Clinical trial NCT02749240: A Feasibility (Pilot) Study of an Innovative Non-pharmacological Intervention Program in at Risk Youth
Official title: A Feasibility (Pilot) Study of an Innovative Non-pharmacological Intervention Program in at Risk Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: At Risk Youth
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 39
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of potential participants approached per month.
timeFrame: Through study completion, an average of one year
measure: Number (proportion) of participants who are successfully screened.
timeFrame: Through study completion, an average of one year
measure: Number (proportion) of successfully screened participants who enroll.
timeFrame: Through study completion, an average of one year
measure: Rate of participant retention.
timeFrame: Through study completion, an average of one year
measure: Rate of adherence to study protocol.
timeFrame: Through study completion, an average of one year
measure: Proportion of planned ratings that are completed.
timeFrame: Through study completion, an average of one year
measure: Intervention cost per case
timeFrame: Through study completion, an average of one year
measure: Completeness of final data for analysis.
timeFrame: Through study completion, an average of one year
measure: Length of time to collect all data.
timeFrame: Through study completion, an average of one year
measure: Quality of all collected data.
timeFrame: Through study completion, an average of one year
measure: Determining if YOU is willing to conduct the study as per study protocol.
timeFrame: Through study completion, an average of one year
measure: Assess if it is safe to apply the intervention.
timeFrame: Through study completion, an average of one year
Secondary outcomes:
measure: Community integration questionnaire
timeFrame: Change from baseline to Week 4 and 8.
measure: Global Appraisal of Individual Needs- Substance Problem Scale (GAIN-SPS)
timeFrame: Change from baseline to Week 4 and 8.
measure: Colorado Symptom Index
timeFrame: Change from baseline to Week 4 and 8.
measure: demographic, service and housing history (DSSH)
timeFrame: Baseline
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References: