Protocol summary

Study aim
The effect of storytelling training for parents on sleep disorders of children with autism referred to Tehran Autism Center in the intervention group, 2017-2018.
Design
Controlled clinical trial with parallel group, without blinding, with simple randomization, and a sample size of 45 patients for both intervention and control groups based on the formula.
Settings and conduct
The researcher is a story therapist . During the first session, the training program was presented with a PowerPoint file, telling the first short story; expressing the story theme and teaching storytelling definitions and types of sleep disorders with a simple language; followed by additional training including storytelling goals and similar experiences in performance, and strengthening listening skills including nonverbal behaviors such as visual focus, maintaining the distance of the speaker, taking turns in the reading group, and answering parent' questions.
Participants/Inclusion and exclusion criteria
Full consent to participate in the study, parents of children aged 7 to 12 years of both sexes; parents of children with other mental disorders, lack of full consent, taking medications that affect sleep
Intervention groups
In the intervention group, after communicating intimately with the parents in the first session, the researcher told a story and then engaged in a semi-structured discussion with the parents about the story. At the end of each session, parents were asked to retell the story to ensure they learned the story points, and this process continued throughout all therapy sessions. Parents in the control group received no training. After completing the storytelling intervention, the questionnaires were filled in again by interviewing the parents of both intervention and control groups.
Main outcome variables
sleep disorders

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190204042612N1
Registration date: 2020-02-08, 1398/11/19
Registration timing: retrospective

Last update: 2020-02-08, 1398/11/19
Update count: 0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Mehrvash Hoseinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3331 4979
Email address
mehrvash.h.p@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-19, 1397/10/29
Expected recruitment end date
2019-06-19, 1398/03/29
Actual recruitment start date
2019-01-19, 1397/10/29
Actual recruitment end date
2019-06-19, 1398/03/29
Trial completion date
2019-06-19, 1398/03/29
Scientific title
The effect of storytelling training for parents on sleep disorders of autistic children
Public title
The effect of stories on children's sleep disorders
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Participants must fully consent to participate in the study. Children of parents participating in the study must be both boys and girls. Studied children must have at least a parent.
Exclusion criteria:
Children with other known mental disorders Parents’ and children’s lack of consent Taking medications that affect sleep disorders
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participant groups consisted of a control and an intervention group. The intervention, teaching storytelling to parents, was performed in the intervention group, but the control group received no intervention

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Islamic Azad University, Tehran Medical Branch
Street address
Central Islamic Azad University Organization, Shohada Hesarak Boulevard, University Square, Tehran
City
Tehran
Province
Tehran
Postal code
1477892855
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IAU.TMU.REC.1397.233

Health conditions studied

1

Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder

2

Description of health condition studied
Sleep Disorders
ICD-10 code
G47
ICD-10 code description
Sleep disorders

Primary outcomes

1

Description
The percentage of children with Children's Sleep Habits Questionnaire score of above 45.
Timepoint
Sleep disorder score before the start of the study and six weeks after the intervention
Method of measurement
Children's Sleep Habits Questionnaire (CSHQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Teaching storytelling therapy to parents in this group was done in 5 one-hour sessions. Initial introductions were made and the storytelling therapy class schedules, expectations and parental involvement were explained. First appropriate books for children with autism were introduced, including pictorial books with repetitive rhythms and letters that have short texts with simple stories. In the next step, relying on sound training and alphabet training techniques, a selected story was read aloud by the researcher for the parents. After ensuring trained parents’ skills, sessions continued by their participation and practice. During each session, participants were provided with the information needed to complete the next session assignments. Five selected short stories from storybooks for children with autism were color printed on A4 sheets and provided to the parents, and a story was practiced at each session. The first story introduces the main character which is a cat and where it lives. The second story, aimed at understanding and establishment of communication, introduces a family. The third story introduces the family members. The story continues with verbal and non-verbal skills, any use of verbal language, like saying “thank you”, “I know”, “yes” and non-verbal skills like whispers, touches like hand shaking on social encounters and tapping shoulders. The fourth story, aiming at identifying environmental factors, introduces rain. The final story is about sleep and observing sleeping and resting patterns, gets the child ready to sleep. First Session: At first, the researcher introduced herself to the members of the group after welcoming them. She explained about the training program and its content using a PowerPoint file. Parents were told that it is important to learn new skills with the help the researcher during the course and to express any questions they may have during the training. After introduction of other members, the first short story was read by the researcher in order to break the ice and create an intimate atmosphere. Parents were discussed with about the content of the first story while expressing the content in simple language with the necessary equipment. The session concluded after completing complementary activities, having a break, and explaining home activities. Second Session: After teaching definitions of storytelling and different kinds of sleep disorders, parents were asked to perform the second short story based on their similar experiences and problems were resolved. It was recommended to perform the short story in a safe, pleasant and attractive environment; with a third person, easy and indirect language; with manipulation and control, flexibility and variability. Third Session: At this session, the goals of the storytelling and its types were first described, and then a role from the third short story was given to each of the group members. After knowing their dialogues, each person read their own parts as anticipated during the story telling by the researcher and the story was read as a group. Strengthening listening skills were performed including nonverbal behaviors such as visual focus, maintaining the distance of the speaker, taking turns in the reading group, and answering others' questions. Fourth Session: The fourth short story card was taught and then the story was simply presented by the researcher. Evaluation of children's responses to three stories was performed by the researcher through question and answer with parents. The parents described a set of problems they had when reading a story to find a solution, and all the ideas were written on the classroom board, then solution were suggested by brainstorming. Fifth Session: Parents were remarked about the steps of storytelling at home before sleeping by showing the short story cards and following its performance, and repeating the steps by the researcher, if necessary. The fifth story was performed by a researcher in a reading aloud manner. Parents found more courage in performing roles.
Category
Behavior

2

Description
The control group: Children whose parents were in the control group underwent routine treatments of the autism center.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Autism Children's Charity Foundation
Full name of responsible person
Nasser Zojaji
Street address
No. 76, Kalantari Ave., Qarani St., Ferdowsi Square.
City
Tehran
Province
Tehran
Postal code
1598833954
Phone
+98 21 8892 3232
Fax
+98 21 8890 2948
Email
info@autismcharity.ir
Web page address
https://www.autismcharity.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Danesh alley, Gholhak St., Shariati St.
City
Tehran
Province
Tehran
Postal code
193951495
Phone
+98 21 2200 6660
Email
Hashemian.f@iaups.ac.ir
Web page address
http://www.iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mohammed Saheb Zamani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
6th Floor, Sattari Highway, University Square, Shohada Hesarak Blvd, Azad University Central Building.
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4735 3201
Fax
Email
m_szamani@iautmu.ac.ir
Web page address
https://www.iau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Saheb Zamani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Sixth Floor, Azad University Central Building, Shohadaye Hesarak St., University Square, Sattari Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4735 3201
Email
m_szamani@iautmu.ac.ir
Web page address
https://www.iau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrvash Hoseinpour
Position
Master
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 30, Khordad alley, 17 Shahrivar St., Shohada Square
City
Tehran
Province
Tehran
Postal code
1714633495
Phone
+98 912 085 0248
Email
Mehrvash.h.p@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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