A Case-Series Examination of a Brief CAT-Informed Intervention (CATCH-Y) for Young People That Have Self-Injured (CATCHY)
Primary Purpose
Non-Suicidal Self Injury
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Analytic Therapy for Containing Self-Harm in Young People
Sponsored by
About this trial
This is an interventional treatment trial for Non-Suicidal Self Injury
Eligibility Criteria
Inclusion Criteria:
- Participants will be between the ages of 13 - 17 years.
- Participants will have self-injured at least once in the past six months and have a lifetime history of two or more episodes of NSSI.
- Participants will have a clinician allocated to them within CAMHS or a 3rd sector service.
- Participants will have access to the Internet.
Exclusion Criteria:
- Participants will be excluded if they are currently receiving alternative psychological therapies from a mental health professional. Participants may be receiving other forms of ongoing contact and support that do not constitute a formal psychological therapy.
- Participants will be excluded if they have a severe intellectual disability, which would impair their ability to participate without considerable adaptations being made to the intervention.
- Participants will be excluded if they have inadequate English-language speaking skills due to limitations in their ability to engage with talking therapies in the English language.
- Participants will be excluded if they are judged at high risk of harm to themselves, operationalised as having current suicidal thoughts with a high intent or active plan to end their life.
Sites / Locations
- University of Manchester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive Analytic Therapy for Containing Self-Harm in Young People
Arm Description
Brief one-to-one psychological therapy using Cognitive Analytic Therapy principles, designed for young people who self-harm
Outcomes
Primary Outcome Measures
Retention rate
Attendance at each session will be recorded to determine whether over 70 percent of participants will be retained from baseline to the end of the study.
Referral rates
Referrals will be recorded to test the hypothesis that over 50 percent of those who are referred to the study and are eligible to participate, consent to take part.
Missing data
Completion of measurements will be analysed to test whether the level of missing data exceeds 20 percent per assessment.
Acceptability
An exploration of factors that influence engagement (including what was helpful/unhelpful) will be determined in the adapted version of the client satisfaction questionnaire. Response frequencies, and qualitative comments, will be presented item by item.
Secondary Outcome Measures
Repertory Grid
Repertory grids: The repertory grid will be used to explore changes in participants' perceptions of the self, others and their experiences of NSSI. Participants will be asked to complete them prior to, and following, completion of CATCH-Y. This assessment will be completed as a structured interview, with one of the researchers talking through and explaining each step. The repertory grids will be developed following established techniques (Jankowicz, 2003). Previously repertory grids have been used with adolescents (Sewell, 2020). These measures will be used pre and post intervention.
Motivation for Youth Treatment Scale
Motivation for Youth Treatment Scale. This evaluates motivation to change and desire to find solutions to difficulties in youths and their caregivers. A psychometric evaluation of this scale conducted with young people aged 11-18 found it to be a reliable tool for assessing important dimensions of intrinsic treatment motivation (Breda & Riemer, 2012). This measure will be assessed online using select survey, pre and post intervention. The minimum score is 1, the maximum score is 40. Higher scores mean a better outcome (improved motivation).
Recovery Questionnaire
Recovery Questionnaire. Examines recovery of functionality and outlook post-treatment. An evaluation of the psychometric properties of the Recovery Questionnaire with 65 young people showed good internal consistency and test-retest reliability (Bentley, Bucci & Hartley, 2019). This measure will be assessed online using select survey, pre and post intervention. The minimum score is 0, the maximum score is 93. Higher scores mean a better outcome (improved recovery).
Alexian Brothers Urges to Self-injure scale (ABUSI)
Alexian Brothers Urges to Self-injure scale (ABUSI): A measure to assess the frequency, intensity and duration of the urge to self-injure. The ABUSI has shown good internal consistency and reliability (Chavez-Flores et al., 2019). In addition, a recent study found that the ABUSI provided valid information in a population of students who self-injured (Dimitrova, Radkova, Stoyanov & Petrov, 2020). This measure will be assessed online using select survey, pre, post and weekly during the intervention. It will also be assessed for four weeks post-intervention. Summed scores range from 0 to 30 with higher scores indicating greater urges (poorer outcome).
Patient Health Questionnaire for Adolescents (PHQ-9A)
Patient Health Questionnaire for Adolescents (PHQ-9A): Low mood clinical evaluation. An examination of the PHQ-9A completed by 442 young people, showed positive validity of the measure (Richardson et al., 2010). This measure will be assessed online using select survey, pre, post and weekly during the intervention. It will also be assessed for four weeks post-intervention. Summed scores range from 0 to 27 with higher scores indicating lower mood (poorer outcome).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04708262
Brief Title
A Case-Series Examination of a Brief CAT-Informed Intervention (CATCH-Y) for Young People That Have Self-Injured
Acronym
CATCHY
Official Title
A Case-Series Examination of a Brief CAT-Informed Intervention (CATCH-Y) for Young People That Have Self-Injured
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
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
Non-suicidal self-injury (NSSI), the term used for when somebody purposefully hurts themselves without intending to end their life. Often, it suggests that there are other difficulties going on in someone's life. Talking therapies can be offered to help however currently there is little evidence to show which therapies help most. CATCH-Y (Cognitive Analytic Therapy for Containing Self-Harm in Young People) is a brief talking therapy which has been created to support young people who self-injure. It aims to help young people and those around them build to a shared understanding of their difficulties. Previously a group of adults, who have a history of self-harm, have engaged in a trial version of CATCH-Y for adults, in which it was found to be positive, safe and feasible.
The study will aim to recruit nine young people who have self-injured in the past. Participants must be aged between 13 - 17 years old and have self-injured within the last six months. They will be recruited from local Child and Adolescent Mental Health Services (CAMHS) and associated 3rd sector organisations. The therapy is five sessions long, with two assessment sessions before the therapy begins and one assessment session post-therapy. Online assessments will be completed throughout. CATCH-Y involves working with the therapist to understand a young person's past and current experiences, linked to their self-injurious behaviours. This individualised approach could benefit these young people.
As a novel treatment, and in accordance with the medical research council (MRC) framework, the feasibility and acceptability of CATCH-Y should be considered before progressing to a larger trial. This trial will examine the feasibility and acceptability of the CATCH-Y intervention through attendance and retention rates, data completion and intervention acceptability. As a secondary measure, the trial will investigate whether CATCH-Y shows preliminary evidence for positive change.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Suicidal Self Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group case series design
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Analytic Therapy for Containing Self-Harm in Young People
Arm Type
Experimental
Arm Description
Brief one-to-one psychological therapy using Cognitive Analytic Therapy principles, designed for young people who self-harm
Intervention Type
Other
Intervention Name(s)
Cognitive Analytic Therapy for Containing Self-Harm in Young People
Intervention Description
The intervention will run over five sessions, each lasting around 30 - 40 minutes. Researchers will follow the CATCH-Y manualised treatment guide. CATCH-Y is a brief, five session psychological intervention based upon CAT principles and designed to help young people who have self-injured.
Primary Outcome Measure Information:
Title
Retention rate
Description
Attendance at each session will be recorded to determine whether over 70 percent of participants will be retained from baseline to the end of the study.
Time Frame
seven weeks
Title
Referral rates
Description
Referrals will be recorded to test the hypothesis that over 50 percent of those who are referred to the study and are eligible to participate, consent to take part.
Time Frame
Completion of study, approximately 18 months
Title
Missing data
Description
Completion of measurements will be analysed to test whether the level of missing data exceeds 20 percent per assessment.
Time Frame
Completion of study, approximately 18 months
Title
Acceptability
Description
An exploration of factors that influence engagement (including what was helpful/unhelpful) will be determined in the adapted version of the client satisfaction questionnaire. Response frequencies, and qualitative comments, will be presented item by item.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Repertory Grid
Description
Repertory grids: The repertory grid will be used to explore changes in participants' perceptions of the self, others and their experiences of NSSI. Participants will be asked to complete them prior to, and following, completion of CATCH-Y. This assessment will be completed as a structured interview, with one of the researchers talking through and explaining each step. The repertory grids will be developed following established techniques (Jankowicz, 2003). Previously repertory grids have been used with adolescents (Sewell, 2020). These measures will be used pre and post intervention.
Time Frame
up to 12 weeks
Title
Motivation for Youth Treatment Scale
Description
Motivation for Youth Treatment Scale. This evaluates motivation to change and desire to find solutions to difficulties in youths and their caregivers. A psychometric evaluation of this scale conducted with young people aged 11-18 found it to be a reliable tool for assessing important dimensions of intrinsic treatment motivation (Breda & Riemer, 2012). This measure will be assessed online using select survey, pre and post intervention. The minimum score is 1, the maximum score is 40. Higher scores mean a better outcome (improved motivation).
Time Frame
up to 12 weeks
Title
Recovery Questionnaire
Description
Recovery Questionnaire. Examines recovery of functionality and outlook post-treatment. An evaluation of the psychometric properties of the Recovery Questionnaire with 65 young people showed good internal consistency and test-retest reliability (Bentley, Bucci & Hartley, 2019). This measure will be assessed online using select survey, pre and post intervention. The minimum score is 0, the maximum score is 93. Higher scores mean a better outcome (improved recovery).
Time Frame
up to 12 weeks
Title
Alexian Brothers Urges to Self-injure scale (ABUSI)
Description
Alexian Brothers Urges to Self-injure scale (ABUSI): A measure to assess the frequency, intensity and duration of the urge to self-injure. The ABUSI has shown good internal consistency and reliability (Chavez-Flores et al., 2019). In addition, a recent study found that the ABUSI provided valid information in a population of students who self-injured (Dimitrova, Radkova, Stoyanov & Petrov, 2020). This measure will be assessed online using select survey, pre, post and weekly during the intervention. It will also be assessed for four weeks post-intervention. Summed scores range from 0 to 30 with higher scores indicating greater urges (poorer outcome).
Time Frame
up to 12 weeks
Title
Patient Health Questionnaire for Adolescents (PHQ-9A)
Description
Patient Health Questionnaire for Adolescents (PHQ-9A): Low mood clinical evaluation. An examination of the PHQ-9A completed by 442 young people, showed positive validity of the measure (Richardson et al., 2010). This measure will be assessed online using select survey, pre, post and weekly during the intervention. It will also be assessed for four weeks post-intervention. Summed scores range from 0 to 27 with higher scores indicating lower mood (poorer outcome).
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants will be between the ages of 13 - 17 years.
Participants will have self-injured at least once in the past six months and have a lifetime history of two or more episodes of NSSI.
Participants will have a clinician allocated to them within CAMHS or a 3rd sector service.
Participants will have access to the Internet.
Exclusion Criteria:
Participants will be excluded if they are currently receiving alternative psychological therapies from a mental health professional. Participants may be receiving other forms of ongoing contact and support that do not constitute a formal psychological therapy.
Participants will be excluded if they have a severe intellectual disability, which would impair their ability to participate without considerable adaptations being made to the intervention.
Participants will be excluded if they have inadequate English-language speaking skills due to limitations in their ability to engage with talking therapies in the English language.
Participants will be excluded if they are judged at high risk of harm to themselves, operationalised as having current suicidal thoughts with a high intent or active plan to end their life.
Facility Information:
Facility Name
University of Manchester
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Given small scale of the study there are no plans to make the data available to other researchers
Learn more about this trial
A Case-Series Examination of a Brief CAT-Informed Intervention (CATCH-Y) for Young People That Have Self-Injured
We'll reach out to this number within 24 hrs