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

NCT05980143 | Recruiting

• 1 other identifier: 320925
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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?

Conditions

Anxiety; Depression

Keywords

Anxiety symptoms; Depression symptoms; Metacognitive therapy; Children and young people; Autism

Outcome Measures

Primary Outcomes (5)

• Change in The Revised Children's Anxiety and Depression Scale (RCADS-25) Score

  A 25-item screening measure designed to assess anxiety and depressive disorders in CYP aged 8-18. Anxiety (15 items; maximum score 45) and 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 = 75. Higher scores indicate worse outcomes.

  Baseline period: baseline time one to end of baseline, 4-6 weeks post baseline; end of treatment:12-16 weeks post-baseline one; and 6 month follow up.

• Measure of Credibility and Expectancy

  A 3 item measure developed by the researchers measuring expectancy and credibility on a 10 point scale

  Intervention session 1 (3-6 weeks after 1st baseline measure, dependant on length of baseline)

• 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

  Final intervention session (12-16 weeks post baseline dependent on whether sessions are extended in response to participant needs)

• 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.

  12-16 weeks post baseline (dependent on whether sessions are extended in response to participant needs)

• 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

  Weekly during baseline and intervention (across 12-16 weeks dependant on length of baseline and intervention) and at 6 months follow up)

Secondary Outcomes (3)

• Change in The Youth Cognitive Attentional Syndrome-1 (YoCAS-1) Score

  Weekly during baseline and intervention (across 12-16 weeks dependant on length of baseline and intervention) and at 6 months follow up)

• Change in Metacognitions Questionnaire - Adolescent version (MCQ-A) Score

  Baseline period: baseline time one and at end of baseline, 4-6 weeks post baseline; end of treatment: at 12-16 weeks post-baseline one; and 6 month follow up.

• Change in Child Health Utility -9D (CHU-9D) Score

  Baseline period: baseline time one and at end of baseline, 4-6 weeks post baseline; end of treatment: at 12-16 weeks post-baseline one; and 6 month follow up.

Study Arms (1)

Metacognitive Therapy

EXPERIMENTAL

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

Other: Metacognitive Therapy

Interventions

Metacognitive Therapy OTHER

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.

Metacognitive Therapy

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Presence of significant risk or safeguarding concerns
• Head injury/organic impairment
• Attention Deficit Hyperactivity Disorder (formal diagnosis or under assessment)
• Eating Disorder

Sponsors & Collaborators

• University of Manchester: lead
• Manchester University NHS Foundation Trust: collaborator
• Pennine Care NHS Foundation Trust: collaborator

Study Sites (2)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

NOT YET RECRUITING

Pennine Care NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

Related Publications (10)

• 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.

  PMID: 22329531 BACKGROUND

• 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.

  PMID: 15125986 BACKGROUND

• Stevens K. Valuation of the Child Health Utility 9D Index. Pharmacoeconomics. 2012 Aug 1;30(8):729-47. doi: 10.2165/11599120-000000000-00000.

  PMID: 22788262 BACKGROUND

• Wells, A. (2009). Metacognitive Therapy for Anxiety and Depression. New York: Guilford Press

  BACKGROUND

• 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.

  PMID: 8990539 BACKGROUND

• 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.

  PMID: 31920769 BACKGROUND

• 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.

  PMID: 18645422 BACKGROUND

• 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.

  PMID: 30487770 BACKGROUND

• 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.

  PMID: 30245739 BACKGROUND

• Barlow, D. H., Nock, M., & Hersen, M. (2008). Single case research designs: Strategies for studying behaviour change.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Autistic Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Central Study Contacts

Kathryn Wood

CONTACT

0161 529 4180; kathryn.wood-5@postgrad.manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: August 7, 2023
• Study Start: October 25, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

GB (2)