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

NCT ID: NCT05290714

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2025-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mentalization-Based Treatment for Children (MBT-C)

Intervention Type: BEHAVIORAL

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

Parenting and Social Skills Group

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.

Group Type: ACTIVE_COMPARATOR

Parenting and Social Skills Group

Intervention Type: 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).

Interventions

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.

Intervention Type: BEHAVIORAL

Parenting and Social Skills Group

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Child age 5 to 12 years old

2. Clinical levels of child internalizing, externalizing and comorbid internalizing/externalizing problems (clinical levels on CBCL)

Exclusion Criteria

1. a clinical diagnosis of autistic spectrum disorders (ASD) (meets KSADS-PL threshold criteria)

2. severe intellectual impairment (below 5th percentile on KBIT-2)

3. a clinical diagnosis of psychosis (meets KSADS-PL threshold criteria)

4. severe conduct disorder (clinical range on CBCL DSM-Oriented Conduct Problems scale)

5. severe substance abuse and dependence (meets KSADS-PL threshold criteria)

6. acute risk of harm to self and others (KSADS-PL risk item scores = 3)

7. an emergency/crisis referral, where an immediate response to a significant risk is required

Parents

1. risk of psychotism (clinical on BSI psychotism scale)

2. severe intellectual impairment (below 5th percentile on KBIT-2)

3. severe substance abuse and dependence (positive case on BAPIRIT)

4. acute risk of harm to self and others (BSI item 9, 39 & 40 = 4)

5. an emergency/crisis referral, where an immediate response to a significant risk is required

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Anna Freud National Centre for Children and Families

OTHER

Sponsor Role: collaborator

Istanbul Bilgi University

OTHER

Sponsor Role: lead

Responsible Party

Sibel Halfon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SİBEL HALFON, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Bilgi University

Locations

Istanbul Bilgi University Psychological Counseling Center

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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

Reference Type: BACKGROUND

Other Identifiers

MBT-C Trial

Identifier Type: -

Identifier Source: org_study_id