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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04708262
Other study ID # 287611
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2, 2021
Est. completion date April 1, 2022

Study information

Verified date May 2022
Source University of Manchester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date April 1, 2022
Est. primary completion date December 13, 2021
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cognitive Analytic Therapy for Containing Self-Harm in Young People
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.

Locations

Country Name City State
United Kingdom University of Manchester Manchester

Sponsors (1)

Lead Sponsor Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. seven weeks
Primary 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. Completion of study, approximately 18 months
Primary Missing data Completion of measurements will be analysed to test whether the level of missing data exceeds 20 percent per assessment. Completion of study, approximately 18 months
Primary 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. up to 12 weeks
Secondary 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. up to 12 weeks
Secondary 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). up to 12 weeks
Secondary 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). up to 12 weeks
Secondary 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). up to 12 weeks
Secondary 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). up to 12 weeks
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