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Metacognitive Therapy for Common Mental Health Problems in Autistic CYP: A Case Series

Primary Purpose

Anxiety, Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Metacognitive Therapy
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety symptoms, Depression symptoms, Metacognitive therapy, Children and young people, Autism

Eligibility Criteria

11 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 11-16 years Consent given Formal diagnosis of Autism Spectrum Disorder Fluent in English Seeking treatment for emotional disorder symptoms (i.e., generalised anxiety disorder, panic disorder, agoraphobia, post-traumatic stress disorder, obsessive compulsive disorder, social anxiety; and/or depression) Medication for mental health problems permitted but participants must be stabilised for 6 weeks Exclusion Criteria: Presence of significant risk or safeguarding concerns Head injury/organic impairment Attention Deficit Hyperactivity Disorder (formal diagnosis or under assessment) Eating Disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Metacognitive Therapy

    Arm Description

    MCT will be delivered in accordance with the MCT-PATHWAY treatment manual.

    Outcomes

    Primary Outcome Measures

    Change in The Revised Children's Anxiety and Depression Scale (RCADS-47) Score
    A 47-item screening measure designed to assess selected anxiety and depressive disorders in CYP aged 8-18. Social phobia (9 items; maximum score = 27). Panic disorder (9 items; maximum score = 27). Separation anxiety (7 items; maximum score = 21). Generalised anxiety (6 items; maximum score = 18). Obsessive-compulsive (6 items; maximum score = 18). Major depression (10 items; maximum score = 30). In response to each item, participants must select the appropriate response from 'Always' (score = 3), 'Often' (score = 2), 'Sometimes' (score = 1), 'Never' (score = 0). Total minimum score = 0. Total maximum score = 141. Higher scores indicate worse outcomes.
    Measure of Credibility and Expectancy
    A 3 item measure developed by the researchers measuring expectancy and credibility on a 10 point scale
    Measure of Adherence and User Friendliness
    A 5 item measure developed by the researchers to measure adherence and user friendliness on a 10 point scale
    Post Intervention Interview
    A semi structured interview focusing on perceived benefits and challenges of the therapy, as well as specific aspects of the therapy such as the outcome measures or intervention techniques.

    Secondary Outcome Measures

    Change in The Youth Cognitive Attentional Syndrome-1 (YoCAS-1-1) Score
    A 7 item self-report measure to assess metacognitive skills and knowledge in youth, including worry/rumination, threat monitoring, coping behaviours and metacognitive beliefs.
    Change in Metacognitions Questionnaire - Adolescent version (MCQ-A) Score
    A 30-item scale designed to measure metacognitive beliefs in adolescents.
    Change in Child Health Utility -9D (CHU-9D) Score
    A 9 item self-report questionnaire to assess health related quality of life in 7-17-year-olds.
    Change in Personal Rating Scale Score
    A personal rating scale developed by the researchers, to be administered weekly measuring how distressing the problem has been and how much the problem has interfered with day to day life

    Full Information

    First Posted
    May 9, 2023
    Last Updated
    August 4, 2023
    Sponsor
    University of Manchester
    Collaborators
    Manchester University NHS Foundation Trust, Pennine Care NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05980143
    Brief Title
    Metacognitive Therapy for Common Mental Health Problems in Autistic CYP: A Case Series
    Official Title
    Can Metacognitive Therapy be Used to Treat Common Mental Health Problems in Autistic Children and Adolescents: A Systematic Case Series
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Manchester
    Collaborators
    Manchester University NHS Foundation Trust, Pennine Care NHS Foundation Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Anxiety and Depression are common in young people (CYP) and especially in CYP with a diagnosis of Autism. Autistic people often say therapy has not been adapted to meet their needs. A recent treatment called metacognitive therapy (MCT) is proving to be helpful, but the investigators do not know how autistic CYP will find MCT, or what changes to the delivery of therapy may be needed to meet their needs. This study hopes to explore whether MCT can help treat anxiety and/or depression in autistic young people. This study aims to offer five autistic CYP MCT. To take part, they must be between 11-16 years old and have depression and/or anxiety symptoms. The study will involve completing questionnaires at the start, during therapy, at the end and after 6 months. Therapy will be scheduled for at least eight sessions. Therapy involves working on what we think about our worry, rather than on specific worries. What we think about our worry can be positive or negative. For example, 'worrying helps me cope' and 'worrying could make me go mad'. This can affect where our attention goes and how we think. At the end of therapy, participants will be asked to take part in an interview about how they found the therapy. The questionnaires will help test how useful the measures are, suggest how helpful the therapy might be and whether benefits continue after the therapy has ended. Information will also be gathered through a post treatment interview about how the young people found the therapy. This will help understand whether any changes to the therapy are needed to meet the needs of autistic people. This information is necessary for planning a large-scale trial for autistic CYP. Such studies may improve treatment options and service provision for mental health problems in this population. Primary Question: • Is MCT a feasible and acceptable treatment for treating anxiety and depression in autistic CYP? Secondary Questions: Is MCT associated with clinically significant change in outcome measures following the introduction of treatment for autistic CYP? Are improvements associated with MCT maintained at 6 month follow up? Are improvements associated with MCT replicable across autistic CYP? Do the investigators need to modify how MCT is delivered to autistic CYP?
    Detailed Description
    This study is a systematic replication case series utilising an AB design with follow up to deliver MCT to autistic CYP who experience symptoms of anxiety and/or depression. Allocation to baseline lengths will not be randomised, natural baselines will be utilised whereby participants complete the primary outcome measure weekly until they demonstrate stability. Stability will be defined as an absence of decreasing trend of at least three consecutive data points prior to the introduction of treatment. Recruitment: Participants will be identified by CAMHS clinicians during routine clinical practice. Potential participants will be provided with information about the study, including the participant information sheet. Those who are identified as eligible and are interested in taking part or finding out more about the study will consent to their details being shared with the researcher. The details will be securely sent to the researcher using the eligibility form. The researcher will then contact potential participants to confirm whether the like to participate and answer any questions they have about the study. Screening: Those who wish to participate will then be invited to attend a screening appointment with the researcher. Written consent will be obtained from participants (and parents/guardians where appropriate). Once consent has been obtained, demographic information, baseline measures will be administered. Baseline During the baseline phase, participants will be asked to complete baseline measures once a week for a minimum of 3 weeks, until stability is achieved. Intervention: Participants will be offered a minimum of eight weekly sessions of MCT at their local CAMHS. Each session will last approximately an hour. This will be applied flexibly, and sessions can be extended in response to client progress. This will provide information about whether the investigators need to modify the delivery of MCT to autistic CYP. Participants will be asked to complete sessional measures. Post Intervention interview: Participants will be asked to take part in the post intervention interview to gather information about how they found the intervention. This will consider factors such as components of the intervention that were well received, and those which were less well received. Follow up: Participants will be asked to complete follow up measures 6 months after the final treatment session.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Depression
    Keywords
    Anxiety symptoms, Depression symptoms, Metacognitive therapy, Children and young people, Autism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Metacognitive Therapy
    Arm Type
    Experimental
    Arm Description
    MCT will be delivered in accordance with the MCT-PATHWAY treatment manual.
    Intervention Type
    Other
    Intervention Name(s)
    Metacognitive Therapy
    Intervention Description
    The transdiagnostic Metacognitive model suggests that psychological difficulties arise from the activation of a thinking style called the CAS (Cognitive Attentional Syndrome). Metacognitive Therapy (MCT) aims to bring the CAS under control. The therapist helps the patient to learn new ways of relating to stressful thoughts.
    Primary Outcome Measure Information:
    Title
    Change in The Revised Children's Anxiety and Depression Scale (RCADS-47) Score
    Description
    A 47-item screening measure designed to assess selected anxiety and depressive disorders in CYP aged 8-18. Social phobia (9 items; maximum score = 27). Panic disorder (9 items; maximum score = 27). Separation anxiety (7 items; maximum score = 21). Generalised anxiety (6 items; maximum score = 18). Obsessive-compulsive (6 items; maximum score = 18). Major depression (10 items; maximum score = 30). In response to each item, participants must select the appropriate response from 'Always' (score = 3), 'Often' (score = 2), 'Sometimes' (score = 1), 'Never' (score = 0). Total minimum score = 0. Total maximum score = 141. Higher scores indicate worse outcomes.
    Time Frame
    Baseline period: baseline time one to 4-6 weeks post baseline one; end of treatment:12-16 weeks post-baseline one; and 6 month follow up.
    Title
    Measure of Credibility and Expectancy
    Description
    A 3 item measure developed by the researchers measuring expectancy and credibility on a 10 point scale
    Time Frame
    Intervention session 1 (4-6 weeks after 1st baseline measure, dependant on length of baseline)
    Title
    Measure of Adherence and User Friendliness
    Description
    A 5 item measure developed by the researchers to measure adherence and user friendliness on a 10 point scale
    Time Frame
    Final intervention session (12-16 weeks post baseline dependent on whether sessions are extended in response to participant needs)
    Title
    Post Intervention Interview
    Description
    A semi structured interview focusing on perceived benefits and challenges of the therapy, as well as specific aspects of the therapy such as the outcome measures or intervention techniques.
    Time Frame
    12-16 weeks post baseline (dependent on whether sessions are extended in response to participant needs)
    Secondary Outcome Measure Information:
    Title
    Change in The Youth Cognitive Attentional Syndrome-1 (YoCAS-1-1) Score
    Description
    A 7 item self-report measure to assess metacognitive skills and knowledge in youth, including worry/rumination, threat monitoring, coping behaviours and metacognitive beliefs.
    Time Frame
    Weekly during baseline and intervention (across 12-16 weeks dependant on length of baseline and intervention) and at 6 months follow up)
    Title
    Change in Metacognitions Questionnaire - Adolescent version (MCQ-A) Score
    Description
    A 30-item scale designed to measure metacognitive beliefs in adolescents.
    Time Frame
    Baseline period: baseline time one and at 4-6 weeks post baseline one; end of treatment: at 12-16 weeks post-baseline one; and 6 month follow up.
    Title
    Change in Child Health Utility -9D (CHU-9D) Score
    Description
    A 9 item self-report questionnaire to assess health related quality of life in 7-17-year-olds.
    Time Frame
    Baseline period: baseline time one and at 4-6 weeks post baseline one; end of treatment: at 12-16 weeks post-baseline one; and 6 month follow up.
    Title
    Change in Personal Rating Scale Score
    Description
    A personal rating scale developed by the researchers, to be administered weekly measuring how distressing the problem has been and how much the problem has interfered with day to day life
    Time Frame
    Weekly during baseline and intervention (across 12-16 weeks dependant on length of baseline and intervention) and at 6 months follow up)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 11-16 years Consent given Formal diagnosis of Autism Spectrum Disorder Fluent in English Seeking treatment for emotional disorder symptoms (i.e., generalised anxiety disorder, panic disorder, agoraphobia, post-traumatic stress disorder, obsessive compulsive disorder, social anxiety; and/or depression) Medication for mental health problems permitted but participants must be stabilised for 6 weeks Exclusion Criteria: Presence of significant risk or safeguarding concerns Head injury/organic impairment Attention Deficit Hyperactivity Disorder (formal diagnosis or under assessment) Eating Disorder

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22329531
    Citation
    Ebesutani C, Reise SP, Chorpita BF, Ale C, Regan J, Young J, Higa-McMillan C, Weisz JR. The Revised Child Anxiety and Depression Scale-Short Version: scale reduction via exploratory bifactor modeling of the broad anxiety factor. Psychol Assess. 2012 Dec;24(4):833-45. doi: 10.1037/a0027283. Epub 2012 Feb 13.
    Results Reference
    background
    PubMed Identifier
    15125986
    Citation
    Cartwright-Hatton S, Mather A, Illingworth V, Brocki J, Harrington R, Wells A. Development and preliminary validation of the Meta-cognitions Questionnaire-Adolescent Version. J Anxiety Disord. 2004;18(3):411-22. doi: 10.1016/S0887-6185(02)00294-3.
    Results Reference
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    PubMed Identifier
    22788262
    Citation
    Stevens K. Valuation of the Child Health Utility 9D Index. Pharmacoeconomics. 2012 Aug 1;30(8):729-47. doi: 10.2165/11599120-000000000-00000.
    Results Reference
    background
    Citation
    Wells, A. (2009). Metacognitive Therapy for Anxiety and Depression. New York: Guilford Press
    Results Reference
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    PubMed Identifier
    8990539
    Citation
    Wells A, Matthews G. Modelling cognition in emotional disorder: the S-REF model. Behav Res Ther. 1996 Nov-Dec;34(11-12):881-8. doi: 10.1016/s0005-7967(96)00050-2.
    Results Reference
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    PubMed Identifier
    31920769
    Citation
    Wells A. Breaking the Cybernetic Code: Understanding and Treating the Human Metacognitive Control System to Enhance Mental Health. Front Psychol. 2019 Dec 12;10:2621. doi: 10.3389/fpsyg.2019.02621. eCollection 2019.
    Results Reference
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    PubMed Identifier
    18645422
    Citation
    Simonoff E, Pickles A, Charman T, Chandler S, Loucas T, Baird G. Psychiatric disorders in children with autism spectrum disorders: prevalence, comorbidity, and associated factors in a population-derived sample. J Am Acad Child Adolesc Psychiatry. 2008 Aug;47(8):921-9. doi: 10.1097/CHI.0b013e318179964f.
    Results Reference
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    PubMed Identifier
    30487770
    Citation
    Normann N, Morina N. The Efficacy of Metacognitive Therapy: A Systematic Review and Meta-Analysis. Front Psychol. 2018 Nov 14;9:2211. doi: 10.3389/fpsyg.2018.02211. eCollection 2018.
    Results Reference
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    PubMed Identifier
    30245739
    Citation
    Cooper K, Loades ME, Russell AJ. Adapting Psychological Therapies for Autism - Therapist Experience, Skills and Confidence. Res Autism Spectr Disord. 2018 Jan 1;45:43-50. doi: 10.1016/j.rasd.2017.11.002.
    Results Reference
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    Citation
    Barlow, D. H., Nock, M., & Hersen, M. (2008). Single case research designs: Strategies for studying behaviour change.
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    Metacognitive Therapy for Common Mental Health Problems in Autistic CYP: A Case Series

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