Youth Metacognitive Therapy Feasibility Trial

Study Overview
=================
Brief Summary
-----------------
One in eight children and young people (CYP) suffer mental health problems needing support or treatment and 5% have more than one such problem. The effects can be major, affecting CYP emotionally and functionally, impacting progress at school, relationships with others and increasing long term risk of mental health problems. Parents, schools, policy makers and the NHS often struggle to find the best way to help, especially within their limited budgets. The UK Government and the NHS have highlighted the need to improve mental health in CYP. The most common treatment is cognitive behavioural therapy; however this can be time consuming, needs to be delivered over many weeks, must focus on the most upsetting problem first and is not very effective. One way to overcome this is to evaluate a group therapy that can treat multiple mental health problems at once. This new treatment is called Metacognitive Therapy (MCT). The aim of the study is to see if participating in a randomized trial of Group MCT is a feasible and acceptable treatment for CYP suffering with anxiety, stress, depression, or a combination in comparison to usual care. This allows us to test key questions about recruitment and drop-out rates, test the protocol, and gain information about MCT including training and supervision needs of clinicians and the experience of patients receiving it.

Official Title
-----------------
Youth Metacognitive Therapy (YoMETA): A Single-Blind Parallel Randomised Feasibility Trial

Conditions
-----------------
Child Mental Disorder, Anxiety Disorders, Depression

Intervention / Treatment
-----------------
* Behavioral: Treatment as usual: Control
* Behavioral: Group Metacognitive Therapy (Group-MCT): Experimental


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seeking treatment for emotional disorder symptoms (i.e. generalized anxiety disorder, panic disorder, agoraphobia, post-traumatic stress disorder, obsessive compulsive disorder, social anxiety and/or depression). Native fluency in English language Medication permitted but must be stabilised for 6 weeks. Exclusion Criteria: Presence of significant risk or safeguarding concerns Head injury/organic impairment Formal diagnosis or under assessment for Autism Spectrum Disorder or Attention Deficit-Hyperactivity Disorder Eating Disorder

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 16 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 |
| --- | --- |
| Active Comparator: Usual Treatment (Control)<br>Participants allocated to the control group will receive treatment as usual under the child and adolescent mental health service. | Behavioral: Treatment as usual: Control<br>* Treatment usually delivered in service that may include but is not limited to cognitive behaviour therapy, exposure, eye movement desensitisation and reprocessing , behaviour therapy, family therapy.<br>|
| Experimental: Group MCT (Intervention)<br>Participants allocated to the intervention group will receive group metacognitive therapy sessions. | Behavioral: Group Metacognitive Therapy (Group-MCT): Experimental<br>* Group metacognitive therapy (Group-MCT) focuses on developing adaptive control of worry, repetitive negative thinking and attention and modifies beliefs that maintain unhelpful thinking patterns. Treatment is 6 to 8 weekly sessions delivered by two trained mental health professionals, guided by a treatment manual, lasting approximately 90 minutes each session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revised Children Anxiety and Depression Scale - Short Version (RCADS) | Youth self-report questionnaire measuring total anxiety, total depression and total anxiety and depression. This is a feasibility study and therefore it is not primarily powered to detect a difference (change in scores). The principal aim is to test the feasibility of a study using. Here we are testing the feasibility of using the measures (RCADS), therefore the measures will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Specifically, range in scores, number of complete measures, proportion of missing data. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment effects. | Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength and Difficulties Questionnaire (SDQ) | Measure of psychological well-being across five subscales: emotion, hyperactivity, conduct, peer relations and pro-social behaviour. Feasibility of the measure will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment. | Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up | 
| Metacognition Questionnaire - Adolescent Version (MCQ-A) | Measure of metacognitive beliefs across five subscales: positive beliefs about worry, negative beliefs about uncontrollability and danger, cognitive confidence, cognitive self-consciousness and cognitive control. Feasibility of the measure will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment. | Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up | 
| Mood & Feelings Questionnaire (MFQ) | Measure of depressive symptoms in 6-17 year olds. Feasibility of the measure will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment. | Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up | 
| Child Health Utility - 9D (CHU-9D) | Measure of paediatric quality of life using dimensions: worried, sad, pain, tired, annoyed, school/homework, sleep, daily routine, ability to join in activities. Feasibility of the measure will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment. | Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up | 
| Health and Social Case Service-Use Interview (SUI) | Assessment of the child's use of primary, secondary or community-based health and social care services and how often they have used the service in the last 16 weeks or since last study assessment. | Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metacognitive Therapy, Feasibility, Anxiety, Depression, Mental health