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NCT05290714
The Effectiveness and Change Mechanisms of Mentalization Based Therapy for Children (MBT-C)
NA trial testing Mentalization-Based Treatment for Children (MBT-C) in Mental Disorder, Child in 222 participants. Completed in 1 February 2025.
1 January 2024
Quick facts
| Lead sponsor | Istanbul Bilgi University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 222 |
| Start date | 15 March 2022 |
| Primary completion | 1 January 2024 |
| Estimated completion | 1 February 2025 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Mentalization-Based Treatment for Children (MBT-C)
- Parenting and Social Skills Group
Conditions studied
- Mental Disorder, Child — all drugs for Mental Disorder, Child →
Sponsor
Istanbul Bilgi University
Who can join
Adults 5 to 12, any sex, with Mental Disorder, Child. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05290714
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05290714 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istanbul Bilgi University
- Last refreshed: 1 May 2025
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