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

2. září 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

39

Fáze

  • Raná fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Kanada
    • Ontario
      • London, Ontario, Kanada, N6A 5W9
        • London Health Sciences Centre

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

16 let až 25 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Jiný: 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.
Jiný: Youth Empowerment Seminar, YES!
An 8-week innovative bio-psycho-social program.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of potential participants approached per month.
Časové okno: 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.
Through study completion, an average of one year
Number (proportion) of participants who are successfully screened.
Časové okno: 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
Number (proportion) of successfully screened participants who enroll.
Časové okno: 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
Rate of participant retention.
Časové okno: 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
Rate of adherence to study protocol.
Časové okno: 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.
Through study completion, an average of one year
Proportion of planned ratings that are completed.
Časové okno: 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
Intervention cost per case
Časové okno: 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
Completeness of final data for analysis.
Časové okno: 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
Length of time to collect all data.
Časové okno: 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
Quality of all collected data.
Časové okno: 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.
Through study completion, an average of one year
Determining if YOU is willing to conduct the study as per study protocol.
Časové okno: 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.
Through study completion, an average of one year
Assess if it is safe to apply the intervention.
Časové okno: 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.
Through study completion, an average of one year

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Community integration questionnaire
Časové okno: Change from baseline to Week 4 and 8.
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.
Global Appraisal of Individual Needs- Substance Problem Scale (GAIN-SPS)
Časové okno: 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.
Change from baseline to Week 4 and 8.
Colorado Symptom Index
Časové okno: 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.
Change from baseline to Week 4 and 8.
demographic, service and housing history (DSSH)
Časové okno: Baseline
At baseline information will be collected on participants demographics and their service and housing history.
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Lawson Health Research Institute

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. června 2016

Primární dokončení (Aktuální)

11. prosince 2019

Dokončení studie (Aktuální)

11. prosince 2019

Termíny zápisu do studia

První předloženo

22. března 2016

První předloženo, které splnilo kritéria kontroly kvality

21. dubna 2016

První zveřejněno (Odhad)

22. dubna 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. září 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. září 2020

Naposledy ověřeno

1. září 2020

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 107708

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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