Family Connections for Caregivers of People With Suicidal Behavior

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Relatives
• Intervention / Treatment: Behavioral: Family Connections Protocol for Relatives of Patients with SBD.; Behavioral: Treatment as Usual Optimized Protocol (TAU-O)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Connections Protocol for Relatives of Patients with SBD.; 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.; 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.
Active Comparator: Treatment as Usual Optimized Protocol (TAU-O).; 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); 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.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Register of critical incidents with the patient member with SBD	This 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.
Interpersonal Needs Questionnaire (INQ)	We use the Spanish version of this 15-item questionnaire that assesses the degree of dissatisfaction with their need to belong (frustrated belonging) and the degree to which they perceive themselves as a burden to others (perceived burden). The items are rated on a Likert-type scale (1-7) where higher scores indicate higher levels of frustrated belonging and perceived burden to others. Psychometric properties were good: scale reliability was very good (perceived burden, α = 0.96; and frustrated belonging, α = 0.78).	Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
Patient Health Questionnaire (PHQ-9)	It consists of a nine-item questionnaire that assesses depressive symptoms in the past two weeks. Specifically, it includes the DSM-IV diagnostic criteria A for major depressive disorder (American Psychiatric Association, 2000). The items are rated on a Likert scale (0-3) where higher scores indicate higher frequency of depressive symptoms. The severity of depression on this questionnaire is measured through the total score, which can be categorized as none or minimal, mild, moderate, moderately severe, and severe. Validity has been adequate, with a sensitivity of 88% and a specificity of 88% for major depression	Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
Overall Anxiety Severity and Impairment Scale (OASIS	We use the Spanish version of this questionnaire, which consists of a five-item instrument that assesses the frequency and intensity of anxiety symptoms in the past week. In addition, it measures interference in work and academic, social, and daily life domains, as well as avoidance behaviors. The items are rated on a Likert-type scale (0-4). The psychometric properties are good in terms of internal consistency (α= 0.86), convergent and discriminant validity, and sensitivity to change (α= 0.86).	Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
Validating and Invalidating Responses Scale (VIRS)	It consists of a 16-item scale on the validation and invalidation of family members' responses about their loved ones. It is divided into two subscales (validation and invalidation), and the items are rated on a Likert scale (0-4) where higher scores indicate higher perceived validation or higher perceived invalidation (depending on the subscale).	Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
Lum Emotional Availability of Parents	This 15-item questionnaire measures the perceived emotional availability of primary caregivers. The items are rated on a Likert scale (1-6) where higher scores indicate greater emotional availability of caregivers. Psychometric properties were excellent for both subscales (mother, α = .9; and father, α = .93). In addition, test-retest reliability was also adequate for the mother's subscale (r = .92) and the father's subscale (r = .85).	Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Universitat Jaume I
• Investigators: Principal Investigator: Isabel Fernández Felipe, PhDStudent, Universitat Jaume I; Principal Investigator: Sara Fonseca, PhDStudent, University of Valencia; Principal Investigator: Sandra Perez, PhD, Universitat de Valencia; Principal Investigator: Rosa Baños, PhD, Universitat de Valencia; Principal Investigator: Cristina Botella Arbona, PhD, Universitat Jaume I; Principal Investigator: Joaquin Garcia-Alandete, PhD, Universitat de Valencia

Publications and helpful links

General Publications

• Hoffman PD, Fruzzetti AE. Advances in interventions for families with a relative with a personality disorder diagnosis. Curr Psychiatry Rep. 2007 Feb;9(1):68-73. doi: 10.1007/s11920-007-0012-z.
• Hoffman PD, Fruzzetti AE, Buteau E, Neiditch ER, Penney D, Bruce ML, Hellman F, Struening E. Family connections: a program for relatives of persons with borderline personality disorder. Fam Process. 2005 Jun;44(2):217-25. doi: 10.1111/j.1545-5300.2005.00055.x.
• Hoffman PD, Buteau E, Hooley JM, Fruzzetti AE, Bruce ML. Family members' knowledge about borderline personality disorder: correspondence with their levels of depression, burden, distress, and expressed emotion. Fam Process. 2003 Winter;42(4):469-78. doi: 10.1111/j.1545-5300.2003.00469.x.
• Hoffman PD, Fruzzetti AE, Swenson CR. Dialectical behavior therapy--family skills training. Fam Process. 1999 Winter;38(4):399-414. doi: 10.1111/j.1545-5300.1999.00399.x.
• Flynn D, Kells M, Joyce M, Corcoran P, Herley S, Suarez C, Cotter P, Hurley J, Weihrauch M, Groeger J. Family Connections versus optimised treatment-as-usual for family members of individuals with borderline personality disorder: non-randomised controlled study. Borderline Personal Disord Emot Dysregul. 2017 Aug 30;4:18. doi: 10.1186/s40479-017-0069-1. eCollection 2017.
• Rajalin M, Wickholm-Pethrus L, Hursti T, Jokinen J. Dialectical behavior therapy-based skills training for family members of suicide attempters. Arch Suicide Res. 2009;13(3):257-63. doi: 10.1080/13811110903044401.
• Liljedahl SI, Kleindienst N, Wangby-Lundh M, Lundh LG, Daukantaite D, Fruzzetti AE, Westling S. Family Connections in different settings and intensities for underserved and geographically isolated families: a non-randomised comparison study. Borderline Personal Disord Emot Dysregul. 2019 Aug 26;6:14. doi: 10.1186/s40479-019-0111-6. eCollection 2019.
• Marco JH, Fonseca S, Fernandez-Felipe I, Garcia-Palacios A, Banos R, Perez S, Garcia-Alandete J, Guillen V. Family connections vs treatment at usual optimized in the treatment of relatives of people with suicidal behavior disorder: study protocol of a randomized control trial. BMC Psychiatry. 2022 May 15;22(1):335. doi: 10.1186/s12888-022-03965-5.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Caregivers; Family Connections; Suicidal Behavior Disorder; Suicide Attempts; Dialectical Behavior Therapy
• Other Study ID Numbers: UV-1623849

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data will be available after deidentification
• IPD Sharing Time Frame: The data will be available immediately following publication
• IPD Sharing Access Criteria: The data will be available to anyone who wishes to access them.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No