Family Connections Transdiagnostic for Relatives of People With Emotional Dysregulation (FC-T)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Relatives
• Intervention / Treatment: Behavioral: Family Connections Transdiagnostic for relatives of people with emotional dysregulation; Behavioral: Optimized Treatment as Usual (TAU-O)

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 Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Valencia, Valencia, Spain, 46010
      • University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Connections Transdiagnostic for relatives of people with emotional dysregulation; - 12 weekly group sessions (2 hours each) Modules: Introduction and psychoeducation on ED; Development and explanatory models of ED; Emotional regulation and mindfulness; Acceptance and family environment improvement; Communication and validation; Problem-solving	Behavioral: Family Connections Transdiagnostic for relatives of people with emotional dysregulation; 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).
Active Comparator: Optimized Treatment as Usual (TAU-O); Usual care + psychoeducational session on ED	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulties in Emotion Regulation Scale (DERS) (for Patients)	It is a self-report measure assessing difficulties in emotion regulation. The Spanish adaptation includes 28 items across five dimensions (lack of emotional control, interference in goal-directed behavior, lack of emotional awareness, emotional confusion, and emotional rejection). Items are rated on a Likert scale from 1 to 5. The scale shows very good internal consistency (Cronbach's alpha ≈ .93) and good test-retest reliability (r ≈ .74).	Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Barratt Impulsiveness Scale (BIS) (for Patients)	This instrument assesses impulsivity as a multidimensional construct, including attentional, motor, and non-planning impulsivity. Items are rated on a Likert-type scale. The Spanish adaptation has demonstrated adequate psychometric properties, including good internal consistency and construct validity.	Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Family Assessment Device - Global Functioning Scale (FAD-GF) (for Patients)	It is a self-report measure of family functioning assessing domains such as communication, roles, affective involvement, and general functioning. It shows good internal consistency, with Cronbach's alpha coefficients ranging from .72 to .83 and up to .92 for general functioning.	Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Validating and Invalidating Responses Scale (VIRS) (for Patients)	It is a 16-item scale that assesses perceived validation and invalidation in caregiver responses. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (almost always). The scale has shown adequate internal consistency and construct validity in previous studies.	Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Lum Emotional Availability of Parents (LEAP) (for Patients)	It is a 15-item questionnaire that assesses perceived emotional availability of caregivers. Items are rated on a 6-point Likert scale. The instrument shows excellent internal consistency (Cronbach's alpha ≈ .92 for mothers and .93 for fathers) and good test-retest reliability (r ≈ .92 and r ≈ .85, respectively).	Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Study Chair: Laura Díaz-Sanahuja, Dr. Professor, University of Valencia; Study Chair: Cayetana Garoz, PhD, University of Castellón; Study Chair: Álvaro Cadiñanos, PhD, University of Valencia; Study Chair: Elena González-Perpiñá, PhD, University of Valencia; Study Chair: Antonio Arnal, PhD, University of Valencia; Study Chair: Ginnette Muñoz, PhD, University of Valencia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Guillen 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.

Helpful Links

• National Education Alliance for Borderline Personality Disorder" (NEABPD-SPAIN)

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2027

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: caregivers; Intervention; Transdiagnostic; eating disorders; personality disorders; family members; Emotional dysregulation; conduct disorders
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Conduct Disorder; Personality Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 2025-PSILOG-3866898; Research proyect (Other Grant/Funding Number: Generalitat Valenciana)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be available after de-identification.
• IPD Sharing Time Frame: The data will be available immediately after publication
• IPD Sharing Access Criteria: The data will be available to anyone who wishes and justify to access them
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No