Bibliotherapy Combined With Games to Reduce Fear of the Dark in Young Children

July 14, 2025 updated by: Mireia Orgilés Amorós, Universidad Miguel Hernandez de Elche

Efficacy of Bibliotherapy Combined With Games to Reduce Fear of the Dark in Young Children: Results From a Clinical Trial

Intense fear of the dark is a common issue among children, which can interfere with their daily functioning at family, social, and academic levels. This study aims to analyse the effectiveness of a psychotherapeutic intervention based on bibliotherapy combined with play to overcome the fear of the dark in children between 4 and 8 years old. A total of 38 children participated, who were assigned to the experimental and control conditions on the waiting list. The bibliotherapy intervention in the experimental condition involved reading a book and playing the games proposed in each chapter. The intervention was applied by parents at home with their children (during 4-5 weeks) and contained cognitive-behavioural techniques, such as gradual in vivo exposure, relaxation techniques, modelling and positive reinforcement, among others. It is expected that children's nighttime fears will decrease significantly and there will be significant improvements in nighttime behaviour.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Universidad Miguel Hernández

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between 4 and 8 years old
  • Obtaining a score of 32 or higher on the Parent Version of the Nighttime Fears Scale (NFS-P; Orgilés et al., 2024)

Exclusion Criteria:

  • Not being within the established age range
  • Scoring less than 31on the Parent Version of the Nighttime Fears Scale (NFS-P; Orgilés et al., 2024)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group receiving bibliotherapeutic intervention
Bibliotherapy combined with games to overcome fear of the dark
Behavioral: Bibliotherapy combined with games to overcome fear of the dark
Bibliotherapy combined with games, applied by parents at home. Treatment based on cognitive-behavioural techniques. Duration: 4-5 weeks. Experimental group recived this bibliotherapeutic intervention.
No Intervention: Waiting list control group (receiving intervention at the end of treatment with experimental group)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nighttime fears
Time Frame: Pre- and post-intervention assessment (treatment lasts 4-5 weeks). There will also be a follow-up assessment 12 months after the end of the intervention.
Parent Version of the Nighttime Fears Scale (NFS-P): The NFS-P assesses school-age children's level of fear at night, as reported by their parents. It contains four subscales: fear of nighttime features and distressing experiences (stimuli associated with darkness), fear of loss or separation from family (loss or non-presence of attachment figures and other family members), fear of imaginary stimuli (non-factual stimuli that may be likely to cause fear) and fear of real stimuli. It consists of 21 items that ask about night-time situations that are likely to cause fear in children. These items have a 5-point response scale, ranging from 0 (Not at all) to 4 (Very much). The higher the score, the greater the intensity of night-time fears.
Pre- and post-intervention assessment (treatment lasts 4-5 weeks). There will also be a follow-up assessment 12 months after the end of the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nighttime functioning
Time Frame: From enrollment to the end of treatment at 4-5 weeks
On a daily basis, families completed a log on different behaviours of their children during the night. Variables included: number of minutes it takes to go to bed, number of minutes it takes to fall asleep, avoidance behaviours, need for company to fall asleep, presence of security light, number of night-time calls to parents' bed, number of night-time visits to parents' bed, whether they sleep in their bed all night and, finally, whether they made use of the book and/or games.
From enrollment to the end of treatment at 4-5 weeks
Nighttime functioning
Time Frame: Pre- and post-intervention assessment (treatment lasts 4-5 weeks). There will also be a follow-up assessment 12 months after the end of the intervention.
Nighttime Behaviors Questionnaire for Children - Parent-reported (NBQC-P): The NBQC-P assesses, through parents' responses, children's usual behaviours before going to sleep and during the night. It consists of three subscales: need for company, problems during the night and problems going to sleep. It contains 13 items, with a Likert-type response scale from 0 (Never or almost never) to 4 (Always or almost always). A higher score on each dimension implies a greater need for company to sleep, greater resistance before going to bed and greater interference with night-time awakenings.
Pre- and post-intervention assessment (treatment lasts 4-5 weeks). There will also be a follow-up assessment 12 months after the end of the intervention.
Adaptive nocturnal behaviours
Time Frame: Pre- and post-intervention assessment (treatment lasts 4-5 weeks). There will also be a follow-up assessment 12 months after the end of the intervention.
What I Can Do At Night - Parent Form (WICDAN-P): It assesses, through parents, children's ability to perform adaptive night-time behaviours during the last week. The scale consists of 11 items, with a 3-point response scale (0 = No; 1 = Yes, with difficulty or hesitation; 2 = Yes, with ease). The total score of the questionnaire is from 0 to 22. A higher score indicates adaptive night-time behaviour.
Pre- and post-intervention assessment (treatment lasts 4-5 weeks). There will also be a follow-up assessment 12 months after the end of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Miguel Hernandez de Elche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DPS.MOA.210423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to the small sample size and the sensitive nature of children's psychological data, with the primary aim of ensuring confidentiality and anonymity.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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