NCT04708262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 2, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

January 6, 2021

Last Update Submit

May 17, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (5)

  • Repertory Grid

    up to 12 weeks

  • Motivation for Youth Treatment Scale

    up to 12 weeks

  • Recovery Questionnaire

    up to 12 weeks

  • Alexian Brothers Urges to Self-injure scale (ABUSI)

    up to 12 weeks

  • Patient Health Questionnaire for Adolescents (PHQ-9A)

    up to 12 weeks

Study Arms (1)

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

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

Interventions

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.

Cognitive Analytic Therapy for Containing Self-Harm in Young People

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manchester

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group case series design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 13, 2021

Study Start

April 2, 2021

Primary Completion

December 13, 2021

Study Completion

April 1, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Given small scale of the study there are no plans to make the data available to other researchers

Locations