Clinical trial NCT04481425: Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI
Official title: Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-suicidal Self-injury
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 86
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: In this proposed study, the investigators will evaluate the effect of text message intervention on Nonsuicidal self-injury behavior in adolescents. The study will recruit 110 adolescents with Nonsuicidal self-injury behavior in outpatient and ward, then all the participants will be randomized to the intervention group (55 cases) or the control group 55 cases) for an 8-week clinic trial. Clinical efficacy and safety assessment will be done at baseline, the fourth week, and the eighth week. The specific aims are to evaluate the effect of text message intervention on NSSI in adolescents are on 1) Tendency and frequency of Nonsuicidal self-injury behavior; 2) Level of negative emotion such as depression, anxiety, and hopelessness 3) The use of emotion regulation strategies and coping styles. A semi-structured quantitative interview will be conducted among adolescents from the SMS group to get the attitude and experiences feedback about the text message.

Eligibility criteria: Inclusion Criteria:

1. Adolescents aged 10-19 years old.
2. Meet the diagnostic criteria of NSSI behavior recommended by DSM-5.
3. The adolescents who have mobile phone, and have the ability to send or receive text messages.
4. Adolescents and guardians agreed to participate and signed the informed consent form

Exclusion Criteria:

1. Adolescents with severe somatic diseases who cannot complete the study.
2. Adolescents with cognitive impairment, neurodevelopmental disorder, mental retardation, visual impairment who cannot complete the study.
3. The adolescents who do not have a mobile phone.

Primary outcomes:
measure: The change of NSSI behavior of the participants.
timeFrame: At baseline, the fourth week, the eighth week
Secondary outcomes:
measure: The change of anxiety level.
timeFrame: At baseline, the fourth week, the eighth week
measure: The change of depression level.
timeFrame: At baseline, the fourth week, the eighth week
measure: The change of hopelessness.
timeFrame: At baseline, the fourth week, the eighth week
measure: The change of emotion regulation strategies.
timeFrame: At baseline, the fourth week, the eighth week
measure: The change of coping styles.
timeFrame: At baseline, the fourth week, the eighth week
measure: The change of life events stress.
timeFrame: At baseline, the fourth week, the eighth week
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Psychiatry, Xiangya Second Hospital, Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Jianjun Ou, doctor
role: STUDY_CHAIR
affiliation: Central South University
name: Runsen Chen, doctor
role: STUDY_DIRECTOR
References: