Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05917730
Other study ID # PIC-90-20
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03037749 - Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence N/A
Completed NCT02606344 - Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV N/A
Completed NCT03482687 - It's Your Game: An Innovative Approach to Preventing Teen Dating Violence N/A
Active, not recruiting NCT00847548 - Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting N/A
Completed NCT01207258 - Brief Intervention for Problem Drinking and Partner Violence Phase 2
Completed NCT00983593 - A Randomized Clinical Study of a Mind-Body Approach to Domestic Violence Offender Treatment N/A
Completed NCT01621334 - The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use Phase 1
Completed NCT01803932 - Evaluation of a Male-focused Intervention to Prevent Intimate Partner Violence in a Conflict-affected Setting N/A
Completed NCT00289939 - Reducing HIV & Domestic Violence Risk in Women Offenders Phase 3
Completed NCT05598697 - Economic Evaluation of the MEWE Intervention N/A
Not yet recruiting NCT03672942 - Communication Skills vs. Mindfulness for IPV N/A
Completed NCT03883932 - Fatherhood Focused Family Violence Education Program N/A
Completed NCT05129501 - The Impact of an Adapted Version of the Strengthening Families Program on IPV Among Caregivers and ACEs Among Children N/A
Enrolling by invitation NCT05139069 - Using Implementation Science to Increase Pre-Exposure Prophylaxis Uptake Among African American Women N/A
Recruiting NCT03198429 - Cluster RCT of Embedded Parenting Intervention to Prevent Recurrence and Reduce Impairment in Young Children Exposed to Domestic Violence N/A
Completed NCT04125251 - Men Engagement in Women Empowerment for Improving Maternal Mental Health Through Cash Transfer and Life Skills Building N/A
Active, not recruiting NCT03236948 - RCT of the Effectiveness of the WfWI Intervention in Afghanistan Phase 3
Completed NCT02258841 - Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence N/A
Completed NCT01958554 - Impact of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence Phase 2
Completed NCT01688427 - Perinatal Nurse Home Visiting Enhanced With mHealth Technology N/A