Protocol summary

Study aim
Investigating the effectiveness of internet based mindfulness training on parental stress,illness perception,coping styles, and quality of life in parents of children with autism.
Design
This is a quasi-experimental study with a pretest–posttest design and a control group; 40 participants will be randomly allocated to intervention and control groups (20 participants per group), and the study will be conducted without blinding.
Settings and conduct
The study population consists of all parents of children with Autism Spectrum Disorder in Semnan who are within one year of their child’s confirmed diagnosis by accredited centers.The data will be statistically analyzed using SPSS software (version 26).Descriptive statistics and inferential statistics, including multivariate analysis of covariance (MANCOVA) and univariate analysis of covariance(ANCOVA) on post-test scores while controlling for pre-test scores,will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1.Having a child with a confirmed and valid diagnosis of autism spectrum disorder.2.No more than 12 months having elapsed since the child's diagnosis.3.Residency in the city of Semnan.4.Ability to read and write in Persian.Exclusion criteria:1.Absence from more than two intervention sessions.2.Onset of an acute psychiatric disorder or severe illness in the parent or child.3.Occurrence of a family crisis affecting continuation of the study.4.Withdrawal from the research.
Intervention groups
Eight sessions of internet based mindfulness training The control group does not receive the intervention during the study period and is assessed after the study concludes.
Main outcome variables
Independent variable: Internet information literacy.Dependent variables: Parental stress.Dependent variables: Perceived illness.Dependent variables: Coping styles.Dependent variables: Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260812070633N1
Registration date: 2026-09-03, 1405/06/12
Registration timing: registered_while_recruiting

Last update: 2026-09-03, 1405/06/12
Update count: 0
Registration date
2026-09-03, 1405/06/12
Registrant information
Name
samaneh gholinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 7297
Email address
samanehgholinezhad@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-25, 1405/06/03
Expected recruitment end date
2027-02-19, 1405/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Internet-Based Mindfulness Training on Parental Stress, Perceived Illness, Coping Styles, and Quality of Life in Families with Newly Diagnosed Autism
Public title
The Effectiveness of Internet-Based Mindfulness Training on Parental Stress, Illness Perception, Coping Styles, and Quality of Life Among Parents of Children Newly Diagnosed with Autism Spectrum Disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child with Autism Spectrum Disorder (ASD) confirmed and registered by accredited centers. A maximum of 12 months (one year) has elapsed since the child's definitive diagnosis. The family's residence in the city of Semnan Ability to read and write in Persian to complete the questionnaires. Willingness and informed consent to participate in all intervention sessions and complete the pre-test and post-test stages. No prior experience participating in formal, internet-based mindfulness training courses.
Exclusion criteria:
Failure to actively participate in more than two sessions of the group intervention. A parent suffering from acute psychiatric disorders or instability requiring immediate hospitalization. Occurrence of a family crisis or a severe illness in a parent or child that prevents continued cooperation. Willingness to withdraw at any stage of the research Simultaneous initiation of another structured psychotherapy during the conduct of the study. Need to initiate or make a major change to the parent's psychiatric medication regimen during the intervention period.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Upon meeting eligibility criteria and obtaining informed consent, each participant is assigned a code. Participants will be randomly allocated to either the intervention or control group using a random number table via simple randomization. Individuals will be assigned to one of the two groups based on the sequence of random numbers.
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 Islamic Azad University, Semnan Branch
Street address
Km 5, Damghan Road, Islamic Azad University, Semnan Branch, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
۳۷۱۱۱-۳۵۱۳۱
Approval date
2026-07-27, 1405/05/05
Ethics committee reference number
IR.IAU.SEMNAN.REC.1405.064

Health conditions studied

1

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

Primary outcomes

1

Description
Parental stress: The level of stress experienced by the parent in relation to the parenting role and the circumstances arising from the child's autism spectrum disorder, measured using the Parenting Stress Questionnaire.
Timepoint
After the intervention ended
Method of measurement
Standard Parenting Stress Index (PSI) questionnaire; standard "Illness Perception Questionnaire – Parent Version" (IPQ-R); Coping with Stressful Situations questionnaire; standard World Health Organization Quality of Life (WHOQOL-BREF) questionnaire.

Secondary outcomes

1

Description
The level of parental stress in parents of children with autism spectrum disorder, measured using a standardized parental stress questionnaire before and after the intervention.
Timepoint
Before the intervention (pre-test) and immediately after completion of the 8-session intervention (post-test).
Method of measurement
Parental stress will be measured using the Parenting Stress Index (PSI). The questionnaire will be completed by the parents, and the total score will be considered as an indicator of the level of parental stress. The variable will be assessed at two time points: before the intervention (pre-test) and immediately after completion of the intervention (post-test).

Intervention groups

1

Description
Intervention group: Parents in the intervention group receive internet-based mindfulness training over the course of eight sessions. The session content includes mindfulness exercises, meditation, breath awareness, awareness of thoughts and emotions, and stress management.
Category
Behavior

2

Description
Control group: The control group receives no educational or therapeutic intervention during the study period and is placed on a waiting list. Research assessments are also conducted for this group at the scheduled times.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Semnan Autism Center
Full name of responsible person
Samaneh Gholinezhad
Street address
Unit 1, Fajr 6, Sane 28, Sanati Saz Modiran, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
۳۵۱۴۴۳۶۱۶۱
Phone
+98 990 345 9515
Email
samanehgholinezhd@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nader Rahbar
Street address
Km 5, Damghan Road, Islamic Azad University, Semnan Branch, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
۳۷۱۱۱-۳۵۱۳۱
Phone
+98 990 345 9515
Email
samanehgholinezhd@gmail.com
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
10
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
Samaneh gholinezhad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Saneh 28, Fajr 6, Modiran Industrial Complex
City
Semnan
Province
Semnan
Postal code
۳۵۱۴۴۳۶۱۶۱
Phone
023334524578
Email
samanehgholinezhd@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samaneh gholinezhad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Saneh 28, Fajr 6, Modiran Industrial Complex
City
Semnan
Province
Semnan
Postal code
۳۵۱۴۴۳۶۱۶۱
Phone
+98 23 3345 8245
Email
samanehgholinezhd@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samaneh gholinezhad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Saneh 28, Fajr 6, Modiran Industrial Complex
City
Semnan
Province
Semnan
Postal code
۳۵۱۴۴۳۶۱۶۱
Phone
+98 23 3345 7297
Email
samanehgholinezhd@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The research data include demographic information and results from questionnaires regarding parental stress, illness perception, coping styles, and quality of life. Participants' identifying information will not be disclosed to others.
When the data will become available and for how long
پس از پایان پژوهش و انتشار نتایج، در صورت درخواست و با رعایت محرمانگی اطلاعات
To whom data/document is available
University researchers
Under which criteria data/document could be used
The data may be used solely for research purposes, subject to the preservation of confidentiality and the removal of participants' identifying information.
From where data/document is obtainable
The study's principal investigator, via the contact information listed in the IRCT system.
What processes are involved for a request to access data/document
Upon receipt of a written request, the researcher will review the proposal—considering the research objective and ensuring the confidentiality of participant data—and, if approved, will provide de-identified data.
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