At Risk Youth Clinical Trial
Official title:
A Feasibility (Pilot) Study of an Innovative Non-pharmacological Intervention Program in at Risk Youth
| Verified date | September 2020 |
| Source | Lawson Health Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
At risk youth face various adversities including homelessness, social isolation, substance abuse and other mental illnesses. Thus far, the investigators have successfully partnered on programs of housing, social and recreational interventions in this population. The investigators now wish to assess the feasibility of delivery of an innovative bio-psycho-social intervention, Youth Empowerment Seminar (YES!), developed by their partner, the not-for-profit Art of Living Foundation. Therefore, the aim of this research is to conduct a proof of concept study to determine the feasibility of a novel YES! program as an intervention for at risk youth.
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | December 11, 2019 |
| Est. primary completion date | December 11, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 25 Years |
| Eligibility |
Inclusion Criteria: - Between 16-25 years of age - Currently precariously housed and accessing resources offered by Youth Opportunities Unlimited - Have sufficient hearing to be able to follow verbal instructions and able to sit without physical discomfort for 30 minutes - Willing and able to attend 4 initial YES! training sessions and at least 5 of weekly follow up sessions. - Willing to dedicate 20 minutes/daily to SKY practice Exclusion Criteria: - Currently participating in other similar studies - Currently practicing any type of formal meditation, mindfulness or breathing techniques regularly. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | London Health Sciences Centre | London | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Lawson Health Research Institute |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of potential participants approached per month. | The number of potential participants approached per month will be assessed at the end of each month. This information will be used to determine the feasibility of a larger Randomized Controlled Trial (RCT) that would examine the YES! program in at risk youth. | Through study completion, an average of one year | |
| Primary | Number (proportion) of participants who are successfully screened. | The number (proportion) of participants who are successfully screened will be calculated at the end of the study. This information will be used to determine the feasibility of a larger Randomized Controlled Trial (RCT) that would examine the YES! program in at risk youth. | Through study completion, an average of one year | |
| Primary | Number (proportion) of successfully screened participants who enroll. | The number (proportion) of successfully screened participants who enroll in the study will be calculated at the end of the study. This information will be used to determine the feasibility of a larger Randomized Controlled Trial (RCT) that would examine the YES! program in at risk youth. | Through study completion, an average of one year | |
| Primary | Rate of participant retention. | The rate of participant retention will be assessed at the end of the study. This information will be used to determine the feasibility of a larger Randomized Controlled Trial (RCT) that would examine the YES! program in at risk youth. | Through study completion, an average of one year | |
| Primary | Rate of adherence to study protocol. | At the end of the study any deviations from the protocol will be examined to determine the rate of adherence to the study protocol. This information will be used to determine the feasibility of a larger Randomized Controlled Trial (RCT) that would examine the YES! program in at risk youth. | Through study completion, an average of one year | |
| Primary | Proportion of planned ratings that are completed. | The proportion of completed planned ratings will be calculated at the end of the study. This information will be used to determine the feasibility of a larger Randomized Controlled Trial (RCT) that would examine the YES! program in at risk youth. | Through study completion, an average of one year | |
| Primary | Intervention cost per case | The cost per participant of attending the YES! program will be calculated. This information will be used to determine the feasibility of a larger Randomized Controlled Trial (RCT) that would examine the YES! program in at risk youth. | Through study completion, an average of one year | |
| Primary | Completeness of final data for analysis. | Study data used for analysis will be examined at the end of the study to assess the completeness of the data. This information will be used to determine the feasibility of a larger Randomized Controlled Trial (RCT) that would examine the YES! program in at risk youth. | Through study completion, an average of one year | |
| Primary | Length of time to collect all data. | The length of time to collect all study data will be calculated at the end of the study. This information will be used to determine the feasibility of a larger Randomized Controlled Trial (RCT) that would examine the YES! program in at risk youth. | Through study completion, an average of one year | |
| Primary | Quality of all collected data. | At the end of the study the quality of all collected data will be assessed. This information will be used to determine the feasibility of a larger Randomized Controlled Trial (RCT) that would examine the YES! program in at risk youth. | Through study completion, an average of one year | |
| Primary | Determining if YOU is willing to conduct the study as per study protocol. | At the end of the study any deviations YOU has made from study protocol will be assessed. This information will be used to determine the feasibility of a larger Randomized Controlled Trial (RCT) that would examine the YES! program in at risk youth. | Through study completion, an average of one year | |
| Primary | Assess if it is safe to apply the intervention. | At the end of the study all recorded adverse events will be assessed. This information will be used to determine the feasibility of a larger Randomized Controlled Trial (RCT) that would examine the YES! program in at risk youth. | Through study completion, an average of one year | |
| Secondary | Community integration questionnaire | The Community Integration Questionnaire will be used to assess the social role and community interaction participants have at baseline compared to week 4 and week 8. | Change from baseline to Week 4 and 8. | |
| Secondary | Global Appraisal of Individual Needs- Substance Problem Scale (GAIN-SPS) | The Global Appraisal of Individual Needs - Substance Problem Scale (GAIN-SPS) will be used to assess any change in substance problems from baseline to week 4 and week 8. | Change from baseline to Week 4 and 8. | |
| Secondary | Colorado Symptom Index | The Colorado Symptom Index will be used to assess any change is psychiatric symptoms from baseline to week 4 and week 8. | Change from baseline to Week 4 and 8. | |
| Secondary | demographic, service and housing history (DSSH) | At baseline information will be collected on participants demographics and their service and housing history. | Baseline |