A Feasibility (Pilot) Study of an Innovative Non-pharmacological Intervention Program in at Risk Youth
2 september 2020 uppdaterad av: Lawson Health Research Institute
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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:
- demographic, service and housing history
- community integration questionnaire
- 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
- Colorado Symptom Index.
Studietyp
Interventionell
Inskrivning (Faktisk)
39
Fas
- Tidig fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Ontario
-
London, Ontario, Kanada, N6A 5W9
- London Health Sciences Centre
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
16 år till 25 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Youth Empowerment Seminar, YES!
An 8-week innovative bio-psycho-social program (Youth Empowerment Seminar, YES!) will be offered to at risk youth participating in programs or resources offered by Youth Opportunities Unlimited.
The YES! program will be taught in two phases: (1) an active learning phase which consists of four consecutive days (3 hrs/day) of SEL skills taught in a multi-modality interactive format as well as SKY training, and (2) a reinforcement phase which involves weekly follow up sessions (75-90 mins each) for the 7 weeks following the active phase.
Two certified instructors from the Art of Living Foundation (Spencer Delisle and Mark Frye) will deliver this training under supervision of Ronnie Newman (RN).
After the initial 4 day training, participants will be asked to practice SKY daily for 20-25 minutes in addition to attending the weekly follow up sessions.
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An 8-week innovative bio-psycho-social program.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of potential participants approached per month.
Tidsram: Through study completion, an average of one year
|
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.
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Through study completion, an average of one year
|
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Number (proportion) of participants who are successfully screened.
Tidsram: Through study completion, an average of one year
|
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
|
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Number (proportion) of successfully screened participants who enroll.
Tidsram: Through study completion, an average of one year
|
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
|
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Rate of participant retention.
Tidsram: Through study completion, an average of one year
|
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
|
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Rate of adherence to study protocol.
Tidsram: Through study completion, an average of one year
|
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.
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Through study completion, an average of one year
|
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Proportion of planned ratings that are completed.
Tidsram: Through study completion, an average of one year
|
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
|
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Intervention cost per case
Tidsram: Through study completion, an average of one year
|
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
|
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Completeness of final data for analysis.
Tidsram: Through study completion, an average of one year
|
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
|
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Length of time to collect all data.
Tidsram: Through study completion, an average of one year
|
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
|
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Quality of all collected data.
Tidsram: Through study completion, an average of one year
|
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.
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Through study completion, an average of one year
|
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Determining if YOU is willing to conduct the study as per study protocol.
Tidsram: Through study completion, an average of one year
|
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.
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Through study completion, an average of one year
|
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Assess if it is safe to apply the intervention.
Tidsram: Through study completion, an average of one year
|
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.
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Through study completion, an average of one year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Community integration questionnaire
Tidsram: Change from baseline to Week 4 and 8.
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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.
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Change from baseline to Week 4 and 8.
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Global Appraisal of Individual Needs- Substance Problem Scale (GAIN-SPS)
Tidsram: Change from baseline to Week 4 and 8.
|
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.
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Change from baseline to Week 4 and 8.
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Colorado Symptom Index
Tidsram: Change from baseline to Week 4 and 8.
|
The Colorado Symptom Index will be used to assess any change is psychiatric symptoms from baseline to week 4 and week 8.
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Change from baseline to Week 4 and 8.
|
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demographic, service and housing history (DSSH)
Tidsram: Baseline
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At baseline information will be collected on participants demographics and their service and housing history.
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Baseline
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2016
Primärt slutförande (Faktisk)
11 december 2019
Avslutad studie (Faktisk)
11 december 2019
Studieregistreringsdatum
Först inskickad
22 mars 2016
Först inskickad som uppfyllde QC-kriterierna
21 april 2016
Första postat (Uppskatta)
22 april 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 september 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 september 2020
Senast verifierad
1 september 2020
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 107708
Plan för individuella deltagardata (IPD)
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NEJ
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