A Feasibility (Pilot) Study of an Innovative Non-pharmacological Intervention Program in at Risk Youth
2020年9月2日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
39
段階
- 初期フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Ontario
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London、Ontario、カナダ、N6A 5W9
- London Health Sciences Centre
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
16年～25年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of potential participants approached per month.
時間枠：Through study completion, an average of one year
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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.
時間枠：Through study completion, an average of one year
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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.
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Through study completion, an average of one year
|
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Number (proportion) of successfully screened participants who enroll.
時間枠：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.
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Through study completion, an average of one year
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Rate of participant retention.
時間枠：Through study completion, an average of one year
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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.
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Through study completion, an average of one year
|
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Rate of adherence to study protocol.
時間枠：Through study completion, an average of one year
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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.
時間枠：Through study completion, an average of one year
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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.
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Through study completion, an average of one year
|
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Intervention cost per case
時間枠：Through study completion, an average of one year
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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.
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Through study completion, an average of one year
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Completeness of final data for analysis.
時間枠：Through study completion, an average of one year
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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.
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Through study completion, an average of one year
|
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Length of time to collect all data.
時間枠：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.
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Through study completion, an average of one year
|
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Quality of all collected data.
時間枠：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.
時間枠：Through study completion, an average of one year
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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.
時間枠：Through study completion, an average of one year
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Community integration questionnaire
時間枠：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)
時間枠：Change from baseline to Week 4 and 8.
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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
時間枠：Change from baseline to Week 4 and 8.
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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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年6月1日
一次修了 (実際)
2019年12月11日
研究の完了 (実際)
2019年12月11日
試験登録日
最初に提出
2016年3月22日
QC基準を満たした最初の提出物
2016年4月21日
最初の投稿 (見積もり)
2016年4月22日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月4日
QC基準を満たした最後の更新が送信されました
2020年9月2日
最終確認日
2020年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 107708
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いいえ
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