Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05917730

Manual of Emotional Regulation and Interpersonal Abilities in Children and Adolescents Group Therapy

Sponsor: Fundació Sant Joan de Déu

View on ClinicalTrials.gov

Summary

Purpose: Domestic violence (DV) is a mental health problem that affects children and adolescents. Widespread evidence suggests that witnessing DV has physical and mental health consequences. 19% of children and adolescents cared for in Children, and Youth Mental Health Centers in Catalonia declare having witnessed DV between their parents. However, there are low specialized therapeutic tools to intervene effectively. In this line, the research team of the current project adapted and manualized a group treatment designed to treat children and adolescents between 8 and 16 years old witnesses of DV on an outpatient basis called: 'Manual of Emotional Regulation and Interpersonal Abilities group Therapy - MERITA'. The treatment main aim is to improve the emotional regulation and interpersonal skills of children and adolescents who have witnessed DV. We carried out a pilot study of MERITA (Lacasa et al., 2016) where we obtained promising results. Now, we want to carry out this study to improve methodological limitations by increasing the sample size. We have added a waiting list for assigning patients in different arms (MERITA intervention vs. treatment as usual as control group), as well as we improved the assessment (pre, post, and follow-ups) using several scales with good psychometric properties. Aims: The aim of this trial is twofold: firstly, to assess the effectiveness of Emotional Regulation and Interpersonal Abilities group Therapy (MERITA) in children and adolescents who are witnesses of DV and treated at the Infant and dolescent mental health center (TAU); and secondly, to analyze the differences (MERITA vs only TAU) on traumatic, depressive and anxious symptomatology, emotional dysregulation, interpersonal difficulties, externalizing and internalizing symptoms, somatic complaints, prosocial behavior, attachment, and family functioning. Specifically, MERITA will be compared to TAU alone (post and 3-month follow-up). Methods Design: Trail with two arms: 1. MERITA + TAU (intervention group) 2. TAU (control group) Sample: The necessary sample size to detect statistically significant differences between the groups has been calculated using the G\*Power: with a minimum effect size (0.50), a significance level of 5% and a power of 80%. A minimum of 36 participants would be required.

Official title: Clinical Trial for Promoting Emotional Regulation and Interpersonal Skills (MERITA) in Children and Adolescents Witnesses of Domestic Violence

Key Details

Gender

All

Age Range

8 Years - 16 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2020-10-01

Completion Date

2024-06

Last Updated

2024-04-22

Healthy Volunteers

No

Interventions

BEHAVIORAL

Emotional Regulation and Interpersonal Abilities group Therapy (MERITA)

Therapy sessions Block 1. Recognition and verbalization of emotions: Session 1: Presentation, framing, and beginning of identification and denomination of emotions. Session 2: Recognition and differentiation of emotions. Session 3 and 4: Effects of traumatic experiences. Block 2. Learning to manage emotions: Session 5: Managing unpleasant emotions, coping Abilities in body, mind, and behavior. Session 6: New coping skills, self-esteem. Session 7: New coping skills, self-care. Session 8: Skills for clear communication. Session 9: Assertiveness and reciprocity. Session 10: Save card and the good relations game/negotiation skills. Session 11: Social skills and confidence recovery. Session 12: Consolidation and farewell.

Locations (1)

Centre de Salut Mental Infantojuvenil

Cornellà de Llobregat, Barcelona, Spain