Trial of the Youth Readiness Intervention (YRI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
CARITAS Freetown
International Rescue Committee
Harvard Medical School
Yale University
The City College of New York
Information provided by (Responsible Party):
Theresa Betancourt, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01684488
First received: March 19, 2012
Last updated: August 23, 2014
Last verified: August 2014
  Purpose

The research will first examine data obtained from YRI participants to investigate effects of the group sessions on psychosocial and functioning outcomes in youth.

In pursuit of this aim, this research will investigate the following hypothesis: Participation in the Youth Readiness Intervention will reduce symptoms of internalizing, externalizing, trauma-related symptoms, and improve prosocial skills and functioning among war-affected 15-24 year olds in Sierra Leone.

The research also intends to examine whether youth enrolled in a psychosocial "Youth Readiness Intervention" (YRI) and a complementary education program fare better than an education-only control group, a psychosocial-only control group, and a waitlist control group.

In pursuit of this second aim, this research will investigate the following hypothesis: A combined psychosocial-education program is an effective paradigm for improving psychosocial, functional, educational, and economic self-sufficiency outcomes among war-affected youth.


Condition Intervention
Anxiety Disorder/Anxiety State
Depressive Disorder/Psychology;
Social Problems/Psychology;
Stress, Psychological;
Violence, Non-accidental
Behavioral: Youth Readiness Intervention
Other: EducAid educational programming

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Feasibility Trial of the Youth Readiness Intervention: A Group Psychosocial Intervention for War-affected Youth in Sierra Leone

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) [ Time Frame: Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI ] [ Designated as safety issue: No ]
    Primary outcomes of interest include changes in depression, anxiety, hostility, confidence, and pro-social behaviors. These constructs will be measured by the Oxford Refugee Studies Psychosocial Adjustment Scale. An additional primary outcome, daily functioning, will be assessed by the World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0). Both measures are incorporated within the study's comprehensive Youth Assessment Battery.


Secondary Outcome Measures:
  • Change in scores on the Youth Assessment Battery [ Time Frame: Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI ] [ Designated as safety issue: No ]
    Secondary outcomes include the participant's interpersonal and community relations, experience of daily hardships, coping skills, post-traumatic stress, emotion regulation, health, risk behaviors, and other constructs as they relate to the YRI intervention areas.


Enrollment: 443
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Waitlist+EducAid
Immediately following enrollment, participants do not immediately receive any intervention. At 3 months, they are enrolled in EducAid educational programming for the 2012-2013 academic year.
Other: EducAid educational programming
EducAid is a charitable trust that provides free year-round education to over 1,500 youth, along with food, medicine, and shelter when needed. EducAid's education model aims to improve academic knowledge, self-efficacy, and attitudes toward school. Additionally, it aims to nurture hope for the future and a sense of normalcy through interactions with teachers, mentors, and peers.
No Intervention: Waitlist
Participants do not receive any intervention throughout the trial period. Once the trial has concluded, participants are invited to enroll in EducAid educational programming for the 2013-2014 academic year.
Experimental: YRI only
Immediately following enrollment, participants complete the YRI. They are then placed on a waitlist for the remainder of the trial. At the end of the trial, participants are invited to enroll in EducAid educational programming for the 2013-2014 academic year.
Behavioral: Youth Readiness Intervention
The YRI brings together six empirically-supported practice elements shown to be efficacious across different mental health interventions, as well as methods intended to socialize youth and improve self-efficacy. Practice elements address the broad scope of problems evidenced in Sierra Leonean war-affected youth and enhance the YRI's pacing, which progresses through three phases traditionally used in trauma treatments (stabilization, integration, connection). The weekly intervention takes place over 10 sessions lasting approximately one hour and a half. Groups are divided by gender and age. Each group is paired with two interventionists of the same gender.
Other: EducAid educational programming
EducAid is a charitable trust that provides free year-round education to over 1,500 youth, along with food, medicine, and shelter when needed. EducAid's education model aims to improve academic knowledge, self-efficacy, and attitudes toward school. Additionally, it aims to nurture hope for the future and a sense of normalcy through interactions with teachers, mentors, and peers.
Experimental: YRI+EducAid
Immediately following enrollment, participants complete the YRI. Participants are then immediately enrolled in EducAid educational programming for the 2012-2013 academic year.
Behavioral: Youth Readiness Intervention
The YRI brings together six empirically-supported practice elements shown to be efficacious across different mental health interventions, as well as methods intended to socialize youth and improve self-efficacy. Practice elements address the broad scope of problems evidenced in Sierra Leonean war-affected youth and enhance the YRI's pacing, which progresses through three phases traditionally used in trauma treatments (stabilization, integration, connection). The weekly intervention takes place over 10 sessions lasting approximately one hour and a half. Groups are divided by gender and age. Each group is paired with two interventionists of the same gender.
Other: EducAid educational programming
EducAid is a charitable trust that provides free year-round education to over 1,500 youth, along with food, medicine, and shelter when needed. EducAid's education model aims to improve academic knowledge, self-efficacy, and attitudes toward school. Additionally, it aims to nurture hope for the future and a sense of normalcy through interactions with teachers, mentors, and peers.

Detailed Description:

In Sierra Leone, a dangerous gap remains between long-term psychosocial needs and adequate services. As youth affected by the war begin to enter adulthood, they face new challenges including unemployment, interrupted education, the need to support families, marginalization and stigma, as well as the remaining psychological effects of exposure to war. Healthy social integration is critical to the long-term wellbeing of this generation, but the evidence base on effective interventions to improve skills and self-efficacy is severely limited. Despite the high burden of mental health problems among war-affected youth in Sub-Saharan Africa, few empirically-supported behavioral treatments (ESBTs) or evidence-based interventions have been implemented in this region. This study stands to make an important contribution to knowledge on effective and culturally-sensitive mental health services that can be implemented in settings fraught by multiple hardships, including war, poverty, low educational attainment, and other hardships.

This randomized study of 416 school-intending youth age 15-24 will use a parallel design to examine the potential benefits of enrolling in a psychosocial intervention--the YRI--prior to enrolling in an educational program. Assessments will be performed pre-/post-intervention and at 6-month and 12-month follow-ups. These long-term evaluations will examine whether benefits are sustained, accrue, or depreciate over time. Data will improve understanding of how a psychosocial-education intervention translates to economic outcomes like employment, as compared to an education-only intervention.

The YRI is an evidence-based group intervention developed in 2010 to address key emotional, behavioral, and functioning difficulties identified by the PI's prior longitudinal study of war-affected youth. It is designed to reduce symptoms of internalizing, externalizing, trauma-related symptoms, and improve prosocial skills and functioning among war-affected 15-24 year olds. The YRI has three overarching goals: (1) To improve interpersonal and community relationships through work with youth and community members; (2) To help vulnerable youth develop skills in emotional regulation, problem-solving, and interpersonal interactions necessary to be successful members of their communities; (3) To promote the healthy integration of difficult memories for youth who experience difficulties due to traumatic exposure. Primary mental health outcomes include decreased anxiety, hostility, and depression, and increased pro-social attitudes, as measured by the Oxford Refugee Studies Psychosocial Adjustment Scale and the African Youth Psychosocial Assessment.

EducAid is a charitable trust established in 1994. Devoted to promoting education among underprivileged and war-affected young people in Sierra Leone through holistic and academic learning, EducAid provides free year-round education to over 1,500 youth, along with food, medicine, and shelter when needed. EducAid has a keen interest in exploring how psychosocial interventions can promote academic, social, and emotional well-being in students. EducAid's education model aims to improve academic knowledge, self-efficacy, and attitudes toward school. Additionally, it aims to nurture hope for the future and a sense of normalcy through interactions with teachers, mentors, and peers. Following participation in the education component, participants' employment and economic activity will be assessed using standardized instruments for cross-cultural work, including the World Bank Living Standards Surveys.

  Eligibility

Ages Eligible for Study:   15 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Once youth are referred to the study, a screening tool will be administered to determine whether or not they meet eligibility requirements as described below.

The screening tool contains four sections;

  1. Consent and Age: assures that participants meet the age requirements
  2. Oxford Refugees Psychosocial Adjustment Scale: assesses depression, anxiety and hostility
  3. Functioning: assesses the participant's ability to carry out activities of daily living
  4. Psychological Analysis: clinician's assessment of the psychological state of the participant.

Inclusion Criteria:

  • Participants must be between 15-24 years of age;
  • Participants must prefer to have the opportunity to join an educational program but not currently be enrolled in school;
  • A participant's total score on the Oxford scale must equal or exceed 30 AND
  • Participants must display at least one non-zero score on the functioning questions.

Exclusion Criteria:

  • Participant does not plan to reside in the Freetown urban area for the duration of the study (9 months from start date);
  • Participant fails to meet age requirements;
  • Participant is currently enrolled in school;
  • Participant is not in favor of joining an educational program;
  • Participant fails to meet Oxford psychosocial or functioning thresholds;
  • Participant is judged by clinical staff as:

    • Needing mental health treatment beyond the scope of the YRI
    • Otherwise not suitable for a group treatment setting
  • Participant displays the following:

    • Cognitive delays
    • Active suicidality
    • Psychosis
    • Risk of harm to themselves or others

Participants at risk of harm to themselves or others, as well as those requiring treatment beyond the scope of the YRI, will be referred to local mental health or social work treatment facilities as appropriate.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684488

Locations
Sierra Leone
CARITAS Freetown
Freetown, Sierra Leone
Sponsors and Collaborators
Harvard School of Public Health
CARITAS Freetown
International Rescue Committee
Harvard Medical School
Yale University
The City College of New York
Investigators
Principal Investigator: Theresa S Betancourt, ScD, MA Assistant Professor, Harvard School of Public Health
  More Information

Additional Information:
Publications:

Responsible Party: Theresa Betancourt, Assistant Professor, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01684488     History of Changes
Other Study ID Numbers: RPCGA-YRI-21003, USIP-008-10F
Study First Received: March 19, 2012
Last Updated: August 23, 2014
Health Authority: United States: Harvard School of Public Health Institutional Review Board
Sierra Leone: YRI Community Advisory Board
Sierra Leone: Scientific and Ethics Review Committee

Keywords provided by Harvard School of Public Health:
Depression/therapy;
Developing Countries;
Interpersonal Relations;
Life Change Events;
Psychotherapy, Group;
Resilience, Psychological;
Sierra Leone;
Survivors/psychology;
Social Adjustment;
Social Behavior;
War

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Disease
Stress, Psychological
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014