Depressive Disorder Clinical Trial
Official title:
A Feasibility Trial of the Youth Readiness Intervention: A Group Psychosocial Intervention for War-affected Youth in Sierra Leone
Verified date | April 2019 |
Source | Harvard School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 24 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Sierra Leone | CARITAS Freetown | Freetown |
Lead Sponsor | Collaborator |
---|---|
Harvard School of Public Health | Caritas Freetown, McGill University, The City College of New York, Yale University |
Sierra Leone,
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. — View Citation
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. — View Citation
Betancourt TS, Borisova II, de la Soudière 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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Betancourt TS, Simmons S, Borisova I, Brewer SE, Iweala U, Soudière 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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