NCT07067320

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

June 11, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

Nighttime fearsBibliotherapyPsychological treatmentClinical trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    From enrollment to the end of treatment at 4-5 weeks

  • Nighttime functioning

    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

    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.

Study Arms (2)

Experimental group receiving bibliotherapeutic intervention

EXPERIMENTAL

Bibliotherapy combined with games to overcome fear of the dark

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

Interventions

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.

Experimental group receiving bibliotherapeutic intervention

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Miguel Hernández

Elche, Alicante, 03202, Spain

Location

MeSH Terms

Conditions

Nyctophobia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 11, 2025

First Posted

July 16, 2025

Study Start

April 24, 2023

Primary Completion

October 18, 2024

Study Completion

October 18, 2024

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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.

Locations