跳至主要内容
临床试验/NCT02991586
NCT02991586已完成不适用

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

Hospital General Universitario Gregorio Marañon1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
Coping Styles and Strategies Scale (COPE) (Crespo 1997)

研究概览

简要总结

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.

详细描述

  • 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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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)

研究组 & 干预措施

Dialectical Behavior Therapy

Experimental

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

干预措施: Dialectical Behaviour Therapy (Behavioral)

Control

No Intervention

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

结局指标

主要结局

Coping Styles and Strategies Scale (COPE) (Crespo 1997)

时间窗: one year

Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008)

时间窗: one year

Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010)

时间窗: one year

次要结局

  • Children Relapses and Self harms Questionnaire (Ad Hoc)(one year)

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Principal Investigator
主要研究者

María Mayoral

Clinical Psychologist

Hospital General Universitario Gregorio Marañon

研究点 (1)

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