Clinical Trials Directory

Trials / Completed

CompletedNCT02749240

A Feasibility (Pilot) Study of an Innovative Non-pharmacological Intervention Program in at Risk Youth

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
39 (actual)
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
Sex
All
Age
16 Years – 25 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

STUDY DESIGN: The proposed is an open-label study with a mixed methods design. Research participants will be thirty youth between the ages of 16-25 years who are currently accessing any resource offered by Youth Opportunities Unlimited, London, ON. Youth will be enrolled in a rolling 8-week YES! Program repeated when adequate group size is achieved (\>6 participants). Quantitative and qualitative data will be collected, which will allow for a detailed analysis of the feasibility of YES! as an intervention for youth at risk of homelessness. STUDY RECRUITMENT: Participants for this study will be recruited through the Youth Action Centre (YAC) of Youth Opportunity Unlimited (YOU), London. Participants will be between 16 and 25 years of age. As this is a pilot study, the investigators have set the sample size to n=30, which is in accordance with current standards for pilot studies. The investigators anticipate to recruit participants at a rate of at least 1 youth/week. Advertisements about the study will be placed throughout YAC (located in the YOU Cornerstone Building, 332 Richmond St., London, ON, N6A 3C3) and Theresa McLachlan, a staff member with YOU Transition Services will provide interested youth with additional information as required. There is no obligation for the youth to take part in the study; all participation is voluntary. SCREENING AND INITIAL ASSESSMENTS: Potential participants will be screened as per inclusion and exclusion criteria by trained research staff. Immediately prior to the start of the intervention trained raters will meet with participants to obtain demographic information and complete baseline measures of social inclusion, substance use and mental health. Specifically, the following scales will be administered: 1. demographic, service and housing history 2. community integration questionnaire 3. Global Appraisal of Individual Needs- Substance Problem Scale (GAIN-SPS), (GAIN-SPS is a subscale of a biopsychosocial battery that has been designed for clinical and program evaluation and has been validated for use in individuals 11 years of age and older), and 4. Colorado Symptom Index.

Conditions

Interventions

TypeNameDescription
OTHERYouth Empowerment Seminar, YES!An 8-week innovative bio-psycho-social program.

Timeline

Start date
2016-06-01
Primary completion
2019-12-11
Completion
2019-12-11
First posted
2016-04-22
Last updated
2020-09-04

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02749240. Inclusion in this directory is not an endorsement.