Family Connections for Caregivers of People With Suicidal Behavior

NCT05157607 | Unknown DMC

• 1 other identifier: UV-1623849
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Relatives

Keywords

Family Connections; Suicidal Behavior Disorder; Suicide Attempts; Caregivers; Dialectical Behavior Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Family empowerment scale (FES)

  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)

  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

  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)

  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)

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

Other Outcomes (6)

• Register of critical incidents with the patient member with SBD

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

• Interpersonal Needs Questionnaire (INQ)

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

• Patient Health Questionnaire (PHQ-9)

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

Study Arms (2)

Family Connections Protocol for Relatives of Patients with SBD.

EXPERIMENTAL

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.

Treatment as Usual Optimized Protocol (TAU-O).

ACTIVE COMPARATOR

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)

Interventions

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.

Family Connections Protocol for Relatives of Patients with SBD.

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.

Treatment as Usual Optimized Protocol (TAU-O).

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a caregiver of one patient with a diagnosis of Suicide Behavior Disorder
• Understand spoken and written Spanish;
• Signing the informed consent.

You may not qualify if:

• The presence of a diagnosis of severe mental disorder in the caregivers as: Psychosis, schizophrenia, substance dependence, or high suicide ideation.

Sponsors & Collaborators

• University of Valencia: lead
• Universitat Jaume I: collaborator

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (8)

• 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.

  PMID: 17257517 BACKGROUND

• 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.

  PMID: 16013747 BACKGROUND

• 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.

  PMID: 14979218 BACKGROUND

• 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.

  PMID: 10668619 BACKGROUND

• 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.

  PMID: 28861273 BACKGROUND

• 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.

  PMID: 19590999 BACKGROUND

• 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.

  PMID: 31463066 BACKGROUND

• 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.

  PMID: 35570289 DERIVED

MeSH Terms

Conditions

Suicide, Attempted

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Isabel Fernández Felipe, PhDStudent

  Universitat Jaume I

  PRINCIPAL INVESTIGATOR

• Sara Fonseca, PhDStudent

  University of Valencia

  PRINCIPAL INVESTIGATOR

• Azucena Garcia-Palacios, PhD

  Universitat Jaume I

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial, efficacy Study

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 15, 2021
• Study Start: November 15, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be available immediately following publication
• Access Criteria: The data will be available to anyone who wishes to access them.

Locations

ES (1)