RelativesFC-TNCT07585955
Family Connections Transdiagnostic for Relatives of People With Emotional Dysregulation
A study testing Family Connections Transdiagnostic for relatives of people with emotional dysregulation and Optimized Treatment as Usual (TAU-O) in people with Relatives, run by University of Valencia at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the efficacy of the Family Connections Transdiagnostic (FC-T) program in relatives of individuals with psychological disorders associated with emotional dysregulation through a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Relatives
- What is being tested?
- Family Connections Transdiagnostic for relatives of people with emotional dysregulation and Optimized Treatment as Usual (TAU-O)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSpain
- Study dates
- 3 May 2026to 25 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Being 18 years of age or older.
- Being a family member (e.g., parent, partner, sibling, or other close relative) of a patient diagnosed, according to the 5th version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), with a psychological disorder characterized by emotional dysregulation (e.g., eating disorders, Cluster B personality disorders, or disruptive, impulse-control, and conduct disorders).
- The patient must currently be receiving treatment in a participating clinical center.
- Having sufficient knowledge and understanding of the Spanish language to complete the assessments and participate in the intervention.
- Providing written informed consent to participate in the study.
Who cannot join
- • Presence of any severe mental disorder or condition in the family member that may interfere with participation in the intervention (e.g., psychotic disorders, schizophrenia, severe cognitive impairment, or intellectual disability).
- Current substance dependence that may hinder participation in the study.
- Severe clinical instability in the patient that prevents the family member from participating in the intervention (as judged by clinicians).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family Connections Transdiagnostic: Study Protocol for a Randomized Controlled Trial Evaluating Efficacy in Relatives of People With Emotional Dysregulation
The aim of this study is to evaluate the efficacy of the Family Connections Transdiagnostic (FC-T) program in relatives of individuals with psychological disorders associated with emotional dysregulation through a randomized controlled trial.
Read the detailed description
Emotional dysregulation (ED) is a core transdiagnostic process characterized by heightened emotional sensitivity, intense emotional responses, and difficulties returning to baseline emotional states. It is present across a wide range of psychological disorders, including eating disorders (EDs), Cluster B personality disorders (PD), and disruptive, impulse-control, and conduct disorders. These conditions are associated with significant impairments in social functioning and are often accompanied by psychological symptoms such as depression, anxiety, interpersonal difficulties, and reduced quality of life. In addition, maladaptive strategies to cope with emotional distress (e.g., self-harm, impulsivity, aggression, binge eating) contribute to the maintenance and severity of these disorders.
Families of individuals with psychological disorders characterized by ED experience a high burden of illness and frequently report elevated levels of psychological distress, including anxiety and depression, as well as impairments in their own quality of life. Despite their key role as primary caregivers, family members often lack the necessary skills to effectively manage emotional crises and daily challenges, which may contribute to dysfunctional family dynamics and increased conflict. Although some intervention programs have been developed for caregivers of specific disorders, there is currently a lack of transdiagnostic treatments specifically designed for relatives of individuals with ED.
A skills training program called "Family Connections" (FC) was developed by Hoffman and Fruzzetti's group for relatives of individuals with borderline personality disorder (BPD). It is a program consisting of 12 weekly two-hour sessions delivered in a group format. It is divided into six modules that include psychoeducation about the disorder and its impact on family functioning, as well as skills adapted from Dialectical Behavior Therapy, such as mindfulness, emotion regulation, validation, radical acceptance, and problem management, among others. In addition, all modules include practical exercises, video examples, and homework assignments. Previous studies have shown that this program leads to significant reductions in caregiver burden, perceived distress, depression, and anxiety, as well as improvements in coping strategies and family functioning.
The present study aims to develop and evaluate a transdiagnostic adaptation of the program (Family Connections Transdiagnostic; FC-T), designed to be applied to relatives of individuals with psychological disorders characterized by emotional dysregulation, regardless of specific diagnosis. The psychoeducational modules will be adapted to address ED as a common underlying mechanism, while maintaining the core skills training components of the original program.
The aims of this study are the following: (a) to adapt and test, in the Spanish population, the modules of the FC-T intervention protocol for relatives of patients with psychological disorders characterized by ED; (b) to test the efficacy of FC-T in reducing caregiver burden and clinical symptomatology and improving family relationships and quality of life; (c) to test its efficiency, understood as the acceptance of the intervention program by participants and clinicians, and to demonstrate its feasibility; and (d) to carry out an effective dissemination of this protocol.
This paper presents the study protocol. The study design consists of a two-arm randomized controlled trial with two conditions: Family Connections Transdiagnostic (FC-T) or Treatment as usual optimized (TAU-O). Participants will be family members of patients diagnosed, according to the 5th version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), with eating disorders, Cluster B personality disorders, or disruptive, impulse-control, and conduct disorders. The caregivers' primary outcome measures will be the Burden Assessment Scale (BAS) and a Family-Patient Critical Incident Record. Secondary outcomes will include measures of family functioning, clinical symptomatology, coping strategies, and quality of life. Patient-related outcomes will include measures of emotional dysregulation and impulsivity. Participants will be assessed at pre-treatment, post-treatment, and twelve-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 Transdiagnostic for relatives of people with emotional dysregulation, Optimized Treatment as Usual (TAU-O)
- Keywords
- Intervention, family members, caregivers, Emotional dysregulation, Transdiagnostic, conduct disorders, eating disorders, personality disorders
- Medical subject headings
- Conduct Disorder, Feeding and Eating Disorders, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Connections Transdiagnostic for relatives of people with emotional dysregulationBehavioural
The intervention lasts 3 months and includes 12 two-hour sessions in a group format on a weekly basis. The FC-T program is divided into 6 modules: 2 modules of psychoeducation on emotional dysregulation (ED) and 4 modules of Dialectical Behavior Therapy (DBT)-based skills training (relationship mindfulness, emotional regulation, acceptance, validation, and problem management).
Optimized Treatment as Usual (TAU-O)Behavioural
Family members will receive the usual care available in their clinical setting. In addition, they will participate in a single 3-hour group psychoeducation session including the following components: (1) up-to-date information and research on emotional dysregulation (epidemiology, frequency, comorbidity, risk and protective factors); and (2) psychoeducation on the development of emotional dysregulation, explanatory models, and available treatments.
| Study group | Role | What they receive |
|---|---|---|
| Family Connections Transdiagnostic for relatives of people with emotional dysregulation | Experimental | - 12 weekly group sessions (2 hours each)
Modules:
1. Introduction and psychoeducation on ED
2. Development and explanatory models of ED
3. Emotional regulation and mindfulness
4. Acceptance and family environment improvement
5. Communication and validation
6. Problem-solving Receives: Behavioral: Family Connections Transdiagnostic for relatives of people with emotional dysregulation |
| Optimized Treatment as Usual (TAU-O) | Active comparator | Usual care + psychoeducational session on ED Receives: Behavioral: Optimized Treatment as Usual (TAU-O) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record of critical family-patient incidents
Frequency of problem behaviors in the past 3 months, including suicide attempts, self-harm episodes, visits to psychiatric emergency services, episodes of binge eating, substance use (alcohol or drugs), stealing, fire-setting, verbal aggression, and physical aggression.
Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Burden Assessment Scale (BAS)
It is a 19-item scale that assesses the caregiver's objective and subjective burden due to the illness of their relative within the past six months using a 4-point Likert scale ranging from 1 (not at all) to 4 (a lot). Higher scores indicate greater caregiver burden. The scale shows adequate validity and reliability, with Cronbach's alpha coefficients ranging from .89 to .91.
Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Secondary outcomes (5)
Family Assessment Device - Global Functioning Scale (FAD-GF)
It is a 60-item self-report measure of family functioning assessing domains such as communication, roles, affective involvement, and general functioning. Items are rated on a 4-point Likert scale. The instrument shows good internal consistency, with Cronbach's alpha coefficients ranging between .72 and .83 for subscales and around .92 for general functioning.
Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Depression, Anxiety and Stress Scale (DASS-21)
It is a 21-item scale that measures clinical symptoms such as depression, anxiety, and stress. Items are rated on a 4-point Likert scale ranging from 0 (did not apply to me) to 3 (applied to me most of the time). It shows excellent internal consistency, with Cronbach's alpha coefficients of approximately .94 for depression, .87 for anxiety, and .91 for stress.
Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Quality of Life Index (QLI)
This instrument assesses perceived quality of life across several domains, including health, psychological well-being, and social relationships. Higher scores indicate better quality of life. The Spanish version has demonstrated adequate reliability and validity, with good internal consistency indices.
Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Mastery and Empowerment Scale (MES)
It is a 34-item scale that evaluates coping strategies, perceived control, and empowerment across family, service system, and community domains. Items are rated on a 5-point Likert scale. Previous studies have demonstrated robust psychometric properties, including good internal consistency and construct validity across different samples.
Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Opinion of Treatment Scale
This scale assesses participants' satisfaction, acceptance, and perceived usefulness of the intervention program. It evaluates aspects such as satisfaction, perceived effectiveness, and willingness to recommend the program. Items are rated on a Likert-type scale ranging from 0 to 10. This measure has been adapted from previous treatment opinion scales and shows adequate face validity for assessing treatment acceptability.
Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start3 May 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for RelativesStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- This study aims to adapt FC into a transdiagnostic format (FC-T) and evaluate its efficacy compared to Optimized Treatment as Usual (TAU-O).This is an efficacy study conducted as a randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Verónica Guillén-Botella, University of Valencia
- Investigators
- Laura Díaz-Sanahuja, Dr. Professor, Study chair, University of ValenciaCayetana Garoz, PhD, Study chair, University of CastellónÁlvaro Cadiñanos, PhD, Study chair, University of ValenciaElena González-Perpiñá, PhD, Study chair, University of ValenciaAntonio Arnal, PhD, Study chair, University of ValenciaGinnette Muñoz, PhD, Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585955
- Sponsor's protocol ID
- 2025-PSILOG-3866898
- Other IDs
- Research proyect
- Acronym
- FC-T
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 28 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 de-identification.
Publications
Guillen V. Psychological interventions for family members of people with psychological disorders with emotional dysregulation: Introduction to special section. Fam Process. 2024 Dec;63(4):2087-2098. doi: 10.1111/famp.13090. Epub 2024 Nov 30.
PubMed 39614767Guillen V, Fernandez-Felipe I, Marco JH, Grau A, Botella C, Garcia-Palacios A. "Family Connections", a program for relatives of people with borderline personality disorder: A randomized controlled trial. Fam Process. 2024 Dec;63(4):2195-2214. doi: 10.1111/famp.13089. Epub 2024 Dec 3.
PubMed 39624006Flynn 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 28861273Hoffman 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 17257517Hoffman 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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Connections Transdiagnostic: Study Protocol for a Randomized Controlled Trial Evaluating Efficacy in Relatives of People With Emotional Dysregulation
- ClinicalTrials.gov ID
- NCT07585955
- Acronym / sponsor ID
- FC-T / 2025-PSILOG-3866898
- Conditions
- Relatives
- Keywords
- Intervention, family members, caregivers, Emotional dysregulation, Transdiagnostic, conduct disorders, eating disorders, personality disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 3 May 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2027 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the efficacy of the Family Connections Transdiagnostic (FC-T) program in relatives of individuals with psychological disorders associated with emotional dysregulation through a randomized controlled trial.
Detailed description
Emotional dysregulation (ED) is a core transdiagnostic process characterized by heightened emotional sensitivity, intense emotional responses, and difficulties returning to baseline emotional states. It is present across a wide range of psychological disorders, including eating disorders (EDs), Cluster B personality disorders (PD), and disruptive, impulse-control, and conduct disorders. These conditions are associated with significant impairments in social functioning and are often accompanied by psychological symptoms such as depression, anxiety, interpersonal difficulties, and reduced quality of life. In addition, maladaptive strategies to cope with emotional distress (e.g., self-harm, impulsivity, aggression, binge eating) contribute to the maintenance and severity of these disorders.
Families of individuals with psychological disorders characterized by ED experience a high burden of illness and frequently report elevated levels of psychological distress, including anxiety and depression, as well as impairments in their own quality of life. Despite their key role as primary caregivers, family members often lack the necessary skills to effectively manage emotional crises and daily challenges, which may contribute to dysfunctional family dynamics and increased conflict. Although some intervention programs have been developed for caregivers of specific disorders, there is currently a lack of transdiagnostic treatments specifically designed for relatives of individuals with ED.
A skills training program called "Family Connections" (FC) was developed by Hoffman and Fruzzetti's group for relatives of individuals with borderline personality disorder (BPD). It is a program consisting of 12 weekly two-hour sessions delivered in a group format. It is divided into six modules that include psychoeducation about the disorder and its impact on family functioning, as well as skills adapted from Dialectical Behavior Therapy, such as mindfulness, emotion regulation, validation, radical acceptance, and problem management, among others. In addition, all modules include practical exercises, video examples, and homework assignments. Previous studies have shown that this program leads to significant reductions in caregiver burden, perceived distress, depression, and anxiety, as well as improvements in coping strategies and family functioning.
The present study aims to develop and evaluate a transdiagnostic adaptation of the program (Family Connections Transdiagnostic; FC-T), designed to be applied to relatives of individuals with psychological disorders characterized by emotional dysregulation, regardless of specific diagnosis. The psychoeducational modules will be adapted to address ED as a common underlying mechanism, while maintaining the core skills training components of the original program.
The aims of this study are the following: (a) to adapt and test, in the Spanish population, the modules of the FC-T intervention protocol for relatives of patients with psychological disorders characterized by ED; (b) to test the efficacy of FC-T in reducing caregiver burden and clinical symptomatology and improving family relationships and quality of life; (c) to test its efficiency, understood as the acceptance of the intervention program by participants and clinicians, and to demonstrate its feasibility; and (d) to carry out an effective dissemination of this protocol.
This paper presents the study protocol. The study design consists of a two-arm randomized controlled trial with two conditions: Family Connections Transdiagnostic (FC-T) or Treatment as usual optimized (TAU-O). Participants will be family members of patients diagnosed, according to the 5th version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), with eating disorders, Cluster B personality disorders, or disruptive, impulse-control, and conduct disorders. The caregivers' primary outcome measures will be the Burden Assessment Scale (BAS) and a Family-Patient Critical Incident Record. Secondary outcomes will include measures of family functioning, clinical symptomatology, coping strategies, and quality of life. Patient-related outcomes will include measures of emotional dysregulation and impulsivity. Participants will be assessed at pre-treatment, post-treatment, and twelve-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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study aims to adapt FC into a transdiagnostic format (FC-T) and evaluate its efficacy compared to Optimized Treatment as Usual (TAU-O).This is an efficacy study conducted as a randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Family Connections Transdiagnostic for relatives of people with emotional dysregulation | Experimental | Behavioral: Family Connections Transdiagnostic for relatives of people with emotional dysregulation- 12 weekly group sessions (2 hours each) Modules: 1. Introduction and psychoeducation on ED 2. Development and explanatory models of ED 3. Emotional regulation and mindfulness 4. Acceptance and family environment improvement 5. Communication and validation 6. Problem-solving |
| Optimized Treatment as Usual (TAU-O) | Active comparator | Behavioral: Optimized Treatment as Usual (TAU-O)Usual care + psychoeducational session on ED |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Being 18 years of age or older.
Key exclusion criteria (3 listed)
- • Presence of any severe mental disorder or condition in the family member that may interfere with participation in the intervention (e.g., psychotic disorders, schizophrenia, severe cognitive impairment, or intellectual disability).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Connections Transdiagnostic for relatives of people with emotional dysregulationThe intervention lasts 3 months and includes 12 two-hour sessions in a group format on a weekly basis. The FC-T program is divided into 6 modules: 2 modules of psychoeducation on emotional dysregulation (ED) and 4 modules of Dialectical Behavior Therapy (DBT)-based skills training (relationship mindfulness, emotional regulation, acceptance, validation, and problem management). | Behavioural | Family Connections Transdiagnostic for relatives of people with emotional dysregulation |
| Optimized Treatment as Usual (TAU-O)Family members will receive the usual care available in their clinical setting. In addition, they will participate in a single 3-hour group psychoeducation session including the following components: (1) up-to-date information and research on emotional dysregulation (epidemiology, frequency, comorbidity, risk and protective factors); and (2) psychoeducation on the development of emotional dysregulation, explanatory models, and available treatments. | Behavioural | Optimized Treatment as Usual (TAU-O) |
Primary outcome
Record of critical family-patient incidents
Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Frequency of problem behaviors in the past 3 months, including suicide attempts, self-harm episodes, visits to psychiatric emergency services, episodes of binge eating, substance use (alcohol or drugs), stealing, fire-setting, verbal aggression, and physical aggression.
Burden Assessment Scale (BAS)
Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
It is a 19-item scale that assesses the caregiver's objective and subjective burden due to the illness of their relative within the past six months using a 4-point Likert scale ranging from 1 (not at all) to 4 (a lot). Higher scores indicate greater caregiver burden. The scale shows adequate validity and reliability, with Cronbach's alpha coefficients ranging from .89 to .91.
5 secondary outcomes
Family Assessment Device - Global Functioning Scale (FAD-GF)
Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Depression, Anxiety and Stress Scale (DASS-21)
Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Quality of Life Index (QLI)
Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Mastery and Empowerment Scale (MES)
Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Opinion of Treatment Scale
Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Results publication: PubMed 39614767Guillen V. Psychological interventions for family members of people with psychological disorders with emotional dysregulation: Introduction to special section. Fam Process. 2024 Dec;63(4):2087-2098. doi: 10.1111/famp.13090. Epub 2024 Nov 30.
- Results publication: PubMed 39624006Guillen V, Fernandez-Felipe I, Marco JH, Grau A, Botella C, Garcia-Palacios A. "Family Connections", a program for relatives of people with borderline personality disorder: A randomized controlled trial. Fam Process. 2024 Dec;63(4):2195-2214. doi: 10.1111/famp.13089. Epub 2024 Dec 3.
- Results publication: PubMed 28861273Flynn 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.
- Results publication: PubMed 17257517Hoffman 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.
- Results publication: PubMed 16013747Hoffman 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.
- National Education Alliance for Borderline Personality Disorder" (NEABPD-SPAIN)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data will be available after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Díaz-Sanahuja, Dr. Professor study chair
University of Valencia
Cayetana Garoz, PhD study chair
University of Castellón
Álvaro Cadiñanos, PhD study chair
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Connections Transdiagnostic for relatives of people with emotional dysregulation and Optimized Treatment as Usual (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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 28 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?
This study is still under way. Results are not available in the source record yet.
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?
Record of critical family-patient incidents (time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up). The study lists 2 primary outcomes in all. 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 NCT07585955, which also lists 5 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 28 May 2026.