The Effectiveness and Change Mechanisms of Mentalization Based Therapy for Children (MBT-C)

NCT05290714 | Completed

• 1 other identifier: MBT-C Trial
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

mentalization; internalizing problems; externalizing problems; comorbid internalizing/externalizing problems

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• 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)

Other Outcomes (11)

• 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)

Study Arms (2)

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.

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.

Behavioral: Parenting and Social Skills Group

Interventions

Mentalization-Based Treatment for Children (MBT-C) BEHAVIORAL

MBT-C will involve 12 paralel individual sessions with the parents and children separately conducted by two different therapists.

Mentalization Based Treatment for Children (MBT-C)

Parenting and Social Skills Group BEHAVIORAL

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).

Parenting and Social Skills Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child age 5 to 12 years old
• Clinical levels of child internalizing, externalizing and comorbid internalizing/externalizing problems (clinical levels on CBCL)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Istanbul Bilgi University: lead
• The Scientific and Technological Research Council of Turkey: collaborator
• Anna Freud National Centre for Children and Families: collaborator

Study Sites (1)

Istanbul Bilgi University Psychological Counseling Center

Istanbul, Istanbul, 34060, Turkey (Türkiye)

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Mentalization-Based Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• SİBEL HALFON, PhD

  Istanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 22, 2022
• Study Start: March 15, 2022
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the end of the study

Locations

TU (1)