NCT02749240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jun 2016

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2019

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

3.5 years

First QC Date

March 22, 2016

Last Update Submit

September 2, 2020

Conditions

At Risk Youth

Outcome Measures

Primary Outcomes (12)

  • Number of potential participants approached per month.

    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.

    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.

    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.

    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.

    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.

    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

    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.

    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.

    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.

    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.

    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.

    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

Secondary Outcomes (4)

  • Community integration questionnaire

    Change from baseline to Week 4 and 8.

  • Global Appraisal of Individual Needs- Substance Problem Scale (GAIN-SPS)

    Change from baseline to Week 4 and 8.

  • Colorado Symptom Index

    Change from baseline to Week 4 and 8.

  • demographic, service and housing history (DSSH)

    Baseline

Study Arms (1)

Youth Empowerment Seminar, YES!

OTHER

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.

Other: Youth Empowerment Seminar, YES!

Interventions

Youth Empowerment Seminar, YES!OTHER

An 8-week innovative bio-psycho-social program.

Youth Empowerment Seminar, YES!

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Currently participating in other similar studies
  • Currently practicing any type of formal meditation, mindfulness or breathing techniques regularly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

  • Vasudev A, Ionson E, Sathiaselan J, Thatipalli A, Chauhan A, Hassan C, Sukhera J, Speechley M, Forchuk C. A feasibility (pilot) mixed methods study of an innovative non-pharmacological breath-based yoga and social-emotional intervention program in an at-risk youth sample in London, Canada. Pilot Feasibility Stud. 2024 Feb 7;10(1):26. doi: 10.1186/s40814-024-01452-0.

    PMID: 38321567DERIVED

MeSH Terms

Interventions

YES1 protein, human

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

April 22, 2016

Study Start

June 1, 2016

Primary Completion

December 11, 2019

Study Completion

December 11, 2019

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)