Family Connections for Caregivers of People With Suicidal Behavior

Study Overview
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Brief Summary
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The aim of our study is to verify the efficacy of the Family Connections intervention for relatives of people diagnosed with suicidal behavior disorder in a randomized control trial with a Spanish participants.

Detailed Description
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Family members of people who have attempted suicide feel guilty, afraid, hopeless, depression and anxiety. The needs of family members of people with suicide attempts are not adequately addressed in the current treatments for people with suicide attempts. Therefore, it is necessary to help the relatives of people with suicidal behaviors to reduce the discomfort and burden they experience by giving them information and skills to improve their relationship with patients. Family Connections (FC) is a program that has been shown to be effective in reducing burden, depression, and anxiety, and in increasing dominance and validating behaviors in relatives of people with borderline personality disorder. However, there are no Randomized Control Trials that demonstrate the efficacy of FC program in patients with suicide attempts. In a previous study, FC was adapted in an open trial with relatives of people who had attempted suicide. The results of this pilot study suggest that the FC program tailored to relatives of patients with suicide attempts may be effective in improving well-being and reducing the burden of illness in relatives. Our research team adapted FC for relatives of people diagnosed with suicidal behavior disorder (SBD) for delivery in the Spanish population. The FC-SCD program contains 12 two-hour sessions held once a week. The first aim is to verify the efficacy of the FC intervention for relatives of people diagnosed with SBD in a randomized control trial with a Spanish sample of participants from mental health services. The second objective is to analyze the feasibility and acceptance of FC-SBD in relatives. The third aim is to analyze whether the changes produced in the psychological variables in the relatives after the intervention are related to changes in the psychological variables of the patients. This paper presents the study protocol. The study design consists of a two-arm randomized controlled trial, there will be two conditions: Family Connections (FC-SBD) or Treatment as usual optimized (TAU-O). Participants will be relatives of patients who meet DSM-5 criteria for SBD. The caregivers' primary outcome measures will be the BAS. Secondary outcomes will be DASS-21, FES, DERS, QoL. The patient's primary outcome measures will be the INQ, PHQ-9, OASIS, VIRS, LUMP. Participants will be assessed at pretreatment, post-treatment, and 6-month follow-up. The intention-to-treat principle will be used when analyzing data, using mixed-effects models with full information and maximum likelihood estimation.

Official Title
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Family Connections for Caregivers of People With Suicidal Behavior: Study Protocol of a Randomized Control Trial.

Conditions
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Relatives

Intervention / Treatment
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* Behavioral: Family Connections Protocol for Relatives of Patients with SBD.
* Behavioral: Treatment as Usual Optimized Protocol (TAU-O)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being a caregiver of one patient with a diagnosis of Suicide Behavior Disorder Understand spoken and written Spanish; Signing the informed consent. Exclusion Criteria: The presence of a diagnosis of severe mental disorder in the caregivers as: Psychosis, schizophrenia, substance dependence, or high suicide ideation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial, efficacy Study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Connections Protocol for Relatives of Patients with SBD.<br>The intervention lasts three months and includes 12 sessions with a weekly two-hour group format. The FC program is divided into six modules: Module 1: Up-to-date information and research on suicide (Epidemiology, frequency, Risk factors, protective factors). Module 2: Psychoeducation on the development of suicide, explanatory theories, available treatments, comorbidity. Module 3: Emotional regulation skills, skills of acceptance, validation, approach, awareness, and to decrease emotional reactivity. Module 4: Skills to improve the quality of relationships in family interactions (letting go of guilt and anger, acceptance skills in relationships). Module 5: Communication skills and effective self-expression. Module 6: Problem management and making safe plans for crisis management. | Behavioral: Family Connections Protocol for Relatives of Patients with SBD.<br>* Family Connections is a Dialectical Behavioral Therapy. All the modules include practice exercises, video viewing, and homework assignments. In addition, throughout the program, with the aim of increasing social support, the FC-SBD program provides a forum where participants can stay in touch and share common problems and solutions.<br>|
| Active Comparator: Treatment as Usual Optimized Protocol (TAU-O).<br>Family members in this condition will continue to receive their treatment as usual in their care center of reference. In addition, we will optimize the treatment based on the recommendations of the international guidelines for the treatment of suicide. There will be one three-hour session in group format with the following component: Module 1: Updated information and research on suicide (Epidemiology, frequency, Risk factors, protective factors). Psychoeducation on the development of Suicide, Explanatory theories. Available treatments, and comorbidity. | Behavioral: Treatment as Usual Optimized Protocol (TAU-O)<br>* Participants will receive the usual treatment in their mental health service and will also receive a psychoeducation session of approximately 3 hours where the predictive and protective factors of suicidal behavior will be explained.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burden assessment scale (BAS) | This 19-item scale assesses two dimensions of caregiver burden of a loved one's illness (objective and subjective) in the past six months. The items are rated on a 4-point Likert scale (1-4), where higher scores indicate higher levels of illness burden. The psychometric properties of this scale are adequate, with an internal reliability between .89 and .91 and adequate validity. | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Family empowerment scale (FES) | This scale has a total of 34 items. It is composed of three subscales referring to attitudes, knowledge, and behaviors related to (1) Family, (2) the Service System, and (3) Community Participation. The items are rated on a Likert scale (1-5), where higher scores show greater feelings of empowerment. Both the validity and reliability of this scale are adequate, and the internal consistency of the subscales shows coefficients between α = .87 and α =.88. | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | 
| Depression, anxiety, and stress scale (DASS-21) | We have used the short, validated Spanish version with 21 items on the frequency of negative emotional symptoms in the past week. The items are rated on a Likert scale (0-3) where the higher the score, the higher the frequency of symptoms of depression, anxiety, and/or stress. The internal consistency of the scale was excellent, with Cronbach's alphas for the DASS-21 subscales: Depression (α = .94), Anxiety (α = .87) and Stress (α = .91) | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | 
| Difficulties in emotion regulation scale - Spanish version | We used the Spanish validation containing 28 items. This questionnaire is divided into five subscales: (1) Lack of emotional control, (2) Life interference, (3) Emotional inattention, (4) Emotional confusion, and (5) Emotional rejection. The items are rated on a Likert scale (1-5) where higher scores indicate greater difficulty in regulating emotions. Psychometric properties are excellent, with an internal consistency of α = .93 and test-retest reliability of pl = .74, p < .001 | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | 
| Quality of life index-Spanish version (QLI-Sp) | It consists of a 10-item index of perceived quality of life. It refers to physical and emotional well-being, functioning at work, satisfaction with personal relationships and self-independence, support in the community and from an emotional point of view, spiritual well-being, and perceived overall quality of life. The items are rated on a Likert scale (0-10) where higher scores indicate higher perceived quality of life. The psychometric properties are good for both internal consistency (α = .89) and test-retest reliability (r = 0.87). | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | 
| Opinion and Expectations of Treatment Scale (OTSM) | This scale was designed and developed by members of the research team and constructed from an adaptation of another opinion and expectations questionnaire [49]. The constructs this scale assesses are: opinion, acceptance and satisfaction with the skills training program, and the changes in the participants after the completion of each module. The questions refer to the rationale for the intervention, recommendation of the program, satisfaction with the program, usefulness and expectations of the skills training. The items are rated on a Likert-type scale ranging from 0 Not at all to 10 Very much. | Changes will be assessed from pre-treatment to immediately after the intervention | 
| Register of critical incidents with the family member with SBD | his register was developed ad hoc for this study. The questions recorded are the following: frequency of suicide attempts in the past six months, number of days of self-harm in the past six months, number of episodes of verbal/physical violence with caregivers in the past six months; frequency of visits to the psychiatric emergency room in the past six months, frequency of therapy sessions conducted out of schedule in the past six months (face-to-face, phone calls, etc.). | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family Connections, Suicidal Behavior Disorder, Suicide Attempts, Caregivers, Dialectical Behavior Therapy