Mental Disorder, ChildNCT05290714
The Effectiveness and Change Mechanisms of Mentalization Based Therapy for Children (MBT-C)
A study testing Mentalization-Based Treatment for Children (MBT-C) and Parenting and Social Skills Group in people with Mental Disorder, Child, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
The main aim of the project is to investigate the effectiveness and change mechanisms of Mentalization Based Therapy for Children (MBT-C; Midgley et al., 2017). MBT-C is a transdiagnostic treatment for children aged between 5 to 12 years old with the main aim of increasing mentalization and restoring epistemic trust. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Mental Disorder, Child
- What is being tested?
- Mentalization-Based Treatment for Children (MBT-C) and Parenting and Social Skills Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Child age 5 to 12 years old
- Clinical levels of child internalizing, externalizing and comorbid internalizing/externalizing problems (clinical levels on CBCL)
Who cannot join
- a clinical diagnosis of autistic spectrum disorders (ASD) (meets KSADS-PL threshold criteria)
- severe intellectual impairment (below 5th percentile on KBIT-2)
- a clinical diagnosis of psychosis (meets KSADS-PL threshold criteria)
- severe conduct disorder (clinical range on CBCL DSM-Oriented Conduct Problems scale)
- severe substance abuse and dependence (meets KSADS-PL threshold criteria)
- acute risk of harm to self and others (KSADS-PL risk item scores = 3)
Show all 13Show fewer
- an emergency/crisis referral, where an immediate response to a significant risk is required
- Parents
- risk of psychotism (clinical on BSI psychotism scale)
- severe intellectual impairment (below 5th percentile on KBIT-2)
- severe substance abuse and dependence (positive case on BAPIRIT)
- acute risk of harm to self and others (BSI item 9, 39 \& 40 = 4)
- an emergency/crisis referral, where an immediate response to a significant risk is required
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Bilgi University Psychological Counseling Center
Istanbul, Istanbul, 34060
About this study
The main aim of the project is to investigate the effectiveness and change mechanisms of Mentalization Based Therapy for Children (MBT-C; Midgley et al., 2017). MBT-C is a transdiagnostic treatment for children aged between 5 to 12 years old with the main aim of increasing mentalization and restoring epistemic trust. Parallel parental work takes place to increase parental mentalization. This project will test the effectiveness of MBT-C in a parallel group single blind pragmatic Randomized Controlled Trial (pRCT) conducted in Turkey in comparison to a parenting and social skills group. The sample will include 240 children between 5-12 years old with internalizing and externalizing and comorbid internalizing/externalizing problems and their parents. During the study, the patients will be randomized to two arms, and the treatment's effectiveness will be investigated both at short (8th and 12th weeks) and long terms (24th and 36th week) to also assess relapse prevention. Thelarge sample size and the longitudinal evaluation of primary (decrease in problems), and secondary outcomes will enable the investigation of mediators and moderators.
This project will also undertake a rigorous psychotherapy process study within the RCT, examining for the first time, for which children and under what circumstances MBT-C may be most effective, meaningfully linking process with outcome. For this purpose, patients' baseline characteristics, especially attachment security and mentalization deficits that may interact with treatment outcome (moderators) and different dimensions of mentalization that develop over the course of the treatment (change mechanisms/mediators) will be assessed.
- Conditions
- Mental Disorder, Child
- Being tested
- Mentalization-Based Treatment for Children (MBT-C), Parenting and Social Skills Group
- Keywords
- mentalization, internalizing problems, externalizing problems, comorbid internalizing/externalizing problems
- Medical subject headings
- Neurodevelopmental Disorders
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 will involve 12 paralel individual sessions with the parents and children separately conducted by two different therapists.
Parenting and Social Skills GroupBehavioural
Parenting/social skills groups will be co-led by two therapists and involve 12 group therapy sessions with the parents and their children separately (10 parents and children per group).
| Study group | Role | What they receive |
|---|---|---|
| Mentalization Based Treatment for Children (MBT-C) | Experimental | Mentalization Based Therapy for Children (MBT-C) is a transdiagnostic time-limited (12 weekly sessions) and manualized treatment for children aged between 5 to 12 years old with the main aim of increasing mentalization and restoring epistemic trust. Parallel parental work takes place to increase parental mentalization. Receives: Behavioral: Mentalization-Based Treatment for Children (MBT-C) |
| Parenting and Social Skills Group | Active comparator | Parenting groups will run for 12 weeks with 10 parents per group. They will involve activities to help parents develop effective parenting skills via working on a family genogram, providing information on child development, developing acceptance and empathy, setting boundaries and anger regulation.
The social skills groups will run for 12 weeks and will be conducted with 10 children per group. They will involve activities on self-presentation, peer communication, play skills, empathy and anger management. Receives: Behavioral: Parenting and Social Skills Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 36th week on the Child Behavior Checklist (CBCL)
The Child Behavior Checklist (CBCL; Achenbach, 1991) is a widely used method of identifying problematic behaviors in children with two separate versions for ages 1.5-5 and 6-18. The CBCL asks the parents to indicate how true a series of 112 problem behavior items are for their child in the past two months on a 3-point likert scale (0 = "not true", 1= "sometimes true", and 2 = "very true or often true"). Outcomes can be determined for significant problems for Internalizing (e.g., depression, anxiety), Externalizing (e.g., aggression, violence) or Total Problems. The scale has been adapted to Turkish with good reliability and validity (Erol et al., 1995).
Measured: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Secondary outcomes (6)
Change from Baseline to 36th week on the Me and My Feelings Questionnaire (M&MF)
Me and My Feelings Questionnaire (M\&MF; Deighton et al., 2013) is a child-report measure consisting of total short 16-items: 10-items of emotional difficulties scale and 6-items of behavioral difficulties scale. It is scored on a 3-point likert scale (0 = "never expressed", 1 = "sometimes expressed", 2 = "always expressed"). Total score of scales are calculated as the sum of item scores with threshold values 10 for the emotional difficulties and six for the behavioral difficulties. Higher scores of each set of difficulties indicate the probability of mental health problems. The scale has been adapted to Turkish with good reliability and validity (İlnem, 2020).
Measured: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Change from Baseline to 36th week on the Emotion Regulation Checklist (ERC)
Emotion Regulation Checklist (ERC; Shields \& Cicchetti, 1997) is a parent-report measure of children's emotion regulation characteristics and involves 24-items rated on a 5-point likert scale (1 = "never" to 5 = "always"). It taps into two factors one of which is emotional lability and negativity defined as arousal, anger dysregulation, and mood changes; and the second is emotion regulation defined as socially appropriate emotional displays, empathy, and emotional selfawareness. The scale has been adapted to Turkish with good reliability and validity (Batum \& Yagmurlu, 2007).
Measured: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Change from Baseline to 12th week on the Children's Global Assessment Scale (CGAS)
The Children's Global Assessment Scale (CGAS; Schaffer et al., 1983) is a numeric scale (from 1 to 100) used by mental health clinicians to rate the global functioning of children under the age of 18 on a scale of 0 to 100. 90-81 range is scored when there is "good functioning in all areas; security in family, school, and with peers with only transient difficulties and everyday worries"; 50-41, when there is "moderate degree of interference in functioning in most social areas or severe impairment of functioning in one area"; and 20-11, when there is "need for considerable supervision to prevent hurting others or self or to maintain personal hygiene or gross impairment in all forms of communication". The scale has been adapted to Turkish with good reliability and validity (Gökler et al., 2004).
Measured: Baseline (T0), 8th week (T1), 12th week (T2)
Change from Baseline to 36th week on the Parental Stress Index - Short Form (PSI-SF)
Parental Stress Index - Short Form (PSI-SF; Abidin, 1983) is a 36-item parent-report scale.The PSI-SF contains 36 items divided into three subscales, each composed of 12 items: "Parental distress"; "Parent-child dysfunctional interaction"; "Difficult child". Each item is rated on a 5-point likert scale from 1 = "strongly disagree" to 5 = strongly agree". The PSI-SF gives three subscores and a total distress score. The scale has been adapted to Turkish with good reliability and validity (Mert et al., 2008).
Measured: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Change from Baseline to 36th week on the Parent Reflective Functioning Questionnaire (PRF-Q)
Parental Reflective Functioning Questionnaire (PRFQ; Luyten et al. 2017) includes 18 items divided into three subscales that measure PRF. A 7-point likert scale from 1 (strongly disagree) to 7 (strongly agree) is used to score each item. The PRFQ gives three subscales pertaining to "curiosity and interest in mental states", "prementalizing modes" and "certainty about mental states". The scale is in the process of being adapted to Turkish by our research group.
Measured: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Change from Baseline to 36th week on the Difficulties in Emotion Regulation Scale (DERS)
Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004) is an instrument measuring emotion regulation problems in adults (to be used with parents in the current study). The scale comprises 36 items that are rated on a 5-point likert scale from 1 = "almost never" to 5 = "almost always", with higher scores indicating a difficulty of emotion regulation. The scale produces scores on the following subscales: (a) lack of awareness of emotional responses; (b) lack of clarity of emotional responses; (c) nonacceptance of emotional responses; (d) limited access to effective strategies; (e) difficulties in controlling impulsive behavior when experiencing negative affect; and (f) difficulties in engaging goal directed behavior when experiencing negative affect as well as a total disregulation score. The scale has been adapted to Turkish with good reliability and validity (Yiğit \& Güzey-Yiğit, 2017).
Measured: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start15 Mar 2022
- Primary completion1 Jan 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Disorder, ChildStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Anna Freud National Centre for Children and Families
- Responsible party
- Principal investigator, Sibel Halfon, Istanbul Bilgi University
- Investigators
- SİBEL HALFON, PhD, Principal investigator, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290714
- Sponsor's protocol ID
- MBT-C Trial
- Status last verified
- Apr 2025
- First submitted
- 26 Feb 2022
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of the primary objective, published data might be provided to interested scientists on request for meta-analyses or secondary analyses of variables of interest in an anonymized way, with permission from the trial team.
Publications
Midgley, N., Ensink, K., Lindqvist, K., Malberg, N., & Muller, N. (2017). Mentalization-based treatment for children: A time-limited approach. American Psychological Association. https://doi.org/10.1037/0000028-000
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Change Mechanisms of Mentalization Based Therapy for Children (MBT-C)
- ClinicalTrials.gov ID
- NCT05290714
- Acronym / sponsor ID
- MBT-C Trial
- Conditions
- Mental Disorder, Child
- Keywords
- mentalization, internalizing problems, externalizing problems, comorbid internalizing/externalizing problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Anna Freud National Centre for Children and Families
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 22 Mar 2022 (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.
The main aim of the project is to investigate the effectiveness and change mechanisms of Mentalization Based Therapy for Children (MBT-C; Midgley et al., 2017). MBT-C is a transdiagnostic treatment for children aged between 5 to 12 years old with the main aim of increasing mentalization and restoring epistemic trust. Parallel parental work takes place to increase parental mentalization. This project will test the effectiveness of MBT-C in a parallel group single blind pragmatic Randomized Controlled Trial (pRCT) conducted in Turkey in comparison to a parenting and social skills group. The sample will include 240 children between 5-12 years old with internalizing and externalizing and comorbid internalizing/externalizing problems and their parents. During the study, the patients will be randomized to two arms, and the treatment's effectiveness will be investigated both at short (8th and 12th weeks) and long terms (24th and 36th week) to also assess relapse prevention. Thelarge sample size and the longitudinal evaluation of primary (decrease in problems), and secondary outcomes will enable the investigation of mediators and moderators.
This project will also undertake a rigorous psychotherapy process study within the RCT, examining for the first time, for which children and under what circumstances MBT-C may be most effective, meaningfully linking process with outcome. For this purpose, patients' baseline characteristics, especially attachment security and mentalization deficits that may interact with treatment outcome (moderators) and different dimensions of mentalization that develop over the course of the treatment (change mechanisms/mediators) will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentalization Based Treatment for Children (MBT-C) | Experimental | Behavioral: Mentalization-Based Treatment for Children (MBT-C)Mentalization Based Therapy for Children (MBT-C) is a transdiagnostic time-limited (12 weekly sessions) and manualized treatment for children aged between 5 to 12 years old with the main aim of increasing mentalization and restoring epistemic trust. Parallel parental work takes place to increase parental mentalization. |
| Parenting and Social Skills Group | Active comparator | Behavioral: Parenting and Social Skills GroupParenting groups will run for 12 weeks with 10 parents per group. They will involve activities to help parents develop effective parenting skills via working on a family genogram, providing information on child development, developing acceptance and empathy, setting boundaries and anger regulation. The social skills groups will run for 12 weeks and will be conducted with 10 children per group. They will involve activities on self-presentation, peer communication, play skills, empathy and anger management. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Child age 5 to 12 years old
- Clinical levels of child internalizing, externalizing and comorbid internalizing/externalizing problems (clinical levels on CBCL)
Key exclusion criteria (13 listed)
- a clinical diagnosis of autistic spectrum disorders (ASD) (meets KSADS-PL threshold criteria)
- severe intellectual impairment (below 5th percentile on KBIT-2)
- a clinical diagnosis of psychosis (meets KSADS-PL threshold criteria)
- severe conduct disorder (clinical range on CBCL DSM-Oriented Conduct Problems scale)
- severe substance abuse and dependence (meets KSADS-PL threshold criteria)
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 will involve 12 paralel individual sessions with the parents and children separately conducted by two different therapists. | Behavioural | Mentalization Based Treatment for Children (MBT-C) |
| Parenting and Social Skills GroupParenting/social skills groups will be co-led by two therapists and involve 12 group therapy sessions with the parents and their children separately (10 parents and children per group). | Behavioural | Parenting and Social Skills Group |
Primary outcome
Change from Baseline to 36th week on the Child Behavior Checklist (CBCL)
Time frame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
The Child Behavior Checklist (CBCL; Achenbach, 1991) is a widely used method of identifying problematic behaviors in children with two separate versions for ages 1.5-5 and 6-18. The CBCL asks the parents to indicate how true a series of 112 problem behavior items are for their child in the past two months on a 3-point likert scale (0 = "not true", 1= "sometimes true", and 2 = "very true or often true"). Outcomes can be determined for significant problems for Internalizing (e.g., depression, anxiety), Externalizing (e.g., aggression, violence) or Total Problems. The scale has been adapted to Turkish with good reliability and validity (Erol et al., 1995).
6 secondary outcomes
Change from Baseline to 36th week on the Me and My Feelings Questionnaire (M&MF)
Time frame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Change from Baseline to 36th week on the Emotion Regulation Checklist (ERC)
Time frame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Change from Baseline to 12th week on the Children's Global Assessment Scale (CGAS)
Time frame: Baseline (T0), 8th week (T1), 12th week (T2)
Change from Baseline to 36th week on the Parental Stress Index - Short Form (PSI-SF)
Time frame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Change from Baseline to 36th week on the Parent Reflective Functioning Questionnaire (PRF-Q)
Time frame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Change from Baseline to 36th week on the Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- BackgroundMidgley, N., Ensink, K., Lindqvist, K., Malberg, N., & Muller, N. (2017). Mentalization-based treatment for children: A time-limited approach. American Psychological Association. https://doi.org/10.1037/0000028-000
- Individual participant dataSharing planned: Yes. After publication of the primary objective, published data might be provided to interested scientists on request for meta-analyses or secondary analyses of variables of interest in an anonymized way, with permission from the trial team.
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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.
SİBEL HALFON, PhD principal investigator
Istanbul Bilgi University
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) and Parenting and Social Skills Group in people with Mental Disorder, Child, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
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 2 inclusion and 13 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: finished, as of the sponsor's last update on 1 May 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline to 36th week on the Child Behavior Checklist (CBCL) (time frame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05290714, which also lists 1 linked publication.
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 1 May 2025.