Self-harm Clinical Trial
Official title:
Randomised Controlled Trial of a Smartphone-based App to Reduce Self-harm for CAMHS-treated Adolescents
NCT number | NCT05368701 |
Other study ID # | 313791 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2022 |
Est. completion date | March 2023 |
The aim of the present research is to explore whether a brief, smartphone app-based intervention based on psychological theory can help adolescents to avoid self-harming. The smartphone app will be piloted in a randomised controlled trial (RCT) with adolescents. 90 adolescents will be recruited and assigned to one of three conditions: (a) intervention group who will complete the smartphone-based VHS app for self-harm (n = 30), (b) control group (n = 30) who will complete paper-and-pencil modified VHS, without the app, and (c) control group who will complete measures via the app but not the VHS (n = 30).
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | March 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion Criteria: - Adolescents aged between 12-18, who have been admitted to acute mental health in the past year or diagnosed with functional mental health problems Exclusion Criteria: - Individuals who cannot give informed consent, or whose parent/guardian cannot give informed consent. - Individuals under the age of 12 years |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Manchester |
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-suicidal self-harm | 'Have you ever deliberately harmed yourself in any way but not with the intention of killing yourself? (i.e., self-harm)' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked. | 6 months | |
Primary | Suicidal ideation | 'Have you ever seriously thought of taking your life, but not actually attempted to do so?' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked. | 6 months | |
Primary | Suicide attempt | 'Have you ever made an attempt to take your life, by taking an overdose of tablets or in some other way?' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked. | 6 months | |
Secondary | Exposure to suicide and mental imagery about death | Measured at baseline and follow-up using seven items adapted from those used in the literature previously (https://pubmed.ncbi.nlm.nih.gov/26247914/). Calculated as a binary variable ('yes' or 'no). Exposure to mental imagery will be calculated as a total score. | 6 months | |
Secondary | Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model) | Measured using the Capability, Opportunity, Motivation questionnaire (https://pubmed.ncbi.nlm.nih.gov/32314500/). Each of the items (0-10 scale) will be analysed separately as these each measure a separate construct. Higher scores indicate higher agreement with statements. | 6 months | |
Secondary | Habit | Measured using the self-reported habit index (automaticity scale; https://ijbnpa.biomedcentral.com/articles/10.1186/1479-5868-9-102). This consists of four items (each from 1 to 7). Items are scored from 1 to 7, with a higher mean score indicating higher agreement with the statements. | 6 months | |
Secondary | State self-regulation | Items are adapted from those used previously (https://www.tandfonline.com/doi/abs/10.1080/08870440512331317670).
Mean of the two items for each of three sub-constructs: awareness of standards, self-monitoring, and self-regulatory effort. Items are scored from 1 to 7, with higher scores indicating higher agreement with the statements. |
6 months | |
Secondary | Frequencies with which critical situations were encountered and appropriate responses were used | Frequencies | 6 months |
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