Clinical trial NCT05157607: Family Connections for Caregivers of People With Suicidal Behavior
Official title: Family Connections for Caregivers of People With Suicidal Behavior: Study Protocol of a Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Relatives
Keywords: Family Connections
Suicidal Behavior Disorder
Suicide Attempts
Caregivers
Dialectical Behavior Therapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Universitat Jaume I
First posted: 2021-12-15
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial, efficacy Study
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Burden assessment scale (BAS)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
Secondary outcomes:
measure: Family empowerment scale (FES)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Depression, anxiety, and stress scale (DASS-21)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Difficulties in emotion regulation scale - Spanish version
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Quality of life index-Spanish version (QLI-Sp)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Opinion and Expectations of Treatment Scale (OTSM)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention
measure: Register of critical incidents with the family member with SBD
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
Other outcomes:
measure: Register of critical incidents with the patient member with SBD
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Interpersonal Needs Questionnaire (INQ)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Overall Anxiety Severity and Impairment Scale (OASIS
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Validating and Invalidating Responses Scale (VIRS)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
measure: Lum Emotional Availability of Parents
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up.
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: Universitat Jaume I
name: Isabel Fernández Felipe, PhDStudent
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Sara Fonseca, PhDStudent
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Jaume I
name: Azucena Garcia-Palacios, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat de Valencia
name: Sandra Perez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat de Valencia
name: Rosa Baños, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Jaume I
name: Cristina Botella Arbona, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat de Valencia
name: Joaquin Garcia-Alandete, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.