NCT02406625

Brief Summary

Suicidal behaviors among adolescents represents a public health problem due to its high prevalence and its low predictability. It is also known that brain development continues during adolescence, therefore, a therapeutic intervention during this period might propitiate neural changes that might favor the emotional regulation involved in suicidal behaviors. Dialectical Behavioral Therapy has proved to be effective regarding this problem. For this reason, the investigators aimed to study the clinical, neuropsychological and neural effects of Dialectical Behavioral Therapy in adolescents with suicidal behaviors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

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

November 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

2.3 years

First QC Date

March 19, 2015

Last Update Submit

February 16, 2017

Conditions

Suicidal Behaviors

Outcome Measures

Primary Outcomes (3)

  • Clinical changes after 16 sessions of Dialectical Behavioral Therapy.

    Clinical evaluations will be performed before and after the treatment in order to determine clinical improvement in relation to the applied therapy.

    4 months

  • Neural changes after 16 sessions of Dialectical Behavioral Therapy.

    Magnetic Resonance Imaging and functional Magnetic Resonance Imaging data sets will be acquired at baseline and then after the treatment, in order to determine anatomical or functional brain connectivity changes in relation to the applied therapy.

    4 months

  • Neuropsychological changes after 16 sessions of Dialectical Behavioral Therapy.

    Neuropsychological evaluations will be administrated before and after the treatment in order to determine changes in memory, attention or executive functioning in relation to the applied therapy.

    4 months

Study Arms (3)

Diaclectical Behavioral Therapy

EXPERIMENTAL

15 adolescents with history of suicidal behaviors receiving Dialectical Behavioral Therapy.

Behavioral: Behavioral Therapy

Support Therapy

EXPERIMENTAL

15 adolescents with history of suicidal behaviors receiving Support Therapy.

Behavioral: Behavioral Therapy

Controls

NO INTERVENTION

A group of 15 healthy controls that are not receiving any kind of therapy.

Interventions

Behavioral TherapyBEHAVIORAL

16 therapeutic group sessions are delivered to both parents and adolescents; according to the assigned group for each family.

Diaclectical Behavioral TherapySupport Therapy

Eligibility Criteria

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

You may qualify if:

  • Age between 12 and 18 years,
  • Intellectual level over 70 (IQ\>70)
  • For the experimental groups:
  • Patients with suicidal behavior:
  • Real attempt,
  • Interrupted attempt,
  • Aborted attempt or behaviors, or
  • Preparation actions (based on the Columbia Suicide Severity Rating Scale -C-SSRS criteria) present during the last 12 months and that persist in the actual moment.

You may not qualify if:

  • Presence of Acute Psychosis,
  • Eating Disorder with an BMI \< 18.5;
  • Substance abuse in the current moment or during the last 6 months;
  • Any neurological condition that curses with cognitive alterations; and
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (2)

  • 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.

    PMID: 33677832DERIVED

  • Santamarina-Perez P, Mendez I, Singh MK, Berk M, Picado M, Font E, Moreno E, Martinez E, Morer A, Borras R, Cosi A, Romero S. Adapted Dialectical Behavior Therapy for Adolescents with a High Risk of Suicide in a Community Clinic: A Pragmatic Randomized Controlled Trial. Suicide Life Threat Behav. 2020 Jun;50(3):652-667. doi: 10.1111/sltb.12612. Epub 2020 Jan 16.

    PMID: 31944371DERIVED

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

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
Ph.D.

Study Record Dates

First Submitted

March 19, 2015

First Posted

April 2, 2015

Study Start

November 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

ES(1)