 1-month intervention period
Change From Baseline in Parent-Child Attachment Score
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.
Measured: Baseline and immediately after the 1-month intervention period
Secondary outcomes (3)
Change From Baseline in Daytime Sleep Duration
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.
Measured: Baseline and immediately after the 1-month intervention period
Change From Baseline in Nocturnal Wakefulness
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.
Measured: Baseline and immediately after the 1-month intervention period
Change From Baseline in BEARS Sleep Screening Domains
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.
Measured: Baseline and immediately after the 1-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start12 Mar 2024
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Sleep ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group randomized controlled trial. Participants were assigned to either a cognitive behavioral therapy-based psychoeducational intervention or a multimodal mHealth intervention delivered through the Storybook mobile application. Outcomes were assessed at baseline and after the 1-month intervention period.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Cuenca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan P Viñanzaca López, MSc, Principal investigator, Universidad Católica de Cuenca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668609
- Sponsor's protocol ID
- 12-EO-CEISH-HLV-2023
- Other IDs
- PICODS21-04, 12-EOCEISH-HLV-2023
- Acronym
- STORYBOOK-RCT
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of a Multimodal mHealth Intervention Versus Cognitive Behavioral Therapy for Pediatric Sleep and Parent-Child Attachment: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07668609
- Acronym / sponsor ID
- STORYBOOK-RCT / 12-EO-CEISH-HLV-2023
- Keywords
- pediatric sleep, child sleep, sleep quality, sleep quantity, sleep hygiene, sleep onset latency, night wakings, nocturnal awakenings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Católica de CuencaUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled trial. Participants were assigned to either a cognitive behavioral therapy-based psychoeducational intervention or a multimodal mHealth intervention delivered through the Storybook mobile application. Outcomes were assessed at baseline and after the 1-month intervention period.
| Arm | Type | Receives |
|---|---|---|
| CBT-Based Psychoeducation | Active comparator | Behavioral: CBT-Based Psychoeducational InterventionChild-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. |
| Storybook Mobile Application | Experimental | Behavioral: Storybook Mobile Application InterventionChild-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. |
Who may qualify
- Ages
- 12 to 84 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-Based Psychoeducational InterventionAlso: Cognitive Behavioral Therapy-Based Psychoeducation, CBT Sleep PsychoeducationCaregivers 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. | Behavioural | CBT-Based Psychoeducation |
| Storybook Mobile Application InterventionAlso: Storybook App, Storybook mHealth Intervention, Multimodal mHealth Sleep InterventionCaregivers 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. | Behavioural | Storybook Mobile Application |
Primary outcome
Change From Baseline in Nocturnal Sleep Duration
Time frame: 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.
Change From Baseline in Sleep Onset Latency
Time frame: 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.
Change From Baseline in Number of Night Wakings
Time frame: 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.
Change From Baseline in Parent-Child Attachment Score
Time frame: 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.
3 secondary outcomes
Change From Baseline in Daytime Sleep Duration
Time frame: Baseline and immediately after the 1-month intervention period
Change From Baseline in Nocturnal Wakefulness
Time frame: Baseline and immediately after the 1-month intervention period
Change From Baseline in BEARS Sleep Screening Domains
Time frame: Baseline and immediately after the 1-month intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan P Viñanzaca López, MSc principal investigator
Universidad Católica de Cuenca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-Based Psychoeducational Intervention and Storybook Mobile Application Intervention in people with Pediatric Sleep Problems and Sleep Hygiene, run by Universidad Católica de Cuenca at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Nocturnal Sleep Duration (time frame: Baseline and immediately after the 1-month intervention period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.