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Completed

NCT Number: NCT05157607

Family Connections for Caregivers of People With Suicidal Behavior

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family Connections Protocol for Relatives of Patients with SBD.

Behavioral

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.

Treatment as Usual Optimized Protocol (TAU-O)

Behavioral

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.

Primary outcomes

  1. Burden assessment scale (BAS)

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

    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.

Secondary outcomes

  1. Family empowerment scale (FES)

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

    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.

  2. Depression, anxiety, and stress scale (DASS-21)

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

    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)

  3. Difficulties in emotion regulation scale - Spanish version

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

    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

  4. Quality of life index-Spanish version (QLI-Sp)

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

    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).

  5. Opinion and Expectations of Treatment Scale (OTSM)

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention

    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".

  6. Register of critical incidents with the family member with SBD

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

    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.).

Other outcomes

  1. Register of critical incidents with the patient member with SBD

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

    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.).

  2. Interpersonal Needs Questionnaire (INQ)

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

    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).

  3. Patient Health Questionnaire (PHQ-9)

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

    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

  4. Overall Anxiety Severity and Impairment Scale (OASIS

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

    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).

  5. Validating and Invalidating Responses Scale (VIRS)

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

    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).

  6. Lum Emotional Availability of Parents

    Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.

    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).

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Funding for the study was provided by (R + D + I) Projects of the State Programs Oriented to the Challenges of Society, within the framework of the State Resear
  • Universitat Jaume I

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 15, 2021
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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