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Effectiveness Study of a Dialectical Behavioral Treatment for Families of Adolescents With Emotional Instability (FAL)

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ClinicalTrials.gov Identifier: NCT02991586
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
María Mayoral, Hospital General Universitario Gregorio Marañon

Brief Summary:

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.

The purpose of the study is 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.

To evaluate the effectiveness of the DBT family group intervention, it is compared with a group of non-treatment or "treatment as usual" (outpatient treatment and parents without children specific group treatment). 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.

The result of these interventions will be measured after the end of treatment and after 6 and 12 months after the treatment ends. The variables considered are family communication, cognitive skills, emotional and behavioral coping clinical in parents and as indirect measures of change in adolescents health resources used as , suicidal gestures, self-harm or aggressive behavior.


Condition or disease Intervention/treatment Phase
Emotional Instability Behavioral: Dialectical Behaviour Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness Study of a Dialectical Behavioral Treatment for Families of Adolescents With Emotional Instability
Study Start Date : May 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2020

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



Primary Outcome Measures :
  1. Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008) [ Time Frame: one year ]
  2. Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010) [ Time Frame: one year ]
  3. Coping Styles and Strategies Scale (COPE) (Crespo 1997) [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Children Relapses and Self harms Questionnaire (Ad Hoc) [ Time Frame: one year ]


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991586


Contacts
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Contact: Maria Mayoral, PhD +34 914265005 maria.mayoral@iisgm.com

Locations
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Spain
Instituto Provincial de Psiquiatria, Hospital General Universitario Gregorio Maranon. Calle Ibiza 43 Recruiting
Madrid, Spain, 28009
Contact: Maria Mayoral, PhD    914265005    maria.mayoral@iisgm.com   
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Investigators
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Principal Investigator: Maria Mayoral, PhD Gregorio Marañon Hospital

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Responsible Party: María Mayoral, Clinical Psychologist, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT02991586     History of Changes
Other Study ID Numbers: FALGregorioMaranon
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by María Mayoral, Hospital General Universitario Gregorio Marañon:
Emotional Instability
Family Therapy
BPD
DBT