Protocol summary

Study aim
Determining the effectiveness of a brief exposure-based intervention on the intensity and frequency of nighttime fears in children aged 4 to 8 years. Determining the effectiveness of a brief exposure-based intervention on the self-efficacy of 4 to 8-year-old children in dealing with nighttime fears.
Design
A clinical trial with a single-case experimental design with asynchronous multiple baselines
Settings and conduct
This intervention is implemented by parents at home.
Participants/Inclusion and exclusion criteria
The child’s age at the beginning of the treatment should be 4 to 8 years. Fear, anxiety, and avoidance should be constant and repeated and at least 6 months have passed since the child's fears started. According to the parents, fear and anxiety harm the performance of the child and the family. The child should avoid sleeping alone due to nighttime fears. The child and parents should have a complete command of the Persian language.; The child is currently receiving medication or psychotherapy for nighttime fears or other internalizing problems. The child has major health, neuro-developmental, and psychological problems that need treatment. Parents are illiterate or unable to read.
Intervention groups
The intervention is implemented by parents during 8 weeks. So parents should read a part of the story of the book to the child every night or play the book games with the child. During this period, once a week, parents share their problems with the researcher in a phone call. The intervention is provided by the book "Uncle Lightfoot: Flip that Switch". In 21 chapters, this book teaches 4 to 8-year-old children bedtime skills and reduces nighttime fears by presenting stories and teaching games.
Main outcome variables
The score of nighttime fears in the interview form with the child and the score of the child's Sleep Habits questionnaire; Self-efficacy in dealing with nighttime fears

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240129060841N1
Registration date: 2024-02-19, 1402/11/30
Registration timing: prospective

Last update: 2024-02-19, 1402/11/30
Update count: 0
Registration date
2024-02-19, 1402/11/30
Registrant information
Name
Zahra Nourian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 4300
Email address
zah.nourian@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-18, 1403/01/30
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Brief Exposure-Based Intervention on Reducing Nighttime Fears in 4-8 Years Children
Public title
The Effectiveness of Brief Exposure-Based Intervention on Reducing Nighttime Fears in 4-8 Years Children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The child's at the beginning of the treatment should be 4 to 8 years Fear, anxiety, and avoidance should be constant and repeated and at least 6 months have passed since the child's fears started According to the parents, fear and anxiety harm the performance of the child and the family The child should avoid sleeping alone due to nighttime fears The child and parents should have a complete command of the Persian language
Exclusion criteria:
The child is currently receiving medication or psychotherapy for nighttime fears or other internalizing problems The child has major health, neuro-developmental, and psychological problems that need treatment Parents are illiterate or unable to read
Age
From 4 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 6
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research of University of Social Welfare and Rehabilitation sciences
Street address
No. 14, Motammedi Alley, Dollat Ave., Pasdaran Crossroad
City
Tehran
Province
Tehran
Postal code
1945874154
Approval date
2024-01-24, 1402/11/04
Ethics committee reference number
IR.USWR.REC.1402.223

Health conditions studied

1

Description of health condition studied
nighttime fears
ICD-10 code
F93.1
ICD-10 code description
Phobic anxiety disorder of childhood

Primary outcomes

1

Description
The score of nighttime fears in the interview form with the child and the score of the child's Sleep Habits questionnaire.
Timepoint
Before starting the intervention, measurement of nighttime fears will be done every 3 days. During the intervention, the interview form with the child will be administered every three days and the Sleep Habits questionnaire will be administered every seven days.
Method of measurement
Child interview form and Child Sleep Habits Questionnaire

2

Description
Self-efficacy in dealing with nighttime fears
Timepoint
It will be evaluated every 3 days before starting the intervention and every 7 days during the implementation of the intervention.
Method of measurement
What My Child Can Do at Night in the Dark (Coffman, 1987)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After the initial assessment, a training session will be held for parents. During this meeting, explanations about the intervention process are presented and the required forms and materials are provided to the parents. Also, in this session, the translated version of the book, which includes stories and instructions for playing each of the games, will be presented to the parents. These guidelines help ensure that all subjects play the games in similar ways. The intervention is implemented by parents during 8 weeks. So parents (father or mother) should read a part of the story of the book to the child every night or play one or more of the book games with the child. It is also recommended that parents spend at least 1.5 hours reading books or playing games every week. After the end of 8 weeks, parents must have finished the book at least 2 times. During this period, once a week, parents share their problems with the researcher in a phone call for 10-20 minutes. The intervention is provided by the book "Uncle Lightfoot: Flip that Switch". In 21 chapters, this book teaches 4 to 8-year-old children bedtime skills and reduces nighttime fears by presenting stories and teaching various games. At the end, explanations are provided for parents about how to play the book and its games. 5 psychological techniques are used in this book: 1) Modeling: in this method, learning skills occur through observing the activities of the child whose story is narrated. 2) Gradual exposure: the child is first exposed to scary stimuli in the book and then Gradually, this encounter occurs in reality. 3) Desensitization: Using this technique, the child learns to associate positive and pleasant activities and images with darkness. 4) cognitive behavioral techniques: these techniques lead to changing the child's way of thinking when faced with scary situations and stimuli. Also, the child learns more about darkness. 5) Reinforcement: By using a reward (for example, a courage necklace), the child's appropriate behaviors are strengthened. The story of the book is about a boy with nighttime fears. Each chapter of the book is a step towards reducing these fears, and the child in the story plays games with his family members. In each chapter, the client who uses this book, after facing their fear in the story, plays the game related to that chapter with the family. Stories should be read to the child before bedtime. It is also recommended that games that require more movement be played 30 minutes to 1 hour before children's bedtime so as not to interfere with their sleep process. But other games can be played when the child is ready to sleep. Before playing each chapter of the book, parents should read the practical guide on how to play the game related to that chapter.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Jarfandish preschool and elementary school
Full name of responsible person
Mohammad Nourian
Street address
No. 54, Eslami Ave., Golestan 4 Alley, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1945874154
Phone
+98 21 2277 8023
Email
nourian2001@gmail.com
Web page address
http://jarfandish-school.com/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr Hamidreza Khankeh
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
pr@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Nourian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 14, Moatamedi Alley, Dollat Ave., Pasdaran Crossroad
City
Tehran
Province
Tehran
Postal code
1945874154
Phone
+98 21 2258 4300
Fax
Email
zah.nourian@uswr.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Nourian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 14, Moatamedi Alley, Dollat Ave., Pasdaran Crossroad
City
Tehran
Province
Tehran
Postal code
1945874154
Phone
+98 21 2258 4300
Fax
Email
zah.nourian@uswr.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Nourian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 14, Moatamedi Alley, Dollat Ave., Pasdaran Crossroad
City
Tehran
Province
Tehran
Postal code
1945874154
Phone
+98 21 2258 4300
Fax
Email
zah.nourian@uswr.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
People working in scientific and academic institutions and industry
Under which criteria data/document could be used
-
From where data/document is obtainable
Contact the researcher via email. (Zahra Nourian, email address: znourian2000@gmail.com)
What processes are involved for a request to access data/document
After checking the industrial or academic affiliation of the applicant, the request will be answered.
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