Mentalization-Based Group Therapy for Adolescents

June 3, 2019 updated by: University of Edinburgh

Efficacy of Mentalization-Based Group Therapy for Adolescents: A Pilot Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBT therapy plus treatment as usual
Mentalization based group treatment for adolescents plus standard care
Other: Mentalization-Based Group Therapy for Adolescents
No Intervention: Treatment as usual alone
Standard care provided by local Child and Adolescent Mental Health Services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010)
Time Frame: 12 weeks
12 weeks
Self-harm and related hospital use as reported in National Health Service patient records
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 13, 2016

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELHF10-595

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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