Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families

May 23, 2022 updated by: María Mayoral, Hospital General Universitario Gregorio Marañon

Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families. Comparison of Family Functioning and Cope Strategies in Adolescents With Emotional Instability and Their Families and a Control Group

Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health resources, coupled with the suffering of families who feel helpless and difficulties in handling.

this study is composed of three diferents studies:

. The first study's goal is to determine if there are diferences and, which ones, between family functioning and cope strategies between adolescents with IE and their families, and families of a control group.

  • the purpose of the second study is to evaluate the effectivenes of a dialectical behavior therapy for adolescents with IE and their families who are in treatment in the Child Abd Adolescent Mental Heath Service of the Hospital sant Joan de Déu Terres de Lleida. This treatment consist on 2 preliminary sessions with parents and patients and 12 group sessions which purpose is to teach skilss to manage emotions based on dialectical Behavior Therapy.
  • finally, the third study is designed to evaluate the effectiveness of a dialectical behavior therapy (DBT) for parents of adolescents with IE who are in treatment in the different network devices of Child and Adolescent Mental Health of the Community of Madrid. Treatment goals are the development of communication skills, validation and crisis management as well as increase understanding and competence of the pathology. The DBT intervention will begin with two individual sessions with parents of patients and 10 theoretical and practical seminars in group format (6-7 families) following the model proposed by Marsha Linehan. The DBT interventions will be added to "standard treatment" that a patient with IE receives in the investigative devices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • In the first study, case group is composed by patients with IE and their families, both from Madrid and Lérida. The control group is composed by adolescents without mental pathologies, recruited from some high scholls from Madrid and Lérida.
  • In the second study, the results will be measured a after the end of treatment and 6 months after the treatment ends.

In the third study, the results will be measured a after the end of treatment and 6 months after the treatment ends.

Study Type

Interventional

Enrollment (Actual)

96

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

  • Spain
      • Madrid, Spain, 28009
        • Instituto Provincial de Psiquiatria, Hospital General Universitario Gregorio Maranon. Calle Ibiza 43

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 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parents of patients aged 12-17 years whose child is at least 3 criteria of borderline personality disorder ( Diagnostic and Statistical Manual of Mental Disorders 5 ) .
  • Talk correctly Spanish correctly.
  • Coexistence with son and willingness to participate in the groups.
  • Informed consent.

Exclusion Criteria:

  • Mental retardation.
  • Being involved in some other structured DBT family intervention.
  • Parents whose children are not receiving any treatment .
  • Participated in Actions for Treatment of Personality in Adolescence (ATRAPA TAI)

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: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dialectical Behavior Therapy
Dialectical Behavior Therapy (DBT) is a cognitive behavioral treatment that was originally developed to treat chronically suicidal individuals diagnosed with borderline personality disorder (BPD) and it is now recognized as the gold standard psychological treatment for this population. In addition, research has shown that it is effective in treating a wide range of other disorders such as substance dependence, depression, post-traumatic stress disorder (PTSD), and eating disorders. In this research DBT skills will be taught to parents of adolescents with high emotional instability
Behavioral: Dialectical Behaviour Therapy
Group of families
NO_INTERVENTION: Control
Control: The "No intervention arm" in this research is defined as follow:, sons and daughters are in their respective treatment but parents are nor receiving any DBT intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008)
Time Frame: one year
one year
Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010)
Time Frame: one year
one year
Coping Styles and Strategies Scale (COPE) (Crespo 1997)
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Children Relapses and Self harms Questionnaire (Ad Hoc)
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Hospital General Universitario Gregorio Marañon

Investigators

  • Principal Investigator: Maria Mayoral, PhD, Gregorio Marañon hospital

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

May 1, 2016

Primary Completion (ACTUAL)

January 1, 2022

Study Completion (ACTUAL)

April 1, 2022

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (ESTIMATE)

December 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FALGregorioMaranon

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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