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NCT Number: NCT02991586

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

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Provincial de Psiquiatria, Hospital General Universitario Gregorio Maranon. Calle Ibiza 43

Madrid, 28009, Spain

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dialectical Behaviour Therapy

Behavioral

Group of families

Primary outcomes

  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 outcomes

  1. Children Relapses and Self harms Questionnaire (Ad Hoc)

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Gregorio Marañon

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2016
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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