Protocol summary

Study aim
To investigate the effectiveness of an educational intervention based on Dialectical Behavior Therapy in reducing alexithymia and anxiety in adolescents with Autism Spectrum Disorder (ASD).
Design
This is a quasi-experimental study with a pretest–posttest design and a control group, with participants randomly allocated to intervention and control groups.
Settings and conduct
The study will be conducted in exceptional schools in Borazjan. After participant selection and random allocation into two groups, a pretest will be conducted. The intervention group will receive a structured group-based educational intervention based on Dialectical Behavior Therapy, while the control group will continue its usual school program. A posttest will be conducted for both groups after completion of the intervention.
Participants/Inclusion and exclusion criteria
Adolescents with Autism Spectrum Disorder (ASD) attending exceptional schools in Borazjan Official diagnosis of Autism Spectrum Disorder, being within the adolescent age range, ability to participate in group sessions, parental consent, and no concurrent similar interventions. Lack of an official ASD diagnosis, being outside the adolescent age range, inability to participate in group sessions, lack of parental consent, or concurrent receipt of similar interventions.
Intervention groups
One intervention group of 26 adolescents with ASD receiving an educational intervention based on Dialectical Behavior Therapy (DBT), and one control group of 26 participants receiving no intervention and continuing their usual school program.
Main outcome variables
Alexithymia Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260816070681N1
Registration date: 2026-09-25, 1405/07/03
Registration timing: registered_while_recruiting

Last update: 2026-09-25, 1405/07/03
Update count: 0
Registration date
2026-09-25, 1405/07/03
Registrant information
Name
Naznin Joomhoori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3424 4860
Email address
nazninjoomhoori@mail.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-09-13, 1405/06/22
Expected recruitment end date
2026-10-06, 1405/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of an Educational Intervention Based on Dialectical Behavior Therapy on Alexithymia and Anxiety in Adolescents with Autism
Public title
Investigating the Effect of Dialectical Behavior Therapy Training on Alexithymia and Anxiety in Adolescents with Autism
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having an official diagnosis of Autism Spectrum Disorder (ASD) based on educational and diagnostic records. Being within the adolescent age range Being enrolled in exceptional schools in Borazjan. Having the ability to participate in group intervention sessions. Providing informed parental consent for participation in the study. Not receiving other similar interventions concurrently.
Exclusion criteria:
Lack of an official diagnosis of Autism Spectrum Disorder Being outside the adolescent age range Inability to participate in group sessions Lack of parental consent, Concurrent receipt of similar interventions.
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
After identifying and selecting eligible participants, they will be randomly allocated in equal numbers to two groups: an intervention group and a control group (26 participants in each group). After identifying and selecting eligible participants and obtaining informed consent from their parents, each participant will be assigned a code. The participants will then be allocated equally to the intervention and control groups using simple randomization and a random number table, with 26 participants assigned to the intervention group and 26 participants assigned to the control group. Following random allocation, the intervention group will receive the educational intervention based on Dialectical Behavior Therapy, while the control group will continue to receive the routine school program during the intervention period
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
Research Ethics Committee of Islamic Azad University, Marvdasht Branch
Street address
Marvdasht–Persepolis Road, Islamic Azad University, Marvdasht Branch
City
Marvdasht
Province
Fars
Postal code
7371113119
Approval date
2026-06-08, 1405/03/18
Ethics committee reference number
IR.IAU.M.REC.1405.209

Health conditions studied

1

Description of health condition studied
Autism Spectrum Disorder (ASD)
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder

Primary outcomes

1

Description
Alexithymia refers to difficulty in identifying, describing, and distinguishing one's own and others' emotions. In this study, alexithymia will be assessed using the Toronto Alexithymia Scale (TAS-20), with higher scores indicating greater alexithymia. Anxiety refers to the level of anxiety symptoms in adolescents. In this study, anxiety will be assessed using a standardized anxiety questionnaire appropriate for the adolescent age group.
Timepoint
Pre-test: Before the beginning of the educational interventionPost-test: Immediately after completion of the educational intervention
Method of measurement
Alexithymia will be measured using the Toronto Alexithymia Scale (TAS-20), consisting of 20 items rated on a 5-point Likert scale. Higher scores indicate greater alexithymia. Anxiety will be measured using an age-appropriate anxiety questionnaire assessing cognitive, emotional, and physical anxiety symptoms. Higher scores indicate greater anxiety.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A group-based educational intervention based on Dialectical Behavior Therapy (DBT) will be provided in 8 sessions, each lasting 90 minutes, for adolescents with autism. The intervention includes training in distress tolerance, mindfulness, emotion regulation, and interpersonal effectiveness skills. The aim is to improve alexithymia and reduce anxiety.
Category
Behavior

2

Description
Control group: The control group will not receive any educational intervention during the intervention period and will continue the usual school program.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Exceptional Schools of Borazjan
Full name of responsible person
Ahmad Arabzadeh
Street address
Aftab Aramesh Specialized Counseling and Psychological Services Clinic, next to Nobat Clinic, Chamran Street, Borazjan
City
Borazjan
Province
Boushehr
Postal code
7565146915
Phone
+98 917 333 3557
Email
Arabzadehdr@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ruhollah Arshadi
Street address
Bushehr – Municipality Square – Beginning of Shahid Raisali Delvari Boulevard – Velayat Building (Islamic Azad University of Bushehr Province and Bushehr Branch)
City
Bushehr
Province
Boushehr
Postal code
7515895496
Phone
+98 77 3335 0172
Email
info@bushehr.iau.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
Ruhollah Arshadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Velayat Building (Islamic Azad University of Bushehr Province and Bushehr Branch) – Beginning of Shahid Raisali Delvari Boulevard – Municipality Square
City
Bushehr
Province
Boushehr
Postal code
7561163877
Phone
+98 77 3424 4860
Email
nazninjoomhoori@mail.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ruhollah Arshadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Velayat Building (Islamic Azad University of Bushehr Province and Bushehr Branch) – Beginning of Shahid Raisali Delvari Boulevard – Municipality Square
City
Bushehr
Province
Boushehr
Postal code
7561163877
Phone
+98 77 3424 4860
Email
nazninjoomhoori@mail.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ruhollah Arshadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Velayat Building (Islamic Azad University of Bushehr Province and Bushehr Branch) – Beginning of Shahid Raisali Delvari Boulevard – Municipality Square
City
Bushehr
Province
Boushehr
Postal code
7561163877
Phone
0098774244860
Email
nazninjoomhoori@mail.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Individual participant data will not be shared because there is no plan to make individual-level data publicly available. Participant confidentiality and privacy will be maintained, and study results will be reported only in aggregate form.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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