Non-Suicidal Self InjuryCATCHYNCT04708262
A Case-Series Examination of a Brief CAT-Informed Intervention (CATCH-Y) for Young People That Have Self-Injured
A study testing Cognitive Analytic Therapy for Containing Self-Harm in Young People in people with Non-Suicidal Self Injury, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Non-Suicidal Self Injury
- What is being tested?
- Cognitive Analytic Therapy for Containing Self-Harm in Young People
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Apr 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Non-Suicidal Self Injury
- Being tested
- Cognitive Analytic Therapy for Containing Self-Harm in Young People
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Analytic Therapy for Containing Self-Harm in Young PeopleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Analytic Therapy for Containing Self-Harm in Young People | Experimental | Brief one-to-one psychological therapy using Cognitive Analytic Therapy principles, designed for young people who self-harm Receives: Other: Cognitive Analytic Therapy for Containing Self-Harm in Young People |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: seven weeks
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.
Measured: Completion of study, approximately 18 months
Missing data
Completion of measurements will be analysed to test whether the level of missing data exceeds 20 percent per assessment.
Measured: Completion of study, approximately 18 months
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.
Measured: up to 12 weeks
Secondary outcomes (5)
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.
Measured: up to 12 weeks
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).
Measured: up to 12 weeks
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).
Measured: up to 12 weeks
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).
Measured: up to 12 weeks
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).
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start2 Apr 2021
- Primary completion13 Dec 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Suicidal Self InjuryStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group case series design
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Taylor, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708262
- Sponsor's protocol ID
- 287611
- Acronym
- CATCHY
- Status last verified
- May 2022
- First submitted
- 6 Jan 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given small scale of the study there are no plans to make the data available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-Series Examination of a Brief CAT-Informed Intervention (CATCH-Y) for Young People That Have Self-Injured
- ClinicalTrials.gov ID
- NCT04708262
- Acronym / sponsor ID
- CATCHY / 287611
- Conditions
- Non-Suicidal Self Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group case series design
| Arm | Type | Receives |
|---|---|---|
| Cognitive Analytic Therapy for Containing Self-Harm in Young People | Experimental | Other: Cognitive Analytic Therapy for Containing Self-Harm in Young PeopleBrief one-to-one psychological therapy using Cognitive Analytic Therapy principles, designed for young people who self-harm |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Analytic Therapy for Containing Self-Harm in Young PeopleThe 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. | Other | Cognitive Analytic Therapy for Containing Self-Harm in Young People |
Primary outcome
Retention rate
Time frame: seven weeks
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
Time frame: Completion of study, approximately 18 months
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
Time frame: Completion of study, approximately 18 months
Completion of measurements will be analysed to test whether the level of missing data exceeds 20 percent per assessment.
Acceptability
Time frame: up to 12 weeks
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.
5 secondary outcomes
Repertory Grid
Time frame: up to 12 weeks
Motivation for Youth Treatment Scale
Time frame: up to 12 weeks
Recovery Questionnaire
Time frame: up to 12 weeks
Alexian Brothers Urges to Self-injure scale (ABUSI)
Time frame: up to 12 weeks
Patient Health Questionnaire for Adolescents (PHQ-9A)
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No. Given small scale of the study there are no plans to make the data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Analytic Therapy for Containing Self-Harm in Young People in people with Non-Suicidal Self Injury, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate (time frame: seven weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.