ClinicalTrials.gg
CompletedNCT01684488YRIUpdated May 31, 2018

Trial of the Youth Readiness Intervention

An interventional study of YRI and EducAid educational programming in Anxiety Disorder/Anxiety State, Depressive Disorder/Psychology and Social Problems/Psychology, sponsored by Boston College. Completed at 1 site in Sierra Leone. Open to participants aged 15 Years to 24 Years. Per ClinicalTrials.gov, last updated 2018-05-31.

Sponsored by Boston College · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
443
Allocation
Randomized
Ages
15 Years to 24 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Anxiety Disorder/Anxiety State
  • Depressive Disorder/Psychology
  • Social Problems/Psychology
  • Stress, Psychological
  • Violence, Non-accidental

Keywords

  • Depression/therapy;
  • Developing Countries;
  • Interpersonal Relations;
  • Life Change Events;
  • Psychotherapy, Group;
  • Resilience, Psychological;
  • Sierra Leone;
  • Survivors/psychology;
  • Social Adjustment;
  • Social Behavior;
  • War
03

In context

Anxiety Disorders

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 443 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Boston College is the lead sponsor of 38 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
443 participants (actual)

Study arms

  • 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

  • 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: YRI · Other: EducAid educational programming

  • 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: YRI · Other: EducAid educational programming

Interventions

  • BehavioralYRI

    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.

    Also known as: Youth Readiness Intervention

  • OtherEducAid 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.

06

What researchers measure

Primary outcomes

  1. Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0)

    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.

    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

Secondary outcomes

  1. Change in scores on the Youth Assessment Battery

    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.

    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

07

Study locations

1 site
  • CARITAS Freetown
    Freetown, Sierra Leone
08

References and documents

Publications

  • Betancourt TS, Borisova II, de la Soudiere M, Williamson J. Sierra Leone's child soldiers: war exposures and mental health problems by gender. J Adolesc Health. 2011 Jul;49(1):21-8. doi: 10.1016/j.jadohealth.2010.09.021. Epub 2010 Dec 24. PubMed 21700152 ↗
  • Betancourt TS. Attending to the mental health of war-affected children: the need for longitudinal and developmental research perspectives. J Am Acad Child Adolesc Psychiatry. 2011 Apr;50(4):323-5. doi: 10.1016/j.jaac.2011.01.008. No abstract available. PubMed 21421171 ↗
  • Betancourt TS, Borisova II, Williams TP, Brennan RT, Whitfield TH, de la Soudiere M, Williamson J, Gilman SE. Sierra Leone's former child soldiers: a follow-up study of psychosocial adjustment and community reintegration. Child Dev. 2010 Jul-Aug;81(4):1077-95. doi: 10.1111/j.1467-8624.2010.01455.x. PubMed 20636683 ↗
  • Betancourt TS, Brennan RT, Rubin-Smith J, Fitzmaurice GM, Gilman SE. Sierra Leone's former child soldiers: a longitudinal study of risk, protective factors, and mental health. J Am Acad Child Adolesc Psychiatry. 2010 Jun;49(6):606-15. doi: 10.1016/j.jaac.2010.03.008. Epub 2010 May 1. PubMed 20494270 ↗
  • Betancourt TS, Agnew-Blais J, Gilman SE, Williams DR, Ellis BH. Past horrors, present struggles: the role of stigma in the association between war experiences and psychosocial adjustment among former child soldiers in Sierra Leone. Soc Sci Med. 2010 Jan;70(1):17-26. doi: 10.1016/j.socscimed.2009.09.038. Epub 2009 Oct 28. PubMed 19875215 ↗
  • Betancourt TS, Simmons S, Borisova I, Brewer SE, Iweala U, Soudiere MD. High Hopes, Grim Reality: Reintegration and the Education of Former Child Soldiers in Sierra Leone. Comp Educ Rev. 2008 Nov 1;52(4):565-587. doi: 10.1086/591298. No abstract available. PubMed 19337570 ↗
  • Betancourt TS, Bass J, Borisova I, Neugebauer R, Speelman L, Onyango G, Bolton P. Assessing local instrument reliability and validity: a field-based example from northern Uganda. Soc Psychiatry Psychiatr Epidemiol. 2009 Aug;44(8):685-92. doi: 10.1007/s00127-008-0475-1. Epub 2009 Jan 22. PubMed 19165403 ↗
  • Verdeli H, Clougherty K, Onyango G, Lewandowski E, Speelman L, Betancourt TS, Neugebauer R, Stein TR, Bolton P. Group Interpersonal Psychotherapy for depressed youth in IDP camps in Northern Uganda: adaptation and training. Child Adolesc Psychiatr Clin N Am. 2008 Jul;17(3):605-24, ix. doi: 10.1016/j.chc.2008.03.002. PubMed 18558315 ↗
  • Bolton P, Bass J, Betancourt T, Speelman L, Onyango G, Clougherty KF, Neugebauer R, Murray L, Verdeli H. Interventions for depression symptoms among adolescent survivors of war and displacement in northern Uganda: a randomized controlled trial. JAMA. 2007 Aug 1;298(5):519-27. doi: 10.1001/jama.298.5.519. PubMed 17666672 ↗
  • Betancourt TS, Speelman L, Onyango G, Bolton P. A qualitative study of mental health problems among children displaced by war in northern Uganda. Transcult Psychiatry. 2009 Jun;46(2):238-56. doi: 10.1177/1363461509105815. PubMed 19541749 ↗
  • Betancourt TS, Khan KT. The mental health of children affected by armed conflict: protective processes and pathways to resilience. Int Rev Psychiatry. 2008 Jun;20(3):317-28. doi: 10.1080/09540260802090363. PubMed 18569183 ↗
  • Betancourt TS. Child soldiers: reintegration, pathways to recovery, and reflections from the field. J Dev Behav Pediatr. 2008 Apr;29(2):138-41. doi: 10.1097/DBP.0b013e31816be946. No abstract available. PubMed 18408537 ↗
  • Betancourt TS, Williams T. Building an evidence base on mental health interventions for children affected by armed conflict. Intervention (Amstelveen). 2008;6(1):39-56. doi: 10.1097/WTF.0b013e3282f761ff. PubMed 19997531 ↗
  • Betancourt TS, McBain R, Newnham EA, Akinsulure-Smith AM, Brennan RT, Weisz JR, Hansen NB. A behavioral intervention for war-affected youth in Sierra Leone: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Dec;53(12):1288-97. doi: 10.1016/j.jaac.2014.09.011. Epub 2014 Oct 2. PubMed 25457927 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2012, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2012
First posted
Sep 13, 2012
Start
Apr 2012
Primary completionActual
Dec 2014
CompletionActual
Dec 2014
Last update
May 31, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01684488
Lead sponsor
Boston College
Collaborators
Caritas Freetown, International Rescue Committee, Harvard Medical School (HMS and HSDM), Yale University, The City College of New York
Responsible party
Theresa Betancourt (Salem Professor in Global Practice, Boston College) — Principal investigator
First posted
Sep 13, 2012
Start date
Apr 2012
Primary completion
Dec 2014
Completion
Dec 2014
Last update
May 31, 2018

Study contacts

Theresa S Betancourt, ScD, MA
principal investigator · Boston College

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion