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Sub-Trial of the Youth Readiness Intervention (YRI): Treatment of Control Group and Addition of Stress Biomarkers

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ClinicalTrials.gov Identifier: NCT02128568
Recruitment Status : Withdrawn (Did not receive funding)
First Posted : May 1, 2014
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
Caritas Freetown
McGill University
Yale University
The City College of New York
Information provided by (Responsible Party):
Theresa Betancourt, Harvard School of Public Health

Brief Summary:

This research is a continuation of the Youth Readiness Intervention (YRI) randomized clinical trial by adding additional pre and post intervention data collection upon treatment of the control group (N=222) with the intervention which was proven effective in the larger trial. The overall research has investigated whether participation in the YRI intervention will improve emotional regulation, prosocial attitudes/behavior, social support and daily and functioning among war-affected 15-24 year olds in Sierra Leone. In this sub-study which will involve treatment of the control group with the effective YRI intervention, the investigators will add an additional measure of self-regulation as observed via DNA methylation in buccal cells collected via cheek swabs. As before, after the YRI intervention, youth will be offered a free educational opportunity at the EducAid program in Freetown or in one of its upline/provincial sites. This stage of the research, as in the treatment with the main group, will test whether youth enrolled in the YRI psychosocial intervention go on to demonstrate improved attendance and behavior in a subsidized education program. In the previous phase of the trial, the investigators did observe significant effects for the YRI intervention and evidence that the program is indeed effective. For instance, post-intervention, YRI youth reported greater improvements in emotion regulation (β=0.109, 95%CI 0.026 to 0.191, δ=0.31), prosocial attitudes/behaviors (β=0.149, 95%CI 0.057 to 0.240, δ=0.38), and social support (β=0.119, 95%CI 0.009 to 0.229, δ=0.26) than controls, and greater reductions in functional impairments (β= -0.175, 95%CI -0.299 to -0.050, δ= -0.35). Differences in symptoms were non-significant at six-month follow-up for the full sample; moderator analyses showed that, for individuals in the top quartile of baseline symptoms, YRI youth had greater improvements in emotion regulation and social support than controls. At eight-month follow-up, teachers reported that YRI participants were 8.9 times more likely to be in school (28.8% v. 4.7%) and showed better attendance (β=3.553, 95%CI 0.989 to 6.118, OR=34.93) and academic performance (β= -0.954, 95%CI -1.807 to -0.102, δ= -1.31).

In this final phase of the trial as the investigators treat the wait list control group, the investigators will test whether intervention effects observed in self-report data on improved emotion-regulation are also upheld in biomarker data. Thus, the investigators will now provide YRI treatment to the wait list control group and employ the use of biomarkers as a measure of the intervention's effectiveness. The objective of the study will be to assess whether DNA methylation (collected via cheek swabs of buccal cells) is associated with changes in emotion regulation pre- and post- intervention. The aim is to test the hypothesis that the YRI is associated with improvements emotion-regulation evidence both in self-report data on emotion-regulation and in buccal cell DNA methylation. This study will add to the evidence base for effective, culturally sensitive mental health services for youth and young adults affected by war and other forms of adversity.


Condition or disease Intervention/treatment Phase
Anxiety Disorder Depressive Disorder Social Problems Stress, Psychological Violence, Non-accidental Behavioral: Youth Readiness Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Waitlist + YRI only
Participants will complete the assessment and collection of biomarkers and be placed on a waitlist. Once the trial of the first arm has been concluded, participants complete another round of assessments and are offered the YRI sessions. The epigenetic biomarkers collected will be compared with the experimental arm.
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 12 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.

Experimental: YRI only
Immediately following assessment and collection of biomarkers, participants will be offered the YRI sessions.
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 12 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.




Primary Outcome Measures :
  1. Collection of epigenetic biomarker samples [ Time Frame: Administered at 2 timepoints: (1) baseline; (2) within 15 days of YRI completion ]
    Description: Emotion regulation will be measured via epigenetic biomarkers, specifically DNA methylation of buccal cells collected via cheek swabs. A buccal cheek swab allows for rapid and consistent isolation of genomic DNA and is a convenient method for the acquiring of a DNA sample to examine methylation. DNA will be extracted for the purpose of identifying epigenetic marks (DNA methylation) across the genome and for sequence analysis of specific genomic regions. The DNA methylation data will be analyzed in relation to trauma history and intervention receipt, examining potential epigenetic changes associated with functionally relevant outcomes. Analysis of survey data will use inferential statistics to measure changes in constructs of relevance to the YRI, such as emotional regulation and perceived emotional, instrumental and informational support from others, community acceptance, and interpersonal skills.

  2. 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 2 timepoints: (1) baseline; (2) within 15 days of YRI completion ]
    Primary outcomes of interest include the DERS (Disturbances in Emotion Regulation Scale), psychological distress (combined internalizing and externalizing problem scores) and changes in pro-social behaviors 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). All measures are incorporated within the study's comprehensive Youth Assessment Battery.

  3. Change in scores on the Youth Assessment Battery [ Time Frame: Administered at 2 timepoints: (1) baseline; (2) within 15 days of YRI completion ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

The control group of the YRI are the only eligible participants to complete the biomarkers .They were screened based on the eligibility requirements for the YRI, 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 internalizing and externalizing problems in war affected youth and was developed and validated for use in Sierra Leone
  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 from the control group of the YRI study; the inclusion criteria described below.

    • Participants must be between 15-24 years of age;
    • Participants must be school-intending at time of enrollment (2012)
    • 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 functional impairment 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 fails to meet Oxford psychosocial or functioning thresholds;
  • Participant is judged by clinical staff as:

    o Needing mental health treatment beyond the scope of the YRI

  • Otherwise not suitable for a cheek swab data collection.
  • Participant displays the following:

    • Severe cognitive delays which preclude comprehension and ability to respond to items on the Youth Assessment Battery
    • Active suicidality
    • Psychosis
    • Risk of harm to themselves or others

Participants at risk of harm to themselves or others will be referred to local mental health or social work treatment facilities as appropriate.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128568


Locations
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Sierra Leone
CARITAS Freetown
Freetown, Sierra Leone
Sponsors and Collaborators
Harvard School of Public Health
Caritas Freetown
McGill University
Yale University
The City College of New York
Investigators
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Principal Investigator: Theresa S Betancourt, ScD, MA Department of Global Health and Population, Harvard School of Public Health

Publications:

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Responsible Party: Theresa Betancourt, Associate Professor of Child Health and Human Rights, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT02128568     History of Changes
Other Study ID Numbers: RPCGA-YRI-21003-Bio
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

Keywords provided by Theresa Betancourt, 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:
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Disease
Depressive Disorder
Depression
Anxiety Disorders
Stress, Psychological
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms