NCT02561949

Brief Summary

The research will first examine data obtained from YRI participants to investigate effects of the group sessions on psychosocial functioning outcomes in youth aged 15 - 24. The research also intends to examine whether youth participating in YRI and complementary income generating activities will fare better than an employment only control group. Finally, the research intends to examine whether utilizing lay health workers are a is cost-effective and scalable method for addressing mental health concerns. The research will investigate the following hypotheses:

  1. 1.Participants who are exposed to YRI will demonstrate greater reduction in mental health and behavioral problems than participants who are waitlisted for YRI over the same period; emotion regulation will operate as a major mechanism of YRI improvements; high comorbidity will be a treatment modifier;
  2. 2.Improvements in mental health and functioning due to YRI will lead to (mediate) greater employment outcomes and superior economic self-sufficiency over time; and
  3. 3.Homelessness, orphanhood, young parenthood, and high problems in emotion regulation co-morbid with other mental health conditions will be major moderators lessening the effectiveness of YRI.
  4. 4.Lay and trained practitioners at agencies participating in the combined mental health-employment program will demonstrate high fidelity to evidence-based treatment components and that good satisfaction, social support, and professional exchange of evidence-based practices will emerge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

September 25, 2015

Last Update Submit

May 30, 2018

Conditions

Keywords

Depression/therapyDeveloping CountriesInterpersonal RelationsLife Change EventsPsychotherapy, groupResilience, PsychologicalSierra LeoneSurvivors/psychologySocial AdjustmentSocial BehaviorWar

Outcome Measures

Primary Outcomes (1)

  • Change in % of youth with improved health outcomes

    The percent of youth with improved mental health and daily functioning will be measured through a quantitative assessment battery including measurements from the Hopkins Symptoms Checklist, Oxford Measure of Psychosocial Adjustment, Ways of Coping Questionnaire, UCLA Traumatic Stress Disorder Reaction Index, World Health Organization Disability Adjustment Scale, Difficulties in Emotion Regulation Scale.

    Baseline, 3 months, 6 months, and 12 months

Secondary Outcomes (2)

  • YRI Fidelity Protocol

    3 months

  • Change in knowledge, attitudes, and behaviors of youth around employment and access to employment services.

    6 months

Study Arms (2)

YRI + Employment Program

EXPERIMENTAL

Immediately following enrollment participants will complete the YRI intervention, followed by an income generating activity program.

Behavioral: YRIOther: Income generating activity program

Employment Program

EXPERIMENTAL

Immediately following enrollment participants will complete an income generating activity program.

Other: Income generating activity program

Interventions

YRIBEHAVIORAL

Youth Readiness Intervention (YRI) is an innovative, evidence-based mental health intervention to address co-morbid difficulties with externalizing problems (anger/emotion dysregulation) and internalizing problems (hopelessness/anxiety) among violence-affected youth. YRI methodology draws on evidence-based treatment elements commonly used in both cognitive-behavioral intervention and group interpersonal therapy. YRI has cross-cutting efficacy across a range of mental health conditions common in violence-affected youth. YRI will be delivered in 12 sessions over the course of 3 months.

Also known as: Youth Readiness Intervention
YRI + Employment Program

Income generating activity programming will be carried out by GOAL in partnership with St. George's foundation through use of their current funding. GOAL focuses on supporting people in need by providing healthcare resources, advocating and advancing child protection practices and policies, and administering livelihood programs to empower them improve their lives in a sustainable manner. The St. George's Foundation's addresses child welfare concerns by actively reaching out to homeless and orphaned children. The program is 4 months in length and consists of skills training, soft skills development (primarily in numeracy and literacy), and a cash transfer of $200.

Employment ProgramYRI + Employment Program

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants must be between the ages 15-24 (UN definition of youth);
  • Participants must have an elevated score on internalizing (depression/anxiety) or externalizing (aggression/ hostility) on a measure validated for use in Sierra Leone;
  • Participants must report some impairment in daily functioning as a result of emotional or behavior problems based on a series of questions adapted from the WHODAS; and
  • Participants must neither be enrolled in school nor have gainful employment of 20 or more hours of work per week over the past four weeks.

You may not qualify if:

  • Participant fails to meet the age requirements;
  • Participant is either currently enrolled in school or has gainful employment of 20 hours or more of work per week over the past four weeks;
  • Participant is not in favor of joining an employment program;
  • Participants does not have an elevated score on internalizing (depression/anxiety) or externalizing (aggression/ hostility) on a measure validated for use in Sierra Leone;
  • Participant does not report some impairment in daily functioning as a result of emotional or behavior problems based on a series of questions adapted from the WHODAS;
  • Participant identified by clinical staff as: (a) experiencing suicidality, or (b) psychosis.
  • Participants at risk of harm to themselves or others, as well as those requiring treatment beyond the scope of YRI will be referred to local mental health or social work treatment facilitates as appropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CARITAS

Freetown, Sierra Leone

Location

MeSH Terms

Conditions

Anxiety DisordersDepressive DisorderDepressionSocial AdjustmentSocial Behavior

Condition Hierarchy (Ancestors)

Mental DisordersMood DisordersBehavioral SymptomsBehavior

Study Officials

  • Theresa Betancourt, ScD, MA

    Harvard University T.H. Chan School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Salem Professor in Global Practice

Study Record Dates

First Submitted

September 25, 2015

First Posted

September 28, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

May 31, 2018

Record last verified: 2018-05

Locations