An interventional study of Family Connections Transdiagnostic for relatives of people with emotional dysregulation and Optimized Treatment as Usual (TAU-O) in Relatives, sponsored by University of Valencia. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by University of Valencia · Not applicable, Interventional, and Treatment
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.
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.
101 studies on the registry are indexed under Conduct Disorder; 15 are open to participants now.
This study's planned enrollment of 172 is above the median of 124 across 80 interventional studies indexed under Conduct Disorder.
Browse Conduct Disorder studies →University of Valencia is the lead sponsor of 357 studies on the registry; 75 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Being 18 years of age or older.
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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
\- 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
Usual care + psychoeducational session on ED
Behavioral: Optimized Treatment as Usual (TAU-O)
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 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.
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.
Time frame: 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.
Time frame: 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)
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.
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)
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.
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)
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.
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)
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.
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
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.
Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Plan to share: Yes — Individual participant data will be available after de-identification.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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
Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
Of 29 interventional studies with no phase under Conduct Disorder, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 68. This study's planned 7 months is below that.
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