Family Connections Transdiagnostic for Relatives of People With Emotional Dysregulation

NCT07585955 | Active Not Recruiting DMC

• 2 other identifiers: 2025-PSILOG-3866898Research proyect
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relatives

Keywords

Intervention; family members; caregivers; Emotional dysregulation; Transdiagnostic; conduct disorders; eating disorders; personality disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Family Assessment Device - Global Functioning Scale (FAD-GF)

  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)

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

• Quality of Life Index (QLI)

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

• Mastery and Empowerment Scale (MES)

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

• Opinion of Treatment Scale

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

Other Outcomes (5)

• Difficulties in Emotion Regulation Scale (DERS) (for Patients)

  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)

  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)

  Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

Study Arms (2)

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

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

Behavioral: Optimized Treatment as Usual (TAU-O)

Interventions

Family Connections Transdiagnostic for relatives of people with emotional dysregulation BEHAVIORAL

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).

Family Connections Transdiagnostic for relatives of people with emotional dysregulation

Optimized Treatment as Usual (TAU-O) BEHAVIORAL

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.

Optimized Treatment as Usual (TAU-O)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (8)

• Chou HY, Lo YC, Tsai YW, Shih CL, Yeh CT. Increased Anxiety and Depression Symptoms in Post-Acute Care Patients with Stroke during the COVID-19 Pandemic. Int J Environ Res Public Health. 2021 Dec 24;19(1):162. doi: 10.3390/ijerph19010162.

  PMID: 35010420 RESULT

• Ou W, Lin L, Chen R, Xu Q, Zhou C. Circ_0081143 Contributes to Gastric Cancer Malignant Development and Doxorubicin Resistance by Elevating the Expression of YES1 by Targeting mziR-129-2-3p. Gut Liver. 2022 Nov 15;16(6):861-874. doi: 10.5009/gnl210354. Epub 2022 Jun 10.

  PMID: 35686503 RESULT

• Hieronymus K, Dorschner B, Schulze F, Vora NL, Parker JS, Winkler JL, Rosen-Wolff A, Winkler S. Validation of reference genes for whole blood gene expression analysis in cord blood of preterm and full-term neonates and peripheral blood of healthy adults. BMC Genomics. 2021 Jun 30;22(1):489. doi: 10.1186/s12864-021-07801-0.

  PMID: 34193041 RESULT

• 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.

  PMID: 39614767 RESULT

• 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.

  PMID: 39624006 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Related Links

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

MeSH Terms

Conditions

Conduct Disorder; Feeding and Eating Disorders; Personality Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 14, 2026
• Study Start: May 3, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

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

Locations

ES (1)