Child's Internalizing and Externalizing ProblemsNCT06050486
A Mentalization-based Intervention for Children of Parent(s) With Borderline Personality Disorder
A study testing Mentalization-based treatment for children (MBT-C) in people with Child's Internalizing and Externalizing Problems, run by University of Minho at 1 site in Portugal.
Trial summary
Background and study aims? Parents with borderline personality disorder (BPD) can present parenting difficulties such as expressions of hostility, low sensitivity, and overprotection. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Child's Internalizing and Externalizing Problems
- What is being tested?
- Mentalization-based treatment for children (MBT-C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 sitePortugal
- Study dates
- 11 Sep 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- have subclinical or clinical symptoms of BPD;
- have a school-aged child (5-12 years of age) with internalizing and/or externalizing problems.
Who cannot join
- 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.
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Mentalization-based treatment for children (MBT-C)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalization-based treatment for children (MBT-C)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Intervention | Experimental | Participants in Arm 1 receive a psychological intervention (MBT-C). Receives: Behavioral: Mentalization-based treatment for children (MBT-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Behavior Checklist
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.
Measured: 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 outcomes (4)
Structured Clinical Interview for DSM-IV Axis II Personality Disorders
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start11 Sep 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child's Internalizing and Externalizing ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bárbara Figueiredo, University of Minho
- Investigators
- Bárbara Figueiredo, PhD, Principal investigator, Psychology Research Centre (CIPsi), University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050486
- Sponsor's protocol ID
- CEICSH 062/2021
- Other IDs
- 2020.08588.BD
- Status last verified
- Mar 2025
- First submitted
- 15 Sep 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mentalization-based Treatment for Children (MBT-C) of Parent(s) With Borderline Personality Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT06050486
- Acronym / sponsor ID
- CEICSH 062/2021
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The interventional model is a simple one-arm study (intervention), with 3 assessment waves (pretest, posttest and follow-up).
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Intervention | Experimental | Behavioral: Mentalization-based treatment for children (MBT-C)Participants in Arm 1 receive a psychological intervention (MBT-C). |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
- have subclinical or clinical symptoms of BPD;
- have a school-aged child (5-12 years of age) with internalizing and/or externalizing problems.
Key exclusion criteria (6 listed)
- 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.
- unable to read/speak Portuguese;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentalization-based treatment for children (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. | Behavioural | Arm 1: Intervention |
Primary outcome
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.
4 secondary outcomes
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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bárbara Figueiredo, PhD principal investigator
Psychology Research Centre (CIPsi), University of Minho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentalization-based treatment for children (MBT-C) in people with Child's Internalizing and Externalizing Problems, run by University of Minho at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.