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A Mentalization-based Intervention for Children of Parent(s) With Borderline Personality Disorder

Primary Purpose

Child's Internalizing and Externalizing Problems

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Mentalization-based treatment for children (MBT-C)
Sponsored by
University of Minho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child's Internalizing and Externalizing Problems

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Child: 1) have a mother and/or father with subclinical or clinical symptoms of BPD; 2); present internalizing and/or externalizing problems (i.e., ≥60 in the internalizing and/or externalizing scale of CBCL 6-18); and 3) be 5-12 years old. Parent(s): 1) have subclinical or clinical symptoms of BPD; 2) have a school-aged child (5-12 years of age) with internalizing and/or externalizing problems. Exclusion Criteria: Child: 1) unable to read/speak Portuguese; 2) comorbidity with a neurodevelopmental disorder (e.g., autism spectrum disorder); 3) doesn´t live partially or fully with parent with BPD; and 4) already receiving psychological counselling. Parent(s): 1) unable to read/speak Portuguese; and 2) 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).

Sites / Locations

  • University of MinhoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1: Intervention

Arm Description

Participants in Arm 1 receive a psychological intervention (MBT-C).

Outcomes

Primary Outcome Measures

Child Behavior Checklist (CBCL 1.5-5 and CBCL 6-18; Achenbach et al., 2014)
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.

Secondary Outcome Measures

Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II; Pinto-Gouveia et al., 2011)
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).
Emotional regulation checklist (ERC; Sousa et al., 2021)
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.
Parental Reflective Functioning Questionnaire (PRFQ ; Moreira & Fonseca, 2021)
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.
Test of Emotional Comprehension (TEC; Rocha et al., 2013)
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.

Full Information

First Posted
September 15, 2023
Last Updated
September 15, 2023
Sponsor
University of Minho
Collaborators
Psychology Research Center (CIPsi)
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1. Study Identification

Unique Protocol Identification Number
NCT06050486
Brief Title
A Mentalization-based Intervention for Children of Parent(s) With Borderline Personality Disorder
Official Title
A Mentalization-based Treatment for Children (MBT-C) of Parent(s) With Borderline Personality Disorder: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Minho
Collaborators
Psychology Research Center (CIPsi)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. We 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child's Internalizing and Externalizing Problems

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The interventional model is a simple one-arm study (intervention), with 3 assessment waves (pretest, posttest and follow-up).
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Intervention
Arm Type
Experimental
Arm Description
Participants in Arm 1 receive a psychological intervention (MBT-C).
Intervention Type
Behavioral
Intervention Name(s)
Mentalization-based treatment for children (MBT-C)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child Behavior Checklist (CBCL 1.5-5 and CBCL 6-18; Achenbach et al., 2014)
Description
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.
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).
Secondary Outcome Measure Information:
Title
Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II; Pinto-Gouveia et al., 2011)
Description
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).
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).
Title
Emotional regulation checklist (ERC; Sousa et al., 2021)
Description
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.
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).
Title
Parental Reflective Functioning Questionnaire (PRFQ ; Moreira & Fonseca, 2021)
Description
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.
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).
Title
Test of Emotional Comprehension (TEC; Rocha et al., 2013)
Description
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.
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).
Other Pre-specified Outcome Measures:
Title
Sociodemographic Questionnaire
Description
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.
Time Frame
Participants are assessed with the Sociodemographic Questionnaire at 1 time-point: pretest (one to two week before the first session).
Title
Satisfaction Questionnaire
Description
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.
Time Frame
Participants are assessed with the Satisfaction Questionnaires at 1 time-point: posttest (one week to two after the last session).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child: 1) have a mother and/or father with subclinical or clinical symptoms of BPD; 2); present internalizing and/or externalizing problems (i.e., ≥60 in the internalizing and/or externalizing scale of CBCL 6-18); and 3) be 5-12 years old. Parent(s): 1) have subclinical or clinical symptoms of BPD; 2) have a school-aged child (5-12 years of age) with internalizing and/or externalizing problems. Exclusion Criteria: Child: 1) unable to read/speak Portuguese; 2) comorbidity with a neurodevelopmental disorder (e.g., autism spectrum disorder); 3) doesn´t live partially or fully with parent with BPD; and 4) already receiving psychological counselling. Parent(s): 1) unable to read/speak Portuguese; and 2) 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soraia S Mesquita, Msc
Phone
939531855
Ext
+351
Email
id9650@alunos.uminho.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bárbara Figueiredo, PhD
Organizational Affiliation
Psychology Research Centre (CIPsi), University of Minho
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minho
City
Braga
ZIP/Postal Code
4710-057
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
University of Minho
Phone
253 601 100
Ext
+351
Email
gcii@reitoria.uminho.pt
First Name & Middle Initial & Last Name & Degree
Soraia Mesquita, Msc
First Name & Middle Initial & Last Name & Degree
Bárbara Figueiredo, PhD

12. IPD Sharing Statement

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A Mentalization-based Intervention for Children of Parent(s) With Borderline Personality Disorder

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