Youth Functioning and Organizational Success for West African Regional Development: Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 297
- 试验地点
- 1
- 主要终点
- Youth-level outcome measures: emotion regulation
研究概览
简要总结
Objectives: The objectives of this research proposal are to study the delivery of an evidence-based mental health intervention in the alternate setting of youth employment programs tied to regional economic development and to examine the use of an Interagency Collaborative Team Approach (ICTA) as an implementation scale-up strategy that addresses the human resource shortage and related access to care and capacity challenges in low- and middle-income countries (LMICs). Specifically, this study aims to examine the incorporation of the evidence-based Youth Readiness Intervention (YRI) into a program that promotes employment among youth through a pilot study and scale-up intervention study in Sierra Leone.
Study population: The study population includes youth participants, ages 18-26, with elevated t-scores on assessments of functional impairment and emotional dysregulation, who live in the Kailhun District of Sierra Leone.
Pilot study design: A cluster randomized three-arm trial will be employed in the pilot phase in the same districts as the scale-up study. Youth participants (N=180, 18-26 years old, 50% female), stratified by gender, will be randomized into the three study arms. Once youth participants are enrolled into the study, they will be assigned to community level sites based on geographical location. Each of these community level sites will make up one cluster. The clusters will then be randomly assigned into the three study arms so that sixty youth participants will be randomized into the youth entrepreneurship training (EPP) arm, sixty youth participants will be randomized into the YRI+EPP arm, and sixty youth participants will be randomized into the control arm . The pilot study will last approximately 12 weeks and data will be collected at baseline and post-intervention. Further, investigators will survey 120 third-party reporters for a total pilot study sample size of 300 participants.
Pilot study primary outcomes: The primary outcomes of the pilot study are to assess implementation science aspects related to a new partnership with the Deutsche Gesellschaft für Internationale Zusammenarbeit's (GIZ), who will fund and deliver the entrepreneurship training. This will include pretesting the measures battery, assessing the logistics of integrating the YRI into the entrepreneurship training, and testing use of the Interagency Collaborative Team Approach to training, supervision, and fidelity monitoring.
详细描述
Pilot study aims
- To examine the psychometric properties of an existing measures battery as well as a new battery for third-party reporting,
- To assess and adjust as needed structures for training and supervision, including the ICTA, and methods for conducting process evaluations of implementation procedures, and;
- To assess the feasibility of integrating the YRI into the entrepreneurship training (EPP) and using the ICTA to deliver an evidence-informed intervention in Sierra Leone.
Study design
The investigators are proposing to conduct a small cluster randomized pilot study with a sample of 180 youth participants, aged 18 to 26 years old. Gender within the sample will be evenly split with 50% male and 50% female youth participants. GIZ will initiate recruitment of and selection of youth participants. An electronic database will only be used by members of the research team to contact the youth participants about participating in the research study. An additional screening will be completed to ensure candidates meet specific study eligibility criteria. Given the socioemotional aims of the YRI, youth participants must demonstrate impaired functioning and emotional dysregulation.
The research team will use the information in the database to contact the EPP-selected individuals about participating in our study. Research team members will first attempt to reach EPP-selected individuals by telephone, using the telephone numbers provided in the database. If an EPP-selected individual is not reachable by telephone, the research team will attempt to locate the youth participants at their residence, using the information in the database. Because GIZ is a well-known organization in Sierra Leone that has been working in the country for many decades and supports a number of employment programs in Kono, Kailahun and Koinadugu districts, the investigators do not expect this method of contacting youth to cause them any adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Under the supervision of Innovations for Poverty Action (IPA) Sierra Leone, local research assistants (blind to site and youth condition assignments) will conduct all screening, baseline, and follow up quantitative assessments. Ongoing data collection at all sites will include youth attendance and satisfaction with YRI content, counselor satisfaction with content and delivery via scales and qualitative exit interviews, as well as monitored audio-recording of all sessions for fidelity by an independent expert rater hired by CARITAS. The expert fidelity monitor will be a skilled YRI trainer and supervisor from our prior RCT and will not be a part of the standard CTS training condition nor the ICT Seed Team, thus allowing them to provide impartial and blinded fidelity ratings of all audio-transcripts.
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Youth aged 18-26 will be included in the Youth FORWARD scale-up study based upon eligibility to the employment program, focusing specifically on socioeconomic status and willingness and interest in participation in an employment program, as well as mental health screening, which will include questions on daily functioning and emotional regulation.
- •Specifically, inclusion criteria for the youth sample is:
- •be Sierra Leonean,
- •be female or male aged 18-26,
- •be considered a vulnerable youth who is disengaged from both education and employment programs,
- •have elevated t-scores on functional impairment based on thresholds from our previous research using questions adapted from the World Health Organization Disability Assessment Schedule (WHODAS)54 and,
- •have elevated t-scores (62.5 or above) on the Disturbances in Emotion Regulation Scale (DERS).55
- •Inclusion criteria for agencies in this study is:
- •be a "service provision agency" in Sierra Leone,
- •have a minimum of two experts employed, one with subject-specific knowledge and; experience, and another with pedagogical experience in adult education and working with youth with low literacy, and
- •sign a Memorandum Of Understanding (MOU) with Boston College (BC) regarding intellectual property of the YRI.
- •Inclusion criteria for facilitators in this study is:
- •be employed by one of the agencies selected in GIZ's competitive bidding process, and
- •agree to participation in the ICTA which utilizes an enhanced supervision structure throughout the intervention.
- •Inclusion criteria for third-party reporters in this study is:
- •be over age 18,
- •be nominated by the youth participant,
- •provide oral consent to participate in the quantitative assessments, and
- •have daily to weekly contact with the youth participant throughout the duration of this scale-up study, which will be assess via verbal confirmation when obtaining oral consent.
- •Inclusion criteria for agency leaders is:
- •must be a part of one of the agencies selected in GIZ's competitive bidding process and,
- •must hold a leadership position in the agency.
排除标准
- •Exclusion criteria for the youth:
- •Youth will be excluded from the study if they do not fulfill the inclusion criteria or present with: -severe mental illness (e.g., psychosis), or
- •developmental disability that precludes comprehension of the intervention content and assessments (as determined by a study social worker using the World Health Organization Disability Assessment Screener within the Youth Screening Tool available in Appendix C).
- •Specifically, mental health exclusion criteria are:
- •severe, active suicidality or psychosis as assessed via the MINI-KID diagnostic assessment administered by a study social worker and,
- •serious cognitive impairments that might preclude one's ability to comprehend informed consent and complete study assessments as determined by a study social worker, as assessed via the Youth Screening tool (Appendix C).
- •Youth who report active suicidality or symptoms of psychosis requiring more intensive mental health care will be referred for immediate individual mental health services
- •Exclusion criteria for the agencies:
- •Agencies will be excluded from participation if:
- •they are not considered a "service provision agency", and
- •if they do not have a minimum of two experts employed (one with subject-specific knowledge and experience, and another with pedagogical experience in adult education and working with youth with low literacy)
- •Those holding leadership positions within the agencies selected to deliver the intervention will be excluded from participation in the qualitative interviews if:
- •they are not employed at the agencies selected, or
- •are not considered to be in a leadership position within the agency.
- •Exclusion criteria for the facilitators:
- •Facilitators will be excluded from participation in delivering the intervention if:
- •they are unable to deliver core components of the YRI and EPP intervention, and
- •if they are unable to meet the logistical demands of the ICTA.
- •Exclusion criteria for the third-party reporters:
- •The third-party reporter will be excluded from the study if:
- •they are under age 18
- •present with severe mental illness (e.g., psychosis), or
- •developmental disability that precludes comprehension of the intervention content and assessments (as determined by a study social worker), and
- •does not have at least monthly contact with the youth participant
研究组 & 干预措施
EPP: Entrepreneurship Programme
EPP: Entrepreneurship Programme: Youth randomized into the EPP-only arm will receive GIZ's employment programming within two weeks after the completion of the baseline assessments. The GIZ-supported EPP program includes six training modules. The modules include skills related to entrepreneurship, financial literacy, and skills building.
干预措施: EPP (Behavioral)
EPP+YRI
EPP+YRI: Youth randomized into the EPP+YRI arm will begin the Entrepreneurship programme within two weeks of baseline assessments. The entrepreneurship modules will occur for 15 days for 5 hours each day, 5 days per week. Immediately following the EPP, youth will begin receiving the YRI. The YRI curriculum (12 modules), will be delivered twice weekly over the course of 6 weeks. Each session lasts approximately 90-minutes, with additional time taken as needed. These sessions assume a peer-to-peer group learning format deemed culturally appropriate for a setting like Sierra Leone where limited resources for mental health services exist. Once youth complete the YRI they will complete a post-intervention quantitative assessment.
干预措施: YRI (Behavioral)
EPP+YRI
EPP+YRI: Youth randomized into the EPP+YRI arm will begin the Entrepreneurship programme within two weeks of baseline assessments. The entrepreneurship modules will occur for 15 days for 5 hours each day, 5 days per week. Immediately following the EPP, youth will begin receiving the YRI. The YRI curriculum (12 modules), will be delivered twice weekly over the course of 6 weeks. Each session lasts approximately 90-minutes, with additional time taken as needed. These sessions assume a peer-to-peer group learning format deemed culturally appropriate for a setting like Sierra Leone where limited resources for mental health services exist. Once youth complete the YRI they will complete a post-intervention quantitative assessment.
干预措施: EPP (Behavioral)
Control
Control: Youth randomized into the control arm will be quantitatively assessed at the same time points as youth randomized into the two treatment arms (baseline and post-intervention). Due to access to funding and feasibility, youth in the control arm will not have the opportunity to receive the YRI once the study period concludes. However, GIZ is conducting a phased roll out of their EPP programming, meaning they will offer their EPP throughout 2018 past their participation in Youth FORWARD. The list of youth from the control group will be provided to GIZ so they can participate in the future phases. Youth will also be compensated for their participation in our quantitative assessments.
结局指标
主要结局
Youth-level outcome measures: emotion regulation
时间窗: baseline and 3-months (post-intervention)
Change in youth mental emotion regulation will be assessed via the following measure: • Difficulties in Emotion Regulation (DERS), clinical threshold for emotion dysregulation set at a score of 62.5, range of scores is from 36-180, higher scores denote higher levels of emotion dysregulation
次要结局
- Youth-level outcome measure: youth employment and economic self-sufficiency(baseline and 3-months (post-intervention))