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

Study Overview
=================
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 220 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 weeks) to also assess relapse prevention. The large 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.

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

Conditions
-----------------
Mental Disorder, Child

Intervention / Treatment
-----------------
* Behavioral: Mentalization-Based Treatment for Children (MBT-C)
* Behavioral: Parenting and Social Skills Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Child age 5 to 12 years old Clinical levels of child internalizing, externalizing and comorbid internalizing/externalizing problems (clinical levels on CBCL) Exclusion criteria Children 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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mentalization Based Treatment for Children (MBT-C)<br>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)<br>* MBT-C will involve 12 paralel individual sessions with the parents and children separately conducted by two different therapists.<br>|
| Active Comparator: Parenting and Social Skills Group<br>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<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to 36th week on the Me and My Feelings Questionnaire (M&MF) | Me and My Feelings Questionnaire (M&MF; Deighton et al., 2013) is a child-report measure consisting of total short 16-items: 10-items of emotional difficulties scale and 6-items of behavioral difficulties scale. It is scored on a 3-point likert scale (0 = never expressed, 1 = sometimes expressed, 2 = always expressed). Total score of scales are calculated as the sum of item scores with threshold values 10 for the emotional difficulties and six for the behavioral difficulties. Higher scores of each set of difficulties indicate the probability of mental health problems. The scale has been adapted to Turkish with good reliability and validity (İlnem, 2020). | 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) | Emotion Regulation Checklist (ERC; Shields & Cicchetti, 1997) is a parent-report measure of children's emotion regulation characteristics and involves 24-items rated on a 5-point likert scale (1 = never to 5 = always). It taps into two factors one of which is emotional lability and negativity defined as arousal, anger dysregulation, and mood changes; and the second is emotion regulation defined as socially appropriate emotional displays, empathy, and emotional selfawareness. The scale has been adapted to Turkish with good reliability and validity (Batum & Yagmurlu, 2007). | 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) | The Children's Global Assessment Scale (CGAS; Schaffer et al., 1983) is a numeric scale (from 1 to 100) used by mental health clinicians to rate the global functioning of children under the age of 18 on a scale of 0 to 100. 90-81 range is scored when there is good functioning in all areas; security in family, school, and with peers with only transient difficulties and everyday worries; 50-41, when there is moderate degree of interference in functioning in most social areas or severe impairment of functioning in one area; and 20-11, when there is need for considerable supervision to prevent hurting others or self or to maintain personal hygiene or gross impairment in all forms of communication. The scale has been adapted to Turkish with good reliability and validity (Gökler et al., 2004). | Baseline (T0), 8th week (T1), 12th week (T2) | 
| Change from Baseline to 36th week on the Parental Stress Index - Short Form (PSI-SF) | Parental Stress Index - Short Form (PSI-SF; Abidin, 1983) is a 36-item parent-report scale.The PSI-SF contains 36 items divided into three subscales, each composed of 12 items: Parental distress; Parent-child dysfunctional interaction; Difficult child. Each item is rated on a 5-point likert scale from 1 = strongly disagree to 5 = strongly agree. The PSI-SF gives three subscores and a total distress score. The scale has been adapted to Turkish with good reliability and validity (Mert et al., 2008). | 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) | Parental Reflective Functioning Questionnaire (PRFQ; Luyten et al. 2017) includes 18 items divided into three subscales that measure PRF. A 7-point likert scale from 1 (strongly disagree) to 7 (strongly agree) is used to score each item. The PRFQ gives three subscales pertaining to curiosity and interest in mental states, prementalizing modes and certainty about mental states. The scale is in the process of being adapted to Turkish by our research group. | Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4) | 
| Change from Baseline to 36th week on the Difficulties in Emotion Regulation Scale (DERS) | Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) is an instrument measuring emotion regulation problems in adults (to be used with parents in the current study). The scale comprises 36 items that are rated on a 5-point likert scale from 1 = almost never to 5 = almost always, with higher scores indicating a difficulty of emotion regulation. The scale produces scores on the following subscales: (a) lack of awareness of emotional responses; (b) lack of clarity of emotional responses; (c) nonacceptance of emotional responses; (d) limited access to effective strategies; (e) difficulties in controlling impulsive behavior when experiencing negative affect; and (f) difficulties in engaging goal directed behavior when experiencing negative affect as well as a total disregulation score. The scale has been adapted to Turkish with good reliability and validity (Yiğit & Güzey-Yiğit, 2017). | Baseline (T0), 8th week (T1), 12th week (T2), 24th week (T3), 36th week (T4) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mentalization, internalizing problems, externalizing problems, comorbid internalizing/externalizing problems