Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02771691
Other study ID # ELHF10-595
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date November 2017

Study information

Verified date November 2017
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective parallel group design of group-based Mentalization-Based Therapy for Adolescents (MBT-A) through a pilot randomised controlled trial comparing group-based MBT-A plus treatment as usual (TAU) to TAU alone. As a pilot study, we aim to determine: the effectiveness of our recruitment strategies; compliance with protocol/procedures; trends towards reduced self-harm.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

- Self-harm behaviour in the past 6 months

- In receipt of treatment from local Child and Adolescent Mental Health Services

- Competent and willing to provide written, informed consent.

Exclusion Criteria:

- Severe learning disability or pervasive developmental disorder

- Acute psychotic episode

- Eating disorder in the absence of self-harm.

- Non-English speaking

- Current involvement in other ongoing treatment research

Study Design


Intervention

Other:
Mentalization-Based Group Therapy for Adolescents


Locations

Country Name City State
United Kingdom CAMHS Edinburgh Lothian

Sponsors (2)

Lead Sponsor Collaborator
University of Edinburgh NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010) 12 weeks
Primary Self-harm and related hospital use as reported in National Health Service patient records 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT02771886 - Evaluation of a Brief Surf the Urge Intervention N/A
Active, not recruiting NCT02947308 - A Study Examining Adolescents With Non-Suicidal Self-Injury
Terminated NCT04781166 - An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related Impulsivity N/A