Clinical trial NCT05980143: 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
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Keywords: Anxiety symptoms
Depression symptoms
Metacognitive therapy
Children and young people
Autism
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
name: Pennine Care NHS Foundation Trust
First posted: 2023-08-07
Enrollment: 5
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 the Personal Rating Scale and the YoCas-1 once a week for a minimum of 3 weeks, until stability is achieved. Only the Personal Rating Scale will be used to measure stability. Stability is defined as the absence of a decreasing trend on three consecutive data points prior to the introduction of treatment. All other outcome measures will be completed at the end of the baseline phase prior to starting treatment.

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.

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

Primary outcomes:
measure: Change in The Revised Children's Anxiety and Depression Scale (RCADS-25) Score
timeFrame: 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: Measure of Credibility and Expectancy
timeFrame: Intervention session 1 (3-6 weeks after 1st baseline measure, dependant on length of baseline)
measure: Measure of Adherence and User Friendliness
timeFrame: Final intervention session (12-16 weeks post baseline dependent on whether sessions are extended in response to participant needs)
measure: Post Intervention Interview
timeFrame: 12-16 weeks post baseline (dependent on whether sessions are extended in response to participant needs)
measure: Change in Personal Rating Scale Score
timeFrame: Weekly during baseline and intervention (across 12-16 weeks dependant on length of baseline and intervention) and at 6 months follow up)
Secondary outcomes:
measure: Change in The Youth Cognitive Attentional Syndrome-1 (YoCAS-1) Score
timeFrame: Weekly during baseline and intervention (across 12-16 weeks dependant on length of baseline and intervention) and at 6 months follow up)
measure: Change in Metacognitions Questionnaire - Adolescent version (MCQ-A) Score
timeFrame: 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.
measure: Change in Child Health Utility -9D (CHU-9D) Score
timeFrame: 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.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Pennine Care NHS Foundation Trust
Study officials:
References:
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