BibliotherapyNCT07067320
Bibliotherapy Combined With Games to Reduce Fear of the Dark in Young Children
A study testing Bibliotherapy combined with games to overcome fear of the dark in people with Bibliotherapy and Fear of the Dark, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Bibliotherapy, Fear of the Dark, Nighttime Fears
- What is being tested?
- Bibliotherapy combined with games to overcome fear of the dark
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSpain
- Study dates
- 24 Apr 2023to 18 Oct 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bibliotherapy, Fear of the Dark, Nighttime Fears
- Being tested
- Bibliotherapy combined with games to overcome fear of the dark
- Keywords
- Nighttime fears, Bibliotherapy, Psychological treatment, Clinical trial
- Medical subject headings
- Nyctophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bibliotherapy combined with games to overcome fear of the darkBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group receiving bibliotherapeutic intervention | Experimental | Bibliotherapy combined with games to overcome fear of the dark Receives: Behavioral: Bibliotherapy combined with games to overcome fear of the dark |
| Waiting list control group (receiving intervention at the end of treatment with experimental group) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nighttime fears
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.
Measured: 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 outcomes (3)
Nighttime functioning
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.
Measured: From enrollment to the end of treatment at 4-5 weeks
Nighttime functioning
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start24 Apr 2023
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BibliotherapyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireia Orgilés Amorós, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067320
- Sponsor's protocol ID
- DPS.MOA.210423
- Status last verified
- Jul 2025
- First submitted
- 11 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Orgiles M, Belzunegui-Pastor A, Amoros-Reche V, Espada JP. Efficacy of bibliotherapy combined with games to reduce fear of the dark in young children: results from a clinical trial. Eur J Pediatr. 2026 Apr 20;185(5):282. doi: 10.1007/s00431-026-06918-2.
PubMed 42008152
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bibliotherapy Combined With Games to Reduce Fear of the Dark in Young Children: Results From a Clinical Trial
- ClinicalTrials.gov ID
- NCT07067320
- Acronym / sponsor ID
- DPS.MOA.210423
- Conditions
- Bibliotherapy, Fear of the Dark, Nighttime Fears
- Keywords
- Nighttime fears, Bibliotherapy, Psychological treatment, Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 16 Jul 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group receiving bibliotherapeutic intervention | Experimental | Behavioral: Bibliotherapy combined with games to overcome fear of the darkBibliotherapy combined with games to overcome fear of the dark |
| Waiting list control group (receiving intervention at the end of treatment with experimental group) | No intervention | – |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| Bibliotherapy combined with games to overcome fear of the darkBibliotherapy combined with games, applied by parents at home. Treatment based on cognitive-behavioural techniques. Duration: 4-5 weeks. Experimental group recived this bibliotherapeutic intervention. | Behavioural | Experimental group receiving bibliotherapeutic intervention |
Primary outcome
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.
3 secondary outcomes
Nighttime functioning
Time frame: 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.
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.
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 16 Jul 2025.
- Derived from this study: PubMed 42008152Orgiles M, Belzunegui-Pastor A, Amoros-Reche V, Espada JP. Efficacy of bibliotherapy combined with games to reduce fear of the dark in young children: results from a clinical trial. Eur J Pediatr. 2026 Apr 20;185(5):282. doi: 10.1007/s00431-026-06918-2.
- Individual participant dataSharing planned: No. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bibliotherapy combined with games to overcome fear of the dark in people with Bibliotherapy and Fear of the Dark, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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 2 inclusion and 2 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 16 Jul 2025. 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 Spain. 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?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07067320, which also lists 1 linked publication.
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 16 Jul 2025.