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RelativesNCT05157607

Family Connections for Caregivers of People With Suicidal Behavior

A study testing Family Connections Protocol for Relatives of Patients with SBD. and Treatment as Usual Optimized Protocol (TAU-O) in people with Relatives, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Relatives
What is being tested?
Family Connections Protocol for Relatives of Patients with SBD. and Treatment as Usual Optimized Protocol (TAU-O)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteSpain
Study dates
15 Nov 2021to 1 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Valencia

    Valencia, 46010

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions
Relatives
Being tested
Family Connections Protocol for Relatives of Patients with SBD., Treatment as Usual Optimized Protocol (TAU-O)
Keywords
Family Connections, Suicidal Behavior Disorder, Suicide Attempts, Caregivers, Dialectical Behavior Therapy
Medical subject headings
Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Connections Protocol for Relatives of Patients with SBD.Behavioural

    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)Behavioural

    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.

Study groups in NCT05157607
Study groupRoleWhat they receive
Family Connections Protocol for Relatives of Patients with SBD.ExperimentalThe 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.
Receives: Behavioral: Family Connections Protocol for Relatives of Patients with SBD.
Treatment as Usual Optimized Protocol (TAU-O).Active comparatorFamily 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.
Receives: Behavioral: Treatment as Usual Optimized Protocol (TAU-O)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. 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.

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

  2. 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)

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

  3. 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

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

  4. 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).

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

  5. 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".

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

  6. 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.).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2021
  2. Study start15 Nov 2021
  3. Primary completion1 Apr 2023
  4. Study completion1 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Control Trial, efficacy Study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05157607
Sponsor's protocol ID
UV-1623849
Status last verified
May 2026
First submitted
1 Dec 2021
Last updated
26 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be available after deidentification

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.

    PubMed 17257517

  • 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.

    PubMed 16013747

  • 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.

    PubMed 14979218

  • 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.

    PubMed 10668619

  • 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.

    PubMed 28861273

  • 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.

    PubMed 19590999

  • 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.

    PubMed 31463066

  • Marco-Salvador JH, Perez-Rodriguez S, Diaz-Sanahuja L, Grau A, Paredes-Mealla M, Guillen V. Dialectical behavioral therapy-based skills training program for family members of suicide attempters: a randomized controlled trial. Borderline Personal Disord Emot Dysregul. 2026 Jun 13. doi: 10.1186/s40479-026-00353-3. Online ahead of print.

    PubMed 42288925

  • 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.

    PubMed 35570289

Questions about this trial

What is this clinical trial studying?

A study testing Family Connections Protocol for Relatives of Patients with SBD. and Treatment as Usual Optimized Protocol (TAU-O) in people with Relatives, run by University of Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05157607, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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