Clinical trial NCT05917730: Manual of Emotional Regulation and Interpersonal Abilities in Children and Adolescents Group Therapy
Official title: Clinical Trial for Promoting Emotional Regulation and Interpersonal Skills (MERITA) in Children and Adolescents Witnesses of Domestic Violence
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Domestic Violence
Psychotherapy, Group
Witness
Keywords: Domestic Violence
Witness
Psychotherapy, Group
Clinical trial
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Hospital Sant Joan de Deu
First posted: 2023-06-26
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient of a Child and Youth Mental Health Center.

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. 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-traumatic symptoms
timeFrame: Baseline
measure: Post-traumatic symptoms
timeFrame: Immediately after the intervention
measure: Post-traumatic symptoms
timeFrame: 3-month follow-up
measure: Post-traumatic symptoms
timeFrame: 6-month follow-up
measure: Post-traumatic symptoms
timeFrame: 12-month follow-up
measure: Anxiety symptoms
timeFrame: Baseline
measure: Anxiety symptoms
timeFrame: Immediately after the intervention
measure: Anxiety symptoms
timeFrame: 3-month follow-up
measure: Anxiety symptoms
timeFrame: 6-month follow-up
measure: Anxiety symptoms
timeFrame: 12-month follow-up
measure: Depressive symptoms
timeFrame: Baseline
measure: Depressive symptoms
timeFrame: Immediately after the intervention
measure: Depressive symptoms
timeFrame: 3-month follow-up
measure: Depressive symptoms
timeFrame: 6-month follow-up
measure: Depressive symptoms
timeFrame: 12-month follow-up
measure: Emotional dysegulation
timeFrame: Baseline
measure: Emotional dysegulation
timeFrame: Immediately after the intervention
measure: Emotional dysegulation
timeFrame: 3-month follow-up
measure: Emotional dysegulation
timeFrame: 6-month follow-up
measure: Emotional dysegulation
timeFrame: 12-month follow-up
measure: Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
timeFrame: Baseline
measure: Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
timeFrame: Immediately after the intervention
measure: Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
timeFrame: 3-month follow-up
measure: Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
timeFrame: 6-month follow-up
measure: Internalizing and externalizing symptoms, prosocial behavior, and interpersonal challenges
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Somatic complaints
timeFrame: Baseline
measure: Somatic complaints
timeFrame: Immediately after the intervention
measure: Somatic complaints
timeFrame: 3-month follow-up
measure: Somatic complaints
timeFrame: 6-month follow-up
measure: Somatic complaints
timeFrame: 12-month follow-up
measure: Child/adolescents attachment with mother and father
timeFrame: Baseline
measure: Child/adolescents attachment with mother and father
timeFrame: Immediately after the intervention
measure: Child/adolescents attachment with mother and father
timeFrame: 3-month follow-up
measure: Child/adolescents attachment with mother and father
timeFrame: 6-month follow-up
measure: Child/adolescents attachment with mother and father
timeFrame: 12-month follow-up
measure: Family functioning
timeFrame: Baseline
measure: Family functioning
timeFrame: Immediately after the intervention
measure: Family functioning
timeFrame: 3-month follow-up
measure: Family functioning
timeFrame: 6-month follow-up
measure: Family functioning
timeFrame: 12-month follow-up
Other outcomes:
measure: Sociodemographic variables
timeFrame: Baseline
measure: Risk factors
timeFrame: Baseline
measure: Number of attendance at MERITA sessions
timeFrame: Immediately after the intervention
Locations:
city: Cornellà De Llobregat
country: Spain
facility: Centre de Salut Mental Infantojuvenil
state: Barcelona
Study officials:
References: