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

Domestic Violence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05917730
• Other study ID #: PIC-90-20
• Status: Active, not recruiting
• Start date: October 1, 2020
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

This clinical trial will be carried out with a group of children and adolescents who are witnesses of DV (between 8 and 16 years old). They will receive the MERITA treatment (together with TAU) and the other group will receive only TAU (control group).

The MERITA treatment consists of weekly 12 sessions of 75 minutes each. MERITA aims to improve emotional regulation and coping abilities, as well as promoting interpersonal skills and secure attachment.

After getting promising results from our previous pilot study of MERITA, the current project aims to validate, through a clinical trial with a control group, the MERIT treatment in minors who witness violence. To do this, children and adolescents who have undergone the MERIT will be compared with another group who receives other psychological and social approaches (treatment as usual), with other children and adolescents (same age and sex) who have only received treatment as usual.

The MERITA + TAU group and the TAU group will perform the following assessment: before treatment (baseline or pretreatment), after treatment (posttreatment), and at three months of follow-up. Specifically, the MERITA + TAU group will conduct two more assessments: at 6-month follow-up and one year of follow-up.

For ethical reasons, all patients will have the opportunity to use the MERITA treatment. Thus, the minors who were TAU group will go on to receive the MERITA treatment. It should be noted that these patients must have completed the 3-month visit before starting the MERITA treatment. This procedure ensures no bias when assessing the effectiveness of MERITA treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

• Patient of a Child and Youth Mental Health Center.

• Diagnosis of non-severe mental disorder according to DSM-5 (see exclusion criteria).

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Domestic Violence
• Psychotherapy, Group
• Witness

Intervention

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

Country	Name	City	State
Spain	Centre de Salut Mental Infantojuvenil	Cornellà De Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Hospital Sant Joan de Deu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic variables	Sex, age, educational level, number of visits, diagnosis.	Baseline
Other	Risk factors	Direct abuse, sexual abuse, parental mental disorder, parental alcohol abuse.	Baseline
Other	Number of attendance at MERITA sessions	As a control variable.	Immediately after the intervention
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Depressive symptoms	Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.	Baseline
Primary	Depressive symptoms	Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.	Immediately after the intervention
Primary	Depressive symptoms	Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.	3-month follow-up
Primary	Depressive symptoms	Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.	6-month follow-up
Primary	Depressive symptoms	Childhood Depression Inventory (CDI) (Kovacs, 2004). It contains two subscales: Dysphoria and Negative Self-Esteem.	12-month follow-up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Somatic complaints	List of somatic complaints (SCL) (Rieffe et al., 2006; Rieffe et al., 2007) (Górriz, Prat-Gascó, Villanueva and González, 2015).	Baseline
Secondary	Somatic complaints	List of somatic complaints (SCL) (Rieffe et al., 2006; Rieffe et al., 2007) (Górriz, Prat-Gascó, Villanueva and González, 2015).	Immediately after the intervention
Secondary	Somatic complaints	List of somatic complaints (SCL) (Rieffe et al., 2006; Rieffe et al., 2007) (Górriz, Prat-Gascó, Villanueva and González, 2015).	3-month follow-up
Secondary	Somatic complaints	List of somatic complaints (SCL) (Rieffe et al., 2006; Rieffe et al., 2007) (Górriz, Prat-Gascó, Villanueva and González, 2015).	6-month follow-up
Secondary	Somatic complaints	List of somatic complaints (SCL) (Rieffe et al., 2006; Rieffe et al., 2007) (Górriz, Prat-Gascó, Villanueva and González, 2015).	12-month follow-up
Secondary	Child/adolescents attachment with mother and father	Parental Bonding Instrument (PBI) (Parker, Tupling, and Brown, 1979). It consists of two dimensions: care and overprotection.	Baseline
Secondary	Child/adolescents attachment with mother and father	Parental Bonding Instrument (PBI) (Parker, Tupling, and Brown, 1979). It consists of two dimensions: care and overprotection.	Immediately after the intervention
Secondary	Child/adolescents attachment with mother and father	Parental Bonding Instrument (PBI) (Parker, Tupling, and Brown, 1979). It consists of two dimensions: care and overprotection.	3-month follow-up
Secondary	Child/adolescents attachment with mother and father	Parental Bonding Instrument (PBI) (Parker, Tupling, and Brown, 1979). It consists of two dimensions: care and overprotection.	6-month follow-up
Secondary	Child/adolescents attachment with mother and father	Parental Bonding Instrument (PBI) (Parker, Tupling, and Brown, 1979). It consists of two dimensions: care and overprotection.	12-month follow-up
Secondary	Family functioning	McMaster Family Assessment Device (FAD) (Epstein, Baldwin, and Bishop, 1983). It contains six dimensions: problem-solving, communication, roles, affective response, emotional involvement, behavioral control, and general family functioning.	Baseline
Secondary	Family functioning	McMaster Family Assessment Device (FAD) (Epstein, Baldwin, and Bishop, 1983). It contains six dimensions: problem-solving, communication, roles, affective response, emotional involvement, behavioral control, and general family functioning.	Immediately after the intervention
Secondary	Family functioning	McMaster Family Assessment Device (FAD) (Epstein, Baldwin, and Bishop, 1983). It contains six dimensions: problem-solving, communication, roles, affective response, emotional involvement, behavioral control, and general family functioning.	3-month follow-up
Secondary	Family functioning	McMaster Family Assessment Device (FAD) (Epstein, Baldwin, and Bishop, 1983). It contains six dimensions: problem-solving, communication, roles, affective response, emotional involvement, behavioral control, and general family functioning.	6-month follow-up
Secondary	Family functioning	McMaster Family Assessment Device (FAD) (Epstein, Baldwin, and Bishop, 1983). It contains six dimensions: problem-solving, communication, roles, affective response, emotional involvement, behavioral control, and general family functioning.	12-month follow-up