NCT06290115

Brief Summary

The starting point of this project is to study young people and adolescents, aiming to explore the correlation between non-suicidal behavior of young people and adolescents and the negative emotional expression of their parents and family communication. The purpose of this project is to investigate the non-suicidal self-injury behavior of teenagers aged 15-25 years by issuing questionnaires (sample size: 327 people). In order to find out whether there is any connection between family communication and non-suicidal self-injury behavior of young people and adolescents.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

February 26, 2024

Last Update Submit

March 12, 2024

Conditions

Keywords

Adolescents and Young AdultsNon-suicidal self-injuryParental emotional expressivityFamily communication patterns

Outcome Measures

Primary Outcomes (3)

  • Non-suicidal self-injury behavior of young people and adolescents

    There are 28 items in the Ottawa Self-injury Inventory, which are used to evaluate the frequency of NSSI and suicide in the last 1, 6 and 12 months, the age of first onset, the source and concealment of self-injury ideas, and the feeling of self-injury impulse.

    Baseline

  • Expression of negative emotions of parents

    There are 40 items in the Parental Emotional Expression Questionnaire, which is used to measure parents' negative emotions. The scale adopts system, and the higher the dimension score, the greater the possibility of negative emotions.

    Baseline

  • Parent-Adolescent communication scale

    There are 40 items in the parent-Adolescent communication scale, which is used to measure parent-child communication. The scale adopts Likert 5-point system, and the higher the score, the better the parent-child communication.

    Baseline

Secondary Outcomes (3)

  • Childhood Trauma Questionnaire

    Baseline

  • Parental Bongding Instrument

    Baseline

  • The parent-child relationship intimacy scale

    Baseline

Study Arms (3)

Case group: NSSI patient group

1. Patients who meet the diagnostic criteria in DSM-5 and are clinically diagnosed as NSSI; 2. Age range: 15-25 years old; 3. Clear consciousness, normal speech function, able to communicate in Chinese and reading chinese;

Other: Questionnaires set 1

Control group 1: non-NSSI patients

1. psychiatric outpatients or inpatients can read and understand the contents of the questionnaire; 2. Patients who do not meet the diagnostic criteria in DSM-5 and are clinically diagnosed as NSSI. 3. Age range: 15-25 years old; 4. Clear consciousness, normal speech function, able to communicate in Chinese and reading chinese;

Other: Questionnaires set 2

Control group 2: healthy group

1. No mental illness; 2. Age range: 15-25 years old; 3. Clear consciousness, normal speech function, able to communicate in Chinese and reading chinese;

Other: Questionnaires set 3

Interventions

Participants of case group will be asked to respond to the demographic information,the Family Emotional Expressivity Questionnaire(FEEQ)、the Parent-Adolescent Communication Scale(PACS)、the Childhood Trauma Questionnaire(CTQ)、the Parental Bongding Instrument(PBI)、the Adolescent parent-child relationship intimacy questionnaire and the Ottawa Self-injury Inventory(OSI).

Case group: NSSI patient group

Participants of control group 1 will be asked to respond to the demographic information,the Family Emotional Expressivity Questionnaire(FEEQ)、the Parent-Adolescent Communication Scale(PACS)、the Childhood Trauma Questionnaire(CTQ)、the Parental Bongding Instrument(PBI) and the Adolescent parent-child relationship intimacy questionnaire.

Control group 1: non-NSSI patients

Participants of control group 2 will be asked to respond to the demographic information,the Family Emotional Expressivity Questionnaire(FEEQ)、the Parent-Adolescent Communication Scale(PACS)、the Childhood Trauma Questionnaire(CTQ)、the Parental Bongding Instrument(PBI) and the Adolescent parent-child relationship intimacy questionnaire.

Control group 2: healthy group

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The group of adolescents and young adults diagnosed as NSSI, and the control group includes adolescents and young adults with other mental diseases other than NSSI, healthy adolescents and young adults.

You may qualify if:

  • Patients who meet the diagnostic criteria in DSM-5 and are clinically diagnosed as NSSI;
  • Age range: 15-25 years old;
  • Clear consciousness, normal speech function, able to communicate in Chinese and reading chinese;

You may not qualify if:

  • Users with organic diseases and psychoactive substances;
  • NSSI; caused by autism, TIC disorder, mental retardation and other emotional instability and bad mood;
  • Religious self-injury or customary self-injury;
  • Patients with schizophrenia, schizoaffective disorder, alcohol dependence, organic mental disorder and other mental disorders have been previously diagnosed.
  • Control group 1: Non-NSSI patients
  • Psychiatric outpatients or inpatients can read and understand the contents of the questionnaire;
  • Patients who do not meet the diagnostic criteria in DSM-5 and are clinically diagnosed as NSSI.
  • Age range: 15-25 years old;
  • Patients and/or guardians can give informed consent and participate in this study.
  • Patients whose illness causes them unable to communicate or fill out questionnaires;
  • Non-serious mental diseases, such as schizophrenia and schizoaffective disorder.
  • Control group 2: Healthy group
  • No mental illness;
  • Age range: 15-25 years old;
  • Clear consciousness, normal speech function, able to communicate in Chinese and reading chinese;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Wei Xia, PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Liu, Master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 4, 2024

Study Start

April 1, 2024

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share