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

Emotional Instability Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991586
• Other study ID #: FALGregorioMaranon
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 2022

Study information

• Verified date: May 2022
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Emotional Instability

Intervention

Behavioral:
• Dialectical Behaviour Therapy
Group of families

Locations

Country	Name	City	State
Spain	Instituto Provincial de Psiquiatria, Hospital General Universitario Gregorio Maranon. Calle Ibiza 43	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008)		one year
Primary	Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010)		one year
Primary	Coping Styles and Strategies Scale (COPE) (Crespo 1997)		one year
Secondary	Children Relapses and Self harms Questionnaire (Ad Hoc)		one year