Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440460
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-20
First Post:
2024-05-28
Brief Title:
Intergenerational Study of War-Affected Youth
Sponsor:
Boston College
Organization:
Boston College
Study Overview
Official Title:
Social and Biological Mechanisms Driving the Intergenerational Impact of War on Child Mental Health Implications for Developing Family-Based Interventions
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISWAY
Brief Summary:
War-related violence is a leading driver of mental disorders and illness affecting children in low- and middle-income countries LMICs Parents exposed early in life to war-related violence and loss are at risk for mental health problems and may pass risks to their offspring The study posits that war-related trauma alters the stress-response circuitry in ways that endure into adulthood and affect the next generation This will be the first investigation in a 20-year longitudinal study to examine mechanisms that link parental war-related trauma exposure and subsequent mental health problems to risk for mental disorders in offspring This study will extend the first intergenerational study of war in Sub-Saharan Africa R01HD073349 to focus on children aged 7-24 born to war-affected parents Assessments of behavioral and biological indicators of the Research Domain Criteria RDoC-linked constructs of self-regulation and stress reactivity will be collected including autonomic nervous system reactivity inflammation and telomere length as well as sophisticated observations of parent-child interactions and synchrony These measures will be utilized to identify potentially modifiable risk and protective processes both to inform the development of screening tools to identify families at risk for poor child mental health and to be deployed as active ingredients of interventions to reduce transmission of mental health problems to children of war-affected parents
This follow-up study involves the following activities
1 Pilot to assess measure performance and field test study protocols
1 Translation and adaptation of newly selected measures
2 Pilot study of new child and adult measures with 36 caregivers and 60 children in a district of Sierra Leone unlinked to participants to test the feasibility and validity of new tools
2 Fifth wave of data collection from war-affected youth who are now parents and their children aged 7-24
1 Household tracking and re-enrollment of 145 households that were formerly enrolled in the Longitudinal Study of War-Affected Youth LSWAY T1 2002 T2 2004 T3 2008 T4 2016
2 Quantitative full sample and qualitative subsample data collection with 145 households who were enrolled in T4 LSWAY including war-affected youth who are now parents their intimate partners and their children aged 7-24
Through these activities the investigators will test three overarching hypotheses
1 Childhood war-related trauma exposure will be associated with mental difficulties anxiety depression post-traumatic stress disruptions of emotion regulation
2 Poor mental health in war-affected parents will be associated with emotional and behavioral disruptions in biological offspring
3 Risk and protective factors across the social ecology may serve as intervention targets to mitigate the effects of parental war-related trauma on behavioral disruptions and stress physiology both within and across generations
This follow-up study involves the following activities
1 Pilot to assess measure performance and field test study protocols
1 Translation and adaptation of newly selected measures
2 Pilot study of new child and adult measures with 36 caregivers and 60 children in a district of Sierra Leone unlinked to participants to test the feasibility and validity of new tools
2 Fifth wave of data collection from war-affected youth who are now parents and their children aged 7-24
1 Household tracking and re-enrollment of 145 households that were formerly enrolled in the Longitudinal Study of War-Affected Youth LSWAY T1 2002 T2 2004 T3 2008 T4 2016
2 Quantitative full sample and qualitative subsample data collection with 145 households who were enrolled in T4 LSWAY including war-affected youth who are now parents their intimate partners and their children aged 7-24
Through these activities the investigators will test three overarching hypotheses
1 Childhood war-related trauma exposure will be associated with mental difficulties anxiety depression post-traumatic stress disruptions of emotion regulation
2 Poor mental health in war-affected parents will be associated with emotional and behavioral disruptions in biological offspring
3 Risk and protective factors across the social ecology may serve as intervention targets to mitigate the effects of parental war-related trauma on behavioral disruptions and stress physiology both within and across generations
Detailed Description:
The Intergenerational Study of War-Affected Youth ISWAY entails a fifth wave of data collection in a 22-year study of war-affected youth in Sierra Leone LSWAY the first of its kind in Sub-Saharan Africa LSWAY findings drawn from four waves of data collection T12002 T2 2004 T3 2008 T4201617 indicate that a healthy transition to adulthood among war-affected youth was linked to engagement in prosocial behavior and community involvement while problems with hostility poor emotion regulation and social withdrawal created barriers to achieving healthy and productive lives Community stigma and poor family acceptance compounded these barriers Preliminary analyses of offspring of war-affected youth-first enrolled at T4-indicated that harsh paternal parenting was associated with offspring poor mental health and maternal parenting harsh and warm predicted offspring disruptions in emotion regulation and mental health The investigators theorize such associations are linked to biological mechanisms but research to date has been limited to cross-sectional data on the health and mental health of biological offspring
ISWAY will examine how social and biobehavioral mechanisms operate among war-affected parents to shape parenting and the mental health of offspring The studys guiding framework blends a biobehavioral and ecological model of risk and resilience with the Stress Adjustment ParadigmThe Multisystemic Model of Child Development holds that both behavioral and biological mechanisms are influenced by risk and protective factors at different levels of the social ecology and that exposure to trauma may lead to disruptions in individual stress reactivity and emotion regulation The Stress-Adjustment Paradigm posits that traumatic life events lead to individual outcomes that are shaped by risk and protective processes across the social ecology Taken together these theories propose that both past trauma and current social stressors eg underemployment stigma have implications for understanding the mechanisms linking past parental trauma to parent-child interactions and the mental health of subsequent generations Adult stress reactivity including ANS reactivity may manifest in similar ways among offspring Biological markers of inflammation and telomere length may also be linked in war-affected parents and their offspring An integrated model suggests that several important protective processes and resources may operate to mitigate these intergenerational disruptions such as social support and access to other attachment figures in the household who have strong self-regulation Helping parents who have experienced severe trauma build self-regulation skills and extending social support networks may be critical components of preventive interventions
ISWAY entails an enriched follow-up of the parents and their offspring focusing on the RDoC-related constructs that may underlie self-regulation negativepositive valence systems arousal systems social processes Collecting and analyzing both behavioral and biologicalphysiological data will deepen understanding of mechanisms that may contribute to increased risk of mental health difficulties in offspring This will be amplified by an exploration of modifiable risk and protective factors across the social ecology individual family and community levels to prioritize as intervention targets for addressing intergenerational risks to the mental health of offspring of war-affected parents
ISWAY will examine how social and biobehavioral mechanisms operate among war-affected parents to shape parenting and the mental health of offspring The studys guiding framework blends a biobehavioral and ecological model of risk and resilience with the Stress Adjustment ParadigmThe Multisystemic Model of Child Development holds that both behavioral and biological mechanisms are influenced by risk and protective factors at different levels of the social ecology and that exposure to trauma may lead to disruptions in individual stress reactivity and emotion regulation The Stress-Adjustment Paradigm posits that traumatic life events lead to individual outcomes that are shaped by risk and protective processes across the social ecology Taken together these theories propose that both past trauma and current social stressors eg underemployment stigma have implications for understanding the mechanisms linking past parental trauma to parent-child interactions and the mental health of subsequent generations Adult stress reactivity including ANS reactivity may manifest in similar ways among offspring Biological markers of inflammation and telomere length may also be linked in war-affected parents and their offspring An integrated model suggests that several important protective processes and resources may operate to mitigate these intergenerational disruptions such as social support and access to other attachment figures in the household who have strong self-regulation Helping parents who have experienced severe trauma build self-regulation skills and extending social support networks may be critical components of preventive interventions
ISWAY entails an enriched follow-up of the parents and their offspring focusing on the RDoC-related constructs that may underlie self-regulation negativepositive valence systems arousal systems social processes Collecting and analyzing both behavioral and biologicalphysiological data will deepen understanding of mechanisms that may contribute to increased risk of mental health difficulties in offspring This will be amplified by an exploration of modifiable risk and protective factors across the social ecology individual family and community levels to prioritize as intervention targets for addressing intergenerational risks to the mental health of offspring of war-affected parents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None