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

NCT05917730 | Active Not Recruiting

• 1 other identifier: PIC-90-20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.MERITA + TAU (intervention group)
2. 2.TAU (control group)

Conditions

Domestic Violence; Psychotherapy, Group; Witness

Keywords

Domestic Violence; Witness; Psychotherapy, Group; Clinical trial

Outcome Measures

Primary Outcomes (25)

• Post-traumatic symptoms

  Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.

  Baseline

• Post-traumatic symptoms

  Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.

  Immediately after the intervention

• Post-traumatic symptoms

  Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.

  3-month follow-up

• Post-traumatic symptoms

  Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.

  6-month follow-up

• Post-traumatic symptoms

  Children- Adolescent UCLA PTSD Index for DSM-IV (Pynoos et al., 1987). The scale is divided into four dimensions: reexperimentation, behavioral/ cognitive avoidance, cognitive/ mood alterations, and hyperactivation.

  12-month follow-up

• Anxiety symptoms

  Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.

  Baseline

• Anxiety symptoms

  Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.

  Immediately after the intervention

• Anxiety symptoms

  Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.

  3-month follow-up

• Anxiety symptoms

  Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.

  6-month follow-up

• Anxiety symptoms

  Self-Assessment Questionnaire Anxiety State / Trait in Children -STAIC- by Charles, D. Spielberger, (1982), adapted into Spanish by Seisdedos (1990). It consists of two dimensions: State Anxiety and Trait Anxiety.

  12-month follow-up

• Depressive symptoms

  Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.

  Baseline

• Depressive symptoms

  Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.

  Immediately after the intervention

• Depressive symptoms

  Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.

  3-month follow-up

• Depressive symptoms

  Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.

  6-month follow-up

• Depressive symptoms

  Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.

  12-month follow-up

• Emotional dysegulation

  Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.

  Baseline

• Emotional dysegulation

  Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.

  Immediately after the intervention

• Emotional dysegulation

  Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.

  3-month follow-up

• Emotional dysegulation

  Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.

  6-month follow-up

• Emotional dysegulation

  Scale of difficulties in emotional regulation (DERS) (Gratz and Roemer, 2004) in Spanish. These items are grouped into six subscales: non-acceptance, goals, impulsivity, strategies, awareness, and clarity.

  12-month follow-up

• Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges

  Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.

  Baseline

• Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges

  Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.

  Immediately after the intervention

• Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges

  Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.

  3-month follow-up

• Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges

  Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.

  6-month follow-up

• Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges

  Strengths and difficulties questionnaire (SDQ) (Goodman, 1997). It is grouped into five scales: emotional symptoms, behavior problems, hyperactivity/ lack of attention, peer relationship problems, and prosocial behavior.

  12-month follow-up

Secondary Outcomes (15)

• Somatic complaints

  Baseline

• Somatic complaints

  Immediately after the intervention

• Somatic complaints

  3-month follow-up

• Somatic complaints

  6-month follow-up

• Somatic complaints

  12-month follow-up

Other Outcomes (3)

• Sociodemographic variables

  Baseline

• Risk factors

  Baseline

• Number of attendance at MERITA sessions

  Immediately after the intervention

Study Arms (2)

Experimental: Emotional Regulation and Interpersonal Abilities group Therapy (MERITA).

12 sessions of 75 minutes each and are carried out weekly. MERIT aims to improve emotional regulation, to cope with problems, promoting interpersonal skills and attachment security. Sessions will be lead by two psychologists with accredited experience in MERITA.

Behavioral: Emotional Regulation and Interpersonal Abilities group Therapy (MERITA)

Control: Treatment As Usual

The treatment as usual provided in children and adolescents who witnesses DV is mainly individual psychotherapy.

Interventions

Emotional Regulation and Interpersonal Abilities group Therapy (MERITA) BEHAVIORAL

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.

Experimental: Emotional Regulation and Interpersonal Abilities group Therapy (MERITA).

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patient of a Child and Youth Mental Health Center.

You may qualify if:

• Patient of a Child and Youth Mental Health Center.

You may not qualify if:

• Witness to violence at least in the last two years. A witness to violence is defined at least one of these characteristics (Holden, 2003; Suderman 1999): a) ocular witness of the violence; b) hear violent words or acts when she is in a nearby room; c) living the consequences of the violence without him having seen or heard anything, for example, when he finds that his mother is hurt, that she cries, that she tells him what has happened and that she wants to leave the house, or when he lives the police visit.
• Informed consent of the study signed by the guardian or legal representative.
• No signing the informed consent.
• Diagnosis of autism spectrum disorder, active psychotic disorders (schizophrenia, schizophreniform, schizoaffective, brief psychotic disorder, induced psychotic disorder), and severe eating disorder.
• Reason for consultation of forensic evaluation.
• Lack of clear collaboration of adults.
• IQ \< 70.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Hospital Sant Joan de Deu: collaborator

Study Sites (1)

Centre de Salut Mental Infantojuvenil

Cornellà de Llobregat, Barcelona, 08940, Spain

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: June 26, 2023
• Study Start: October 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)