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

Istanbul Bilgi University

Status: Completed

Conditions: Mental Disorder, Child

Treatments: Behavioral: Parenting and Social Skills Group; Behavioral: Mentalization-Based Treatment for Children (MBT-C)

Study type: Interventional

Funder types: Other

Identifiers

NCT05290714

MBT-C Trial

Details and patient eligibility

About

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.

Enrollment: 222 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 Children

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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222 participants in 2 patient groups

Mentalization Based Treatment for Children (MBT-C)

Experimental group

Description:

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.

Treatment:

Behavioral: Mentalization-Based Treatment for Children (MBT-C)

Parenting and Social Skills Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Parenting and Social Skills Group