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Clinical Trials/NCT02771691
NCT02771691CompletedNot Applicable

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

University of Edinburgh1 site in 1 country53 target enrollmentStarted: February 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
53
Locations
1
Primary Endpoint
Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010)

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

MBT therapy plus treatment as usual

Experimental

Mentalization based group treatment for adolescents plus standard care

Intervention: Mentalization-Based Group Therapy for Adolescents (Other)

Treatment as usual alone

No Intervention

Standard care provided by local Child and Adolescent Mental Health Services

Outcomes

Primary Outcomes

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

Self-harm and related hospital use as reported in National Health Service patient records

Time Frame: 12 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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