A Feasibility (Pilot) Study of an Innovative Non-pharmacological Intervention Program in at Risk Youth
2020년 9월 2일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
39
단계
- 초기 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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London, Ontario, 캐나다, N6A 5W9
- London Health Sciences Centre
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
16년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of potential participants approached per month.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
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Through study completion, an average of one year
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Rate of adherence to study protocol.
기간: 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.
기간: 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.
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Through study completion, an average of one year
|
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Intervention cost per case
기간: 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.
기간: 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.
기간: Through study completion, an average of one year
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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.
기간: Through study completion, an average of one year
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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.
기간: 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.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Community integration questionnaire
기간: 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)
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 6월 1일
기본 완료 (실제)
2019년 12월 11일
연구 완료 (실제)
2019년 12월 11일
연구 등록 날짜
최초 제출
2016년 3월 22일
QC 기준을 충족하는 최초 제출
2016년 4월 21일
처음 게시됨 (추정)
2016년 4월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 9월 2일
마지막으로 확인됨
2020년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 107708
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아니요
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