Clinical trial NCT05290714: The Effectiveness and Change Mechanisms of Mentalization Based Therapy for Children (MBT-C)
Official title: The Effectiveness and Change Mechanisms of Mentalization Based Therapy for Children (MBT-C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder, Child
Keywords: mentalization
internalizing problems
externalizing problems
comorbid internalizing/externalizing problems
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
name: Anna Freud National Centre for Children and Families
First posted: 2022-03-22
Enrollment: 222
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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

Primary outcomes:
measure: Change from Baseline to 36th week on the Child Behavior Checklist (CBCL)
timeFrame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Secondary outcomes:
measure: Change from Baseline to 36th week on the Me and My Feelings Questionnaire (M&MF)
timeFrame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
measure: Change from Baseline to 36th week on the Emotion Regulation Checklist (ERC)
timeFrame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
measure: Change from Baseline to 12th week on the Children's Global Assessment Scale (CGAS)
timeFrame: Baseline (T0), 8th week (T1), 12th week (T2)
measure: Change from Baseline to 36th week on the Parental Stress Index - Short Form (PSI-SF)
timeFrame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
measure: Change from Baseline to 36th week on the Parent Reflective Functioning Questionnaire (PRF-Q)
timeFrame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
measure: Change from Baseline to 36th week on the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4)
Other outcomes:
measure: Screening: Brief Symptom Inventory (BSI)
timeFrame: Baseline (T0)
measure: Screening: Schedule for Affective Disorders and Schizophrenia for School Aged Children (6-18 Years) (K-SADS-PL DSM-5)
timeFrame: Baseline (T0)
measure: Screening: Kaufman Brief Intelligence Test-Second Edition (KBIT-2)
timeFrame: Baseline (T0)
measure: Screening: BAPIRT Alcohol and Drug Questionnaire
timeFrame: Baseline (T0)
measure: Baseline Moderator: Adverse Childhood Experiences Scale (ACE)
timeFrame: Baseline (T0)
measure: Baseline Moderator: Attachment Doll Story Completion Task (ASCT)
timeFrame: Baseline (T0)
measure: Baseline Moderator: Kerns Security Scale (KSS)
timeFrame: Baseline (T0)
measure: Baseline Moderator: Experiences in Close Relationships Scale-II (ECR-II)
timeFrame: Baseline (T0)
measure: Baseline Moderator: The Child Attachment Interview (CAI; Target et al. 2003)
timeFrame: Baseline (T0)
measure: Experience of Service Questionnaire (ESQ)
timeFrame: 12th week (T2)
measure: Therapeutic Alliance Scale for Children-revised (TASCr-C, TASCr-T, TASCr-P)
timeFrame: 3rd week (T1) 8th week (T2) 12th week (T3)
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Bilgi University Psychological Counseling Center
state: İ̇stanbul
Study officials:
affiliation: Istanbul Bilgi University
name: SİBEL HALFON, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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