- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06050486
A Mentalization-based Intervention for Children of Parent(s) With Borderline Personality Disorder
A Mentalization-based Treatment for Children (MBT-C) of Parent(s) With Borderline Personality Disorder: A Pilot Study
Background and study aims? Parents with borderline personality disorder (BPD) can present parenting difficulties such as expressions of hostility, low sensitivity, and overprotection. These parenting problems are associated with adverse outcomes for the offspring, namely, borderline features, depression, internalizing and externalizing problems, and interpersonal difficulties. Intervention studies with parent(s) who have borderline personality disorder show promising results regarding the improvement of parenting skills and parent-infant relationship. However, very few assess their effect on child's mental health and development. This study aims to evaluate the acceptability, feasibility and preliminary effectiveness of a mentalization-based clinical intervention, directed to school-aged children of mothers and/or fathers with borderline personality disorder, to reduce child mental health problems, in the short- and medium-term.
Who can participate? School-aged children (5 to 12 years of age), with mental health problems (CBCL internalizing and/or externalizing scores must be T = 60 or above), and their mothers and/or fathers (> 18 years of age) with subclinical or clinical BPD.
What does the study involve? Mother and/or father with BPD complete an online survey and an online interview. If available, the other parent and the child's teacher complete an online survey, separately. The child completes an online task with a researcher's assistance. After, participants are assigned to an intervention group (one arm, pre-posttest study). Participants receive a mentalization-based treatment for children (MBT-C), starting one week after the pre-test. MBT-C is a psychological intervention designed to resolve the child's mental health problems and promote resilience by promoting the child's and parent's mentalizing capacities. It aims to be delivered by a mental healthcare professional trained in MBT-C. In this clinical trial MBT-C will be composed of: 3 assessment sessions; 12 individual sessions with the child, plus 6 parallel individual sessions with the parent with BPD; 1 follow-up family session, 3 months after the last session. Assessment sessions are composed of one family session, one session with the child and one session with the parent. Sessions with child are in-site and sessions with parent can be on-line or in-site, according to the parents' preference. Sessions have a weekly frequency and a 50-60 minutes duration each. One week after the last intervention session participants repeat the same assessments completed before MBT-C. In addition, child and mother and/or father with BPD complete separately an online satisfaction survey and an online interview to assess participants experiences with MBT-C.
The investigators expect that after receiving MBT-C the child's mental health problems will have significantly decreased and to obtain information on the feasibility of a future large-scale clinical trial and retrospective acceptability of MBT-C with this specific population.
What are the possible benefits and risks of participating? This intervention aims to resolve child's mentals mental health problems. Patients who do not meet the inclusion criteria to participate, do not consent, or withdraw from the trial will be offered a debrief and the possibility of being referred to individualized psychological support or other if needed. If child's mental health problems are not resolve by the end of MBT-C the same possibility will be offered. At the end of MBT-C mother and/or father with BPD will be referred to individual therapy, if needed and not already receiving. Intervention with BPD parents can present challenges, such as ambivalence within the therapeutic relationship (high idealization versus therapist rejection), and high drop-out rates. To overcome these difficulties, the therapist should be knowledgeable about BPD, foster a secure-based relationship with the parent and child, and maintain an empathetic stance. It is possible for parent(s) with BPD to maltreat or abuse their children, in which case child protective services must be contacted and informed. The same procedure must be adopted in case of substantial substance abuse.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Braga, Portugal, 4710-057
- University of Minho
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria Child:
- have a mother and/or father with subclinical or clinical symptoms of BPD;
- present internalizing and/or externalizing problems (i.e., ≥60 in the internalizing and/or externalizing scale of CBCL 6-18);
- be 5-12 years old.
Inclusion Criteria Parent(s):
- have subclinical or clinical symptoms of BPD;
- have a school-aged child (5-12 years of age) with internalizing and/or externalizing problems.
Exclusion Criteria Child:
- unable to read/speak Portuguese;
- comorbidity with a neurodevelopmental disorder (i.e., autism spectrum disorder with moderate to severe impairment; moderate to severe cognitive deficit);
- doesn´t live partially or fully with parent with BPD;
- already receiving psychological counselling.
Exclusion Criteria Parent(s):
- unable to read/speak Portuguese;
- comorbidity with another mental health disorder that could interfere with intervention viability (i.e., schizophrenia spectrum or other psychotic disorders; substance-related and addictive disorders, except caffeine, tobacco and cannabis).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1: Intervention
Participants in Arm 1 receive a psychological intervention (MBT-C).
|
MBT-C is a time-limited intervention designed to resolve the child's emotional or behavioral problems and to promote resilience, by promoting the child's and parent's mentalizing capacities.
It is composed by 1) an assessment phase, composed of 3 to 4 sessions, with the family, the child and the parent(s), 2) an intervention phase, composed of a minimum block of 12 individual sessions with the child and parallel sessions for the parent(s), that can be repeated up to three times (i.e., maximum of 36 sessions), and 3) a booster session 3 to 12 months after the last session.
In this clinical trial, MBT-C will be composed of: 3 assessment sessions; 12 individual sessions with the child, plus 6 parallel individual sessions with the parent with BPD; 1 booster family session, 3 months after the last session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Behavior Checklist
Time Frame: Child is assessed with CBCL at 3 time-points: pretest (one to two weeks before the first session); posttest (one week after the last session); follow-up (3 months after the last session).
|
CBCL is a parent reported questionnaire composed of 113 items that seek to assess behavioral and emotional problems in children from 1.5 to 18 years of age.
It is a component of the Achenbach System (ASEBA).
The items are scored on a 3-point scale (0 = "Not true (as far as we know)", 1 = "Somewhat or sometimes true" and "2 = very true or often true").
It comprises three scales: (1) Internalizing problems; (2) Externalizing problems; (3) Total Score.
The cutoff point of the questionnaire is T Score = 60 or more, on all three scale, indicating a clinical level of the child's emotional and behavioral problems.
|
Child is assessed with CBCL at 3 time-points: pretest (one to two weeks before the first session); posttest (one week after the last session); follow-up (3 months after the last session).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Structured Clinical Interview for DSM-IV Axis II Personality Disorders
Time Frame: Parent is assessed at 3 time-points: pretest (one to two weeks before the first session); posttest (one week after the last session); follow-up (3 months after the last session).
|
SCID-II is a semistructured diagnostic interview that assesses 10 Axis II personality disorders from the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed (DSM-IV; APA, 2000), and the depressive and passive-aggressive personality disorders (included in DSM-IV's appendix).
It can be used to diagnose Axis II disorders categorically (present or absent) and dimensionally (according to the number of criteria met for each diagnosis).
|
Parent is assessed at 3 time-points: pretest (one to two weeks before the first session); posttest (one week after the last session); follow-up (3 months after the last session).
|
|
Emotional regulation checklist
Time Frame: Child is assessed at 3 time-points: pretest (one to two weeks before the first session); posttest (one week after the last session); follow-up (3 months after the last session).
|
ERC is a parent or teacher reported questionnaire composed of 24 items to assess emotion regulation competencies in children from 6 to 12 years of age.
The items are measured on a 4-point Likert scale (1 = never; 4 = almost always), with two subscales: emotion regulation and emotion lability/negativity.
|
Child is assessed at 3 time-points: pretest (one to two weeks before the first session); posttest (one week after the last session); follow-up (3 months after the last session).
|
|
Parental Reflective Functioning Questionnaire
Time Frame: Parent is assessed at 3 time-points: pretest (one to two weeks before the first session); posttest (one week after the last session); follow-up (3 months after the last session).
|
PRFQ is a questionnaire composed of 18 items that assesses parental reflective functioning in parents.
The items are measured on a 7-point Likert scale (1 = strongly disagree; 7 = strongly agree), composed of 3 subscales: pre-mentalizing modes of mental states, certainty about mental states, and interest and curiosity in mental states.
|
Parent is assessed at 3 time-points: pretest (one to two weeks before the first session); posttest (one week after the last session); follow-up (3 months after the last session).
|
|
Test of Emotional Comprehension
Time Frame: Child is assessed at 3 time-points: pretest (one to two weeks before the first session); posttest (one week after the last session); follow-up (3 months after the last session).
|
TEC is composed of 23 items/stories that asses 9 domains of understanding of emotions in children from 3 to 11 years of age: (1) recognition of emotions based on facial expressions, (2) external causes of emotions, (3) assigning a desire as cause an emotion; (4) the role of believes in determining emotions, (5) the influence of memory in circumstances of assessment of emotional states, (6) the ability to regulate emotions, (7) the ability to hide or conceal an emotion; (8) that a person can have mixed emotions in relation to a given situation, and (9) the role of morality in emotions.
|
Child is assessed at 3 time-points: pretest (one to two weeks before the first session); posttest (one week after the last session); follow-up (3 months after the last session).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sociodemographic Questionnaire
Time Frame: Participants are assessed with the Sociodemographic Questionnaire at 1 time-point: pretest (one to two week before the first session).
|
The Sociodemographic Questionnaire was used to collect sociodemographic information of the child and parents - such as gender, age, nationality, household members, socioeconomic level and schooling.
|
Participants are assessed with the Sociodemographic Questionnaire at 1 time-point: pretest (one to two week before the first session).
|
|
Satisfaction Questionnaire
Time Frame: Participants are assessed with the Satisfaction Questionnaires at 1 time-point: posttest (one week to two after the last session).
|
The Satisfaction Questionnaires composed of 14 items each, one for child and another for parent, that seek to assess the level of parental and child satisfaction with MBT-C.
12 Items are scored on a 5-point likert scale (1 = agree completely; 5 = disagree completely) and 2 items are of open response.
|
Participants are assessed with the Satisfaction Questionnaires at 1 time-point: posttest (one week to two after the last session).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bárbara Figueiredo, PhD, Psychology Research Centre (CIPsi), University of Minho
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEICSH 062/2021
- 2020.08588.BD (Other Grant/Funding Number: Foundation for Science and Technology (FCT))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child's Internalizing and Externalizing Problems
-
University of MinhoFoundation for Science and Technology, Portugal; Psychology Research Center... and other collaboratorsRecruitingExternalizing Problems | Internalizing ProblemsPortugal
-
Joint Child Health Project, MauritiusCompletedAntisocial | Aggressive | Externalizing Behavior Problems | Internalizing Behavior ProblemsMauritius
-
St. Justine's HospitalCanadian Institutes of Health Research (CIHR); CHU de Quebec-Universite Laval; Université de Sherbrooke and other collaboratorsActive, not recruitingNeurodevelopmental Disorders | Mental Health Issue | Externalizing Behavior Problems | Internalizing Behavior Problems | Cognitive Development | Academic AchievementCanada
-
Oregon Social Learning CenterNational Institute of Mental Health (NIMH)Not yet recruitingSocial Emotional Competence | Externalizing Behavior | Parenting Behavior | Internalizing BehaviorUnited States
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Brain... and other collaboratorsRecruitingInternalizing ProblemsNetherlands
-
Oregon Social Learning CenterOffice of Planning, Research & EvaluationActive, not recruitingParenting | Externalizing Behavior | Parent Stress | Internalizing Behavior | Child Permanency | Service UtilizationUnited States
-
Centers for Disease Control and PreventionCompletedChild Externalizing ProblemsUnited States
-
University of ChicagoNational Institute of Mental Health (NIMH)RecruitingChild Behavior Problem | Mental Health | Child Externalizing ProblemsAzerbaijan
-
University College, LondonPlace2Be; Anna FreudRecruitingDepression | Anxiety | Low Mood | Internalizing ProblemsUnited Kingdom
-
University of Illinois at ChicagoCompleted
Clinical Trials on Mentalization-based treatment for children (MBT-C)
-
Istanbul Bilgi UniversityThe Scientific and Technological Research Council of Turkey; Anna Freud National...CompletedMental Disorder, ChildTurkey
-
Universidad de ValparaisoUniversity Diego PortalesRecruiting
-
Psychiatric Research Unit, Region Zealand, DenmarkCompletedBorderline Personality DisorderDenmark
-
Eva RüfenachtNot yet recruitingBorderline Personality Disorder (BPD) | PTSD - Post Traumatic Stress DisorderSwitzerland
-
Heidelberg UniversityGerman Research Foundation; Universitätsklinikum Düsseldorf; Psychologische Hochschule... and other collaboratorsRecruitingBorderline Personality DisorderGermany
-
University Hospital HeidelbergVereinigung für analytische und tiefenpsychologisch fundierte Kinder- & Jugendlichen-...Not yet recruitingOppositional Defiant Disorder | Conduct Disorders in AdolescenceGermany
-
VIVE - The Danish Center for Social Science ResearchUniversity of Copenhagen; Anna Freud National Centre for Children and Families and other collaboratorsActive, not recruiting
-
University of NottinghamDerbyshire Healthcare NHS Foundation TrustCompletedBorderline Personality Disorder | Older Adults | Attachment | Mentalization | Mentalisation | Later LifeUnited Kingdom
-
Karolinska InstitutetCompletedBorderline Personality Disorder
-
De ViersprongActive, not recruiting