Loading search results
Sponsor study identifier
interventional
222
1 country
1
Study Start
March 15, 2022
Actual (reported)Primary Completion
January 1, 2024
Actual (reported)Study Completion
February 1, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2022
Actual (reported)March 15, 2022
Actual (reported)March 22, 2022
Actual (reported)January 1, 2024
Actual (reported)February 1, 2025
Actual (reported)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).
Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Change from Baseline to 36th week on the Me and My Feelings Questionnaire (M&MF)
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)
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)
Baseline (T0), 8th week (T1), 12th week (T2)
Change from Baseline to 36th week on the Parental Stress Index - Short Form (PSI-SF)
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)
Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Screening: Brief Symptom Inventory (BSI)
Baseline (T0)
Screening: Schedule for Affective Disorders and Schizophrenia for School Aged Children (6-18 Years) (K-SADS-PL DSM-5)
Baseline (T0)
Screening: Kaufman Brief Intelligence Test-Second Edition (KBIT-2)
Baseline (T0)
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 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.
MBT-C will involve 12 paralel individual sessions with the parents and children separately conducted by two different therapists.
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).
Istanbul Bilgi University Psychological Counseling Center
Istanbul, Istanbul, 34060, Turkey (Türkiye)
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
SİBEL HALFON, PhD
Istanbul Bilgi University
222 participants (actual enrollment reported by the registry).
First Submitted
February 26, 2022
First Posted
March 22, 2022
Study Start
March 15, 2022
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 1, 2024
Actual (reported)Study Completion
February 1, 2025
Actual (reported)Last Updated
May 1, 2025
Record last verified: 2025-04
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: