Self Harm Clinical Trial
Official title:
Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP) in Adolescents Pakistani Patients With a History of Self Harm
Verified date | March 2023 |
Source | Pakistan Institute of Living and Learning |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the clinical and cost-effectiveness of a youth culturally adapted manual assisted therapy (YCMAP) in Pakistani Adolescents with a history of self-harm
Status | Completed |
Enrollment | 684 |
Est. completion date | February 28, 2023 |
Est. primary completion date | September 8, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion Criteria: - Patients age 12-18 years presenting to the participating GPs, emergency departments or admitted after an episode of self-harm to the participating hospitals or self-referrals. - History of recent self-harm. Recent self-harm is defined as self-harm occurring within the last 3 months (from the initial identification of a potential participant). - Participants living within the catchment area of the participating practices and hospitals. - Not needing inpatient psychiatric treatment. Exclusion Criteria: - Severe mental illness (such as Psychotic disorder) as Self-harm commonly co- occurs with other mental health difficulties. - Conditions limiting engagement with assessment or intervention, including developmental and communication disorders, intellectual disabilities and autistic spectrum disorders. - Temporary resident unlikely to be available for follow up. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Karachi Site | Karachi | Sindh |
Pakistan | Lahore Site | Lahore | |
Pakistan | Rawalpindi Site | Rawalpindi |
Lead Sponsor | Collaborator |
---|---|
Pakistan Institute of Living and Learning | University of Manchester |
Pakistan,
Andrews G, Slade T. Interpreting scores on the Kessler Psychological Distress Scale (K10). Aust N Z J Public Health. 2001 Dec;25(6):494-7. doi: 10.1111/j.1467-842x.2001.tb00310.x. — View Citation
Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x. — View Citation
Beck, A. T., & Steer, R. A. (1991). BSI, Beck scale for suicide ideation: manual: Psychological Corporation.
Beck, A., & Steer, R. J. S. A., TX: Psychological Corporation. (1988). Manual for the Beck hopelessness scale
Beecham, J., & Knapp, M. J. M. m. h. n. (2001). Costing psychiatric interventions. 2, 200-224.
Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6. — View Citation
Linehan MM, Comtois KA, Brown MZ, Heard HL, Wagner A. Suicide Attempt Self-Injury Interview (SASII): development, reliability, and validity of a scale to assess suicide attempts and intentional self-injury. Psychol Assess. 2006 Sep;18(3):303-12. doi: 10.1037/1040-3590.18.3.303. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Suicide Attempt Self Injury Interview SASII | Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII). Higher number on repetition indicates worse outcome and vice versa | Change in scores from baseline to 12th months | |
Secondary | Beck Scale for Suicidal ideation (BSI) | Suicidal ideation will be assessed with the Beck Scale for Suicide Ideation (BSS; Beck & Steer, 1991), a 19-item self-report questionnaire, measuring the intensity and frequency of suicidal thoughts within the past week. Minimum total score is 0 and maximum total score can be 38. Higher scores indicate worse outcome. | Change in scores from Baseline to 3rd, 6th, 9th and 12th month. | |
Secondary | Beck Hopelessness Scale | This is a 20 items scale measuring hopelessness. Higher scores on the scale indicate greater severity of hopelessness. Minimum total score on this scale can be 0 and maximum total score can be 20, with higher levels of hopelessness indicated by higher scores on the scale. | [Time Frame: Baseline,3rd,6th,9th and 12th months] | |
Secondary | Psychological Distress Scale | It's a 10 item scale measuring emotional states with a 5 level response scale. The maximum score is 50 indicating severe distress, and the minimum score is 10 indicating no distress. | Change in scores from Baseline to 3rd, 6th, 9th and 12th month. | |
Secondary | EuroQol-5 Dimensions (EQ5-D) | A standardised instrument to measure health status and associated population utility weights. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression). | Change in scores from Baseline to 3rd, 6th, 9th and 12th month. | |
Secondary | Client Satisfaction Questionnaire (CSQ). | The participants will rate their satisfaction with treatment by using the CSQ. The total score ranges from 8 to 32. Higher scores indicate higher level of satisfaction. | Change in scores from Baseline to 3rd, 6th, 9th and 12th month. | |
Secondary | Client Services Receipt Inventory CSRI | We will collect information on the use of health services (including the informal sector such as faith healers/Imams) | Change in scores from Baseline to 3rd, 6th, 9th and 12th month. |
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