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

NCT02128568 | Withdrawn DMC

• 1 other identifier: RPCGA-YRI-21003-Bio
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorder; Depressive Disorder; Social Problems; 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

Outcome Measures

Primary Outcomes (3)

• Collection of epigenetic biomarker samples

  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.

  Administered at 2 timepoints: (1) baseline; (2) within 15 days of YRI completion

• 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 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.

  Administered at 2 timepoints: (1) baseline; (2) within 15 days of YRI completion

• 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.

  Administered at 2 timepoints: (1) baseline; (2) within 15 days of YRI completion

Study Arms (2)

Waitlist + YRI only

ACTIVE COMPARATOR

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

YRI only

EXPERIMENTAL

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

Behavioral: Youth Readiness Intervention

Interventions

Youth Readiness Intervention BEHAVIORAL

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.

Waitlist + YRI only; YRI only

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Caritas Freetown: collaborator
• McGill University: collaborator
• Yale University: collaborator
• The City College of New York: collaborator

Study Sites (1)

CARITAS Freetown

Freetown, Sierra Leone

Location

Related Publications (13)

• 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.

  PMID: 21700152 BACKGROUND

• 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.

  PMID: 21421171 BACKGROUND

• 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.

  PMID: 20636683 BACKGROUND

• 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.

  PMID: 20494270 BACKGROUND

• 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.

  PMID: 19875215 BACKGROUND

• 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.

  PMID: 19337570 BACKGROUND

• 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.

  PMID: 19165403 BACKGROUND

• 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.

  PMID: 18558315 BACKGROUND

• 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.

  PMID: 17666672 BACKGROUND

• 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.

  PMID: 19541749 BACKGROUND

• 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.

  PMID: 18569183 BACKGROUND

• 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.

  PMID: 18408537 BACKGROUND

• 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.

  PMID: 19997531 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Stress, Psychological; Depression; Social Adjustment; Social Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Theresa S Betancourt, ScD, MA

  Department of Global Health and Population, Harvard School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Child Health and Human Rights

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

SI (1)