Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI
1 other identifier
interventional
86
1 country
1
Brief Summary
In this proposed study, Text messages are used to intervene in the NSSI behavior of adolescents, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of adolescents' NSSI behavior is discussed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
1 active site
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
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
July 22, 2020
CompletedStudy Start
First participant enrolled
December 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2022
CompletedNovember 18, 2022
November 1, 2022
1.1 years
July 13, 2020
November 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The change of NSSI behavior of the participants.
NSSI behavior will be measured by Nonsuicidal self-injury Questionnaire which contains several items designed by investigators. The questionnaire is mainly used to measure the frequency of NSSI among adolescents.
At baseline, the fourth week, the eighth week
Secondary Outcomes (6)
The change of anxiety level.
At baseline, the fourth week, the eighth week
The change of depression level.
At baseline, the fourth week, the eighth week
The change of hopelessness.
At baseline, the fourth week, the eighth week
The change of emotion regulation strategies.
At baseline, the fourth week, the eighth week
The change of coping styles.
At baseline, the fourth week, the eighth week
- +1 more secondary outcomes
Study Arms (2)
intervention group
OTHERText messages will be sent to the subjects through the investigator, including giving popularization of psychiatric knowledge, coping skills, emotional regulation strategies, and brief care. Two or three times a week for two months.
control group
NO INTERVENTIONSubjects both collected in the outpatient department and the ward were randomly divided into the control group and regularly followed up.
Interventions
Eligibility Criteria
You may qualify if:
- Adolescents aged 10-19 years old.
- Meet the diagnostic criteria of NSSI behavior recommended by DSM-5.
- The adolescents who have mobile phone, and have the ability to send or receive text messages.
- Adolescents and guardians agreed to participate and signed the informed consent form
You may not qualify if:
- Adolescents with severe somatic diseases who cannot complete the study.
- Adolescents with cognitive impairment, neurodevelopmental disorder, mental retardation, visual impairment who cannot complete the study.
- The adolescents who do not have a mobile phone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry, Xiangya Second Hospital, Central South University
Changsha, Hunan, 410000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianjun Ou, doctor
Central South University
- STUDY DIRECTOR
Runsen Chen, doctor
Central South University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 13, 2020
First Posted
July 22, 2020
Study Start
December 23, 2020
Primary Completion
January 30, 2022
Study Completion
January 30, 2022
Last Updated
November 18, 2022
Record last verified: 2022-11