NCT02771691

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

June 4, 2019

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

April 25, 2016

Last Update Submit

June 3, 2019

Conditions

Keywords

Adolescent

Outcome Measures

Primary Outcomes (2)

  • 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

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

    12 weeks

Study Arms (2)

MBT therapy plus treatment as usual

EXPERIMENTAL

Mentalization based group treatment for adolescents plus standard care

Other: Mentalization-Based Group Therapy for Adolescents

Treatment as usual alone

NO INTERVENTION

Standard care provided by local Child and Adolescent Mental Health Services

Interventions

MBT therapy plus treatment as usual

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAMHS

Edinburgh, Lothian, United Kingdom

Location

Related Publications (3)

  • Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.

  • Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

  • Griffiths H, Duffy F, Duffy L, Brown S, Hockaday H, Eliasson E, Graham J, Smith J, Thomson A, Schwannauer M. Efficacy of Mentalization-based group therapy for adolescents: the results of a pilot randomised controlled trial. BMC Psychiatry. 2019 Jun 6;19(1):167. doi: 10.1186/s12888-019-2158-8.

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 13, 2016

Study Start

February 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

June 4, 2019

Record last verified: 2017-11

Locations