AdolescentsNCT06290115
Adolescents' Non-suicidal Behavior and Perception of Parents' Negative Emotional Expression and Family Communication
An observational study of Adolescents, run by Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescents
- What is being tested?
- Questionnaires set 1, Questionnaires set 2 and Questionnaires set 3
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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;
- 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;
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- Patients and/or guardians can give informed consent and participate in this study.
- No mental illness;
- Age range: 15-25 years old;
- Clear consciousness, normal speech function, able to communicate in Chinese and reading chinese;
- Patients and/or guardians can give informed consent and participate in this study.
Who cannot join
- 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.
- 2.Control group 1: Non-NSSI patients
- Patients whose illness causes them unable to communicate or fill out questionnaires;
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- Non-serious mental diseases, such as schizophrenia and schizoaffective disorder.
- 3.Control group 2: Healthy group
- Young people and adolescents who are unable to communicate or fill out questionnaires due to various organic reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Relationship Between Non-suicidal Self-injury Behaviors in Adolescents and Young Adults and Perceived Parental Negative Emotional Expression and Family Communication Styles in Children:A Case-control Study
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.
Read the detailed description
The incidence of non-suicidal self-injury（NSSI） among adolescents has obviously increased, which should attract the attention of the whole society. Their mental health problems will not only lead to personal pain and family burden, but also bring potential negative effects to future social development. Therefore, it is necessary to study the psychological problems of teenagers and their influencing factors. This study will conduct a case-control study from the perspective of family, and analyze the negative emotional expression and family communication style of parents of non-suicidal teenagers and their influence on non-suicidal self-injury behavior. This study is conducted in the form of scale, which will use 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）.
- Conditions
- Adolescents
- Being tested
- Questionnaires set 1, Questionnaires set 2, Questionnaires set 3
- Keywords
- Adolescents and Young Adults, Non-suicidal self-injury, Parental emotional expressivity, Family communication patterns
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires set 1Other
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）.
Questionnaires set 2Other
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.
Questionnaires set 3Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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; Receives: 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; Receives: Other: Questionnaires set 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
Childhood Trauma Questionnaire
There are 28 items in the Childhood Trauma Scale, which are used to measure childhood traumatic experiences. The scale adopts Likert 5-point system, and the higher the score, the more serious the childhood trauma experience.
Measured: Baseline
Parental Bongding Instrument
There are 23 items in the Parenting Style Scale, which is used to measure the parenting style. The scale adopts Likert 4-point system, which consists of three factors: caring, encouraging autonomy and controlling.
Measured: Baseline
The parent-child relationship intimacy scale
There are 29 items in the parent-child relationship intimacy scale, which are used to measure the parent-child relationship. The scale adopts Likert 5-point system, and the higher the score, the higher the intimacy of parent-child relationship.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290115
- Sponsor's protocol ID
- 202301
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Non-suicidal Self-injury Behaviors in Adolescents and Young Adults and Perceived Parental Negative Emotional Expression and Family Communication Styles in Children:A Case-control Study
- ClinicalTrials.gov ID
- NCT06290115
- Acronym / sponsor ID
- 202301
- Conditions
- Adolescents
- Keywords
- Adolescents and Young Adults, Non-suicidal self-injury, Parental emotional expressivity, Family communication patterns
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The incidence of non-suicidal self-injury（NSSI） among adolescents has obviously increased, which should attract the attention of the whole society. Their mental health problems will not only lead to personal pain and family burden, but also bring potential negative effects to future social development. Therefore, it is necessary to study the psychological problems of teenagers and their influencing factors. This study will conduct a case-control study from the perspective of family, and analyze the negative emotional expression and family communication style of parents of non-suicidal teenagers and their influence on non-suicidal self-injury behavior. This study is conducted in the form of scale, which will use 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）.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case group: NSSI patient group | – | Other: Questionnaires set 11. 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; |
| Control group 1: non-NSSI patients | – | Other: Questionnaires set 21. 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; |
| Control group 2: healthy group | – | Other: Questionnaires set 31. No mental illness; 2. Age range: 15-25 years old; 3. Clear consciousness, normal speech function, able to communicate in Chinese and reading chinese; |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (11 listed)
- 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;
- 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.
Key exclusion criteria (9 listed)
- 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.
- 2.Control group 1: Non-NSSI patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires set 1Participants 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）. | Other | Case group: NSSI patient group |
| Questionnaires set 2Participants 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. | Other | Control group 1: non-NSSI patients |
| Questionnaires set 3Participants 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. | Other | Control group 2: healthy group |
Primary outcome
Non-suicidal self-injury behavior of young people and adolescents
Time frame: Baseline
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.
Expression of negative emotions of parents
Time frame: Baseline
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.
Parent-Adolescent communication scale
Time frame: Baseline
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.
3 secondary outcomes
Childhood Trauma Questionnaire
Time frame: Baseline
Parental Bongding Instrument
Time frame: Baseline
The parent-child relationship intimacy scale
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xia, PhD principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescents, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wei Xia, PhD (18823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-suicidal self-injury behavior of young people and adolescents (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.