NCT04481425

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

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

December 23, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

July 13, 2020

Last Update Submit

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

OTHER

Text 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.

Other: SMS intervention

control group

NO INTERVENTION

Subjects both collected in the outpatient department and the ward were randomly divided into the control group and regularly followed up.

Interventions

SMS intervention

intervention group

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Location

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jianjun Ou, doctor

    Central South University

    STUDY CHAIR
  • Runsen Chen, doctor

    Central South University

    STUDY DIRECTOR

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

Locations