Protocol summary

Study aim
Determining the effectiveness of an educational-interventional program based on the Pender model to improve treatment compliance behavior in parents of children with autism spectrum disorder
Design
This experimental study has a control group, with randomized parallel groups, phase 1 on 94 parents, Excel software will be used for randomization.
Settings and conduct
In this way, after obtaining the necessary permits from the university officials, first a list of psychological treatment centers for patients with autism spectrum disorders in Hamedan city is prepared and then 2 centers are randomly selected and then the samples will be selected randomly among the parents of children who refer to these centers, test and control.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study also included residing in the city of Hamedan; willingness to participate in the study (completing a consent form, interviewing, completing a questionnaire), and having a file at the aforementioned center.The exclusion criteria for parents who are not able to respond and participate in the study or are under psychological counseling elsewhere, parents who have mental illnesses; Depression and the use of anti-stress and anxiety medications
Intervention groups
The educational intervention included attractive and innovative educational content for parents with autistic children, which included educational clips and animations with VideoScribe, posters, pamphlets, lectures and educational PowerPoints, and educational booklets.
Main outcome variables
Pender's model constracts includes perceived benefits, perceived barriers, behavioral emotions, interpersonal influencers, situational influencers, commitment to program implementation, treatment compliance behavior.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200914048719N5
Registration date: 2026-07-25, 1405/05/03
Registration timing: registered_while_recruiting

Last update: 2026-07-25, 1405/05/03
Update count: 0
Registration date
2026-07-25, 1405/05/03
Registrant information
Name
Hanieh Jormand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0090
Email address
jormand69h@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-16, 1405/02/26
Expected recruitment end date
2026-08-17, 1405/05/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of an intervention program based on the Pender model to promote treatment adherence behavior in parents of children with autism spectrum disorder
Public title
Investigating the effectiveness of an intervention program based on the Pender model to promote treatment adherence behavior in parents of children with autism spectrum disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria for the study also included residing in the city of Hamadan; willingness to participate in the study (completing a consent form, interviewing, completing a questionnaire), and having a file at the aforementioned center.
Exclusion criteria:
Parents who are unable to respond and participate in the study or are undergoing psychological counseling elsewhere, parents who suffer from mental illnesses; depression and use anti-stress and anxiety medications
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
In this study , the random allocation of parents to intervention and control groups using random block method will be conducted to achieve this goal , four sheets of paper will be prepared - two cards called intervention and two cards called control .these sheets of paper are placed in a container .parents will be selected at one time without being replaced , and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2025-09-02, 1404/06/11
Ethics committee reference number
IR.UMSHA.REC.1400.887

Health conditions studied

1

Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.0
ICD-10 code description
Childhood autism

Primary outcomes

1

Description
Treatment Adherence Habit
Timepoint
Before the educational intervention and 3 months later
Method of measurement
Using the self - made questionnaire based on pender model assessment test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The educational intervention included engaging and innovative educational content designed for parents of children with autism, including educational clips and animations with VideoScribe, posters, pamphlets, lectures, educational PowerPoints, and educational booklets. This educational intervention was designed solely for the test group in 4 sessions of 20 minutes, 2 times a week.
Category
Behavior

2

Description
Control group: the educational content is also provided by pamphlets for physical activity - aerobic exercise
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Autism treatment and counseling centers in Hamadan
Full name of responsible person
Hanieh Jormand
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 2096
Email
jormand69h@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical 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
Hamedan University of Medical Sciences
Full name of responsible person
Hanieh Jormand
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 2096
Email
h.jourmand@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr.Hanieh Jormand
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 2096
Email
h.jourmand@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Hanieh Jormand
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 2096
Email
h.jourmand@umsha.ac.ir

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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Loading...