Determining the effect of family empowerment intervention on the intensity of suicidal thoughts and recurrence of suicidal attempts in adolescents.
Design
The clinical trial has a control group, is randomized on 80 patients, and the block method is used for randomization.
Settings and conduct
The research units are 80 family members of adolescents who attempted suicide and were hospitalized in the pediatric ward of Ibn Sina Hospital. They will be randomly assigned to two intervention and control groups. The intervention group will receive 5 45-minute sessions of empowerment in the field of suicide (severity and recurrence). Blinding will not be performed.
Participants/Inclusion and exclusion criteria
Adolescents inclusion criteria : At least one suicide attempt,Admission to Ibn Sina Hospital , Living with at least one family member permanently
Adolescents Exclusion criteria: Severe mental disability
Family inclusion criteria : No previous participation in empowerment and education courses
Family Exclusion criteria :behavioral disorders
Intervention groups
The intervention group consists of families of suicidal adolescents who will receive family empowerment interventions throughout the course. The control group consists of families of suicidal adolescents who will receive empowerment interventions at the end of the course.
Main outcome variables
Severity of suicidal ideation (score from the Beck Suicidal Ideation Questionnaire); Number of suicide attempt recurrences during the follow-up period; Time to first suicide attempt recurrence (in days or months); Rate of readmission to hospital or emergency room due to suicide attempt; Level of family cohesion, support, and functioning (score from the Family Empowerment Questionnaire).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260512069371N1
Registration date:2026-06-09, 1405/03/19
Registration timing:registered_while_recruiting
Last update:2026-06-09, 1405/03/19
Update count:0
Registration date
2026-06-09, 1405/03/19
Registrant information
Name
mohaddesh hasanzadehmoghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 992 372 4379
Email address
mohaddesehhasanzadeh92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2026-07-06, 1405/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intervention family empowerment on the severity of suicidal thoughts and recurrence of attempted suicide in acting teenagers
Public title
The effect of family empowerment on suicidal thoughts and recurrence
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents: 1-At least one suicide attempt
2-Admission to Ibn Sina Hospital
3-Living with at least one family member permanently
4-Residing in the city and not facing legal prosecution
5-Being literate
family: 1- Be literate
2- Have not participated in previous empowerment and training courses
3- Do not have any DSM-5 disorders
4- Do not have any life-threatening or disabling physical disorders
5- Be over 18 years old and under 65 years old
Exclusion criteria:
Adolescents: Severe mental disability
family: participating in empowerment and other training courses
Behavioral disturbance, evidence of prior psychosis
Participate in other empowerment and training courses
Severe mental disability that impairs the ability to understand informed consent
Age
From 13 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
"This study will use a block randomization method with variable block sizes (4 and 6). The randomization unit was the individual (each patient). Randomization will be stratified by gender (male/female) and disease severity (mild/moderate/severe). The randomization sequence will be determined using the website.sealedenvelope. For allocation concealment, opaque, sealed, and sequentially numbered envelopes will be used. The allocation sequence is hidden from the investigator. The envelopes will be opened by someone independent of the principal investigator. The quasi-randomization method was not used in this study."
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Kharazmi Complex, Faculty of Nursing
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2026-02-28, 1404/12/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1404.140
Health conditions studied
1
Description of health condition studied
suicide
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of suicidal ideation score based on the Beck Scale for Suicidal Ideation (BSSI), which has a minimum score of 0 and a maximum score of 38. A higher score indicates greater severity of suicidal ideation.
Timepoint
Both groups will receive the Beck Suicidality Scale (BSSI) questionnaire, demographic information questionnaire, and Family Empowerment Scale (FES) in the pre-test phase, and the Beck Suicidality Scale and Family Empowerment Scale in the post-test phase (one month after training).
Method of measurement
Beck Suicidal Thought Questionnaire and Family Empowerment Questionnaire
2
Description
Number of suicide attempts during the two-month follow-up period (number of times the adolescent attempts suicide again that requires hospitalization or emergency room visit).
Timepoint
After a two-month period of family empowerment, we will check for repeated suicide attempts by calling the family and reviewing the hospital's list.
Method of measurement
Using a phone call to family
Secondary outcomes
empty
Intervention groups
1
Description
After the research units of the intervention group were determined, the researcher made the necessary coordination with the respected supervisor to hold the date and time of the meetings and informed them on the Yes channel. And by creating a survey to check the presence of caregivers the night before, the date and time of the meetings were finalized. Family empowerment sessions were held every other day for two weeks, with 3 45-minute sessions each week in the classroom of the pediatric ward of Ibn Sina Teaching Hospital. During the empowerment sessions, exercises were included in some sessions that the research units were required to do, and the assignments were explained in person in the next session, and the caregivers were discussed about the assignment and its feedback.It should be noted that the content of the sessions was summarized in the Yes channel related to the group after the end of each session. Content of the sessions: Session 1: Coping with the phenomenon of suicide by caregivers, self-care b) What should I tell people? Session 2: Safety planning for suicidal concerns Session 3: Crisis prevention planning Session 4: Behavior modification Session 5: Review and summary of the material.
Category
Behavior
2
Description
Control group: Control group: After the research units were identified, training related to medication use and side effects was provided to the group. At the end of the period, empowerment training will be provided to the family.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Psychiatric Hospital
Full name of responsible person
Fatemeh Rajab Dizavandi
Street address
Mashhad University of Medical Sciences, Kharazmi Complex, Faculty of Nursing
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 938 027 1597
Email
mohaddesehhasanzadeh92@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Rajab Dizavandi
Street address
Mashhad University of Medical Sciences, Kharazmi Complex, Faculty of Nursing
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Rajab Dizavandi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Mashhad University of Medical Sciences, Kharazmi Complex, Faculty of Nursing
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6732
Email
rajabf2020@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Rajab Dizavandi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Mashhad University of Medical Sciences, Kharazmi Complex, Faculty of Nursing
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6732
Email
rajabf2020@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Rajab Dizavandi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Mashhad University of Medical Sciences, Kharazmi Complex, Faculty of Nursing
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6732
Email
rajabf2020@gmail.com
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
Yes - There is a plan to make this available
Title and more details about the data/document
Information and results will be provided anonymously.
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Submit a written request to the principal investigator along with a formal letter of introduction and research proposal approved by the ethics committee. Permitted analyses include secondary analyses related to valid scientific purposes. Non-commercial use and attribution of the original source are required. Data will be provided in an anonymized form only. Requests will be reviewed by the research team and, if approved, will be delivered after signing a data confidentiality agreement.
From where data/document is obtainable
They can first email the corresponding author, Dr. Fatemeh Rajab Dizavandi, or the student, Mohaddeseh Hassanzadeh.
Corresponding author email: rajabf2020@gmail.com
Student email: mohaddesehhasanzadeh92@gmail.com
What processes are involved for a request to access data/document
By sending an email to the responsible author or the relevant student, the file and data information will be received in less than a week, depending on the country's conditions.