Clinical trial NCT06440460: Intergenerational Study of War-Affected Youth
Official title: Social and Biological Mechanisms Driving the Intergenerational Impact of War on Child Mental Health: Implications for Developing Family-Based Interventions
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Anxiety Disorders
Anxiety State
Depressive Disorder
Mood Disorders
Trauma and Stressor Related Disorders
Social Skills
Violence, Non-accidental
Keywords: Early Child Development
Sierra Leone
Observational Study
Longitudinal
Emotion Regulation
Self Regulation
Mental Health
Stress
Trauma
Quality of Life
Stress Biomarkers
Biological Embedding
Parenting
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: University of Makeni
name: Caritas Freetown
name: Tulane University
name: Kenema Government Hospital
First posted: 2024-06-03
Enrollment: 804
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of participants who were formerly enrolled in T4 of LSWAY, including index subjects (i.e., war-affected youth), their caregivers, and biological offspring who meet the eligibility criteria. In addition, focus group participants, who were not part of the LSWAY cohort from prior study waves, will be recruited from the 5 largest districts in which LSWAY participants reside. These participants will be sampled in order to understand community experiences regarding the social context of parenting in Sierra Leone, including challenges and perceptions of social norms and their effect on everyday life in Sierra Leone.

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.

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 (T1:2002, T2: 2004, T3: 2008, T4:2016/17) 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 study's guiding framework blends a biobehavioral and ecological model of risk and resilience with the Stress Adjustment Paradigm.The 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 (e.g., 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 (negative/positive valence systems, arousal systems, social processes). Collecting and analyzing both behavioral and biological/physiological 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.

Eligibility criteria: Inclusion Criteria:

* being a war-affected young adult (referred to as the index participant) previously interviewed at one or more waves of the Longitudinal Study of War Affected Youth (LSWAY) who still resides in Sierra Leone
* being a cohabitating intimate partner of the index participant; or (c) being a cohabitating biological child (aged 7-24) of the index participant. Exclusion criteria are (a) not being sampled in a prior LSWAY wave
* being a cohabitating biological child (aged 7-24) of the index participant

Exclusion Criteria:

* not being sampled in a prior LSWAY wave
* not being a biological child or intimate partner of the index cohort participant
* being in acute crisis (active suicidality or psychosis)

Primary outcomes:
measure: Hopkins Symptom Checklist (HSCL)
timeFrame: May-December 2024
measure: Center for Epidemiological Studies Depression Scale-Child (CESD-Child)
timeFrame: May-December 2024
measure: UCLA PTSD Reaction Index-Revised (UCLA PTSD-RI)
timeFrame: May-December 2024
measure: Child Behavior Checklist (CBCL)
timeFrame: May-December 2024
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: May-December 2024
measure: Oxford Measure of Psychosocial Adjustment (OMPA)
timeFrame: May-December 2024
measure: Rapid Assessment of. Cognitive and Emotional Regulation (RACER)
timeFrame: May-December 2024
measure: Kaufman Assessment Battery for Children
timeFrame: May-December 2024
measure: SWAY Parenting
timeFrame: May-December 2024
measure: Adapted UNICEF Multiple Indicator Cluster Survey Child Discipline Module
timeFrame: May-December 2024
measure: Parenting Acceptance and Rejection Questionnaire (PARQ)
timeFrame: May-December 2024
measure: Coding Interactive Behavior
timeFrame: May-December 2024
measure: Early Grade Reading Assessment Early Grade Reading Assessment
timeFrame: May-December 2024
measure: Early Grade Math Assessment
timeFrame: May-December 2024
measure: Autonomic Stress Reactivity
timeFrame: May-December 2024
measure: Telomere Length
timeFrame: May-December 2024
measure: Inflammation
timeFrame: May-December 2024
measure: Post-War Adversities Scale
timeFrame: May-December 2024
measure: Perceived Stress Scale (PSS)
timeFrame: May-December 2024
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: May-December 2024
Secondary outcomes:
measure: Brief COPE Scale
timeFrame: May-December 2024
measure: Normative Beliefs about Aggression Scale (NBA)
timeFrame: May-December 2024
measure: Post-Traumatic Growth Inventory (PTGI)
timeFrame: May-December 2024
measure: Adapted Youth Risk Behavior Survey
timeFrame: May-December 2024
measure: WHO Disability Adjustment Scale (WHODAS)
timeFrame: May-December 2024
measure: Child Rating Scale (CRS)
timeFrame: May-December 2024
measure: Demographic and Health Survey (DHS) - Intimate Partner Violence (IPV)
timeFrame: May-December 2024
measure: Dyadic Adjustment Scale (DAS)
timeFrame: May-December 2024
measure: Demographic and Health Survey (DHS) Sierra Leone Household Module
timeFrame: May-December 2024
measure: Perceived Community Acceptance (PCA)
timeFrame: May-December 2024
measure: Collective Efficacy Scale (CES)
timeFrame: May-December 2024
measure: Everyday Discrimination Scale (EDS)
timeFrame: May-December 2024
measure: Inventory of Socially Supportive Behaviors (ISSB)
timeFrame: May-December 2024
measure: Gender Equitable Men scale (GEM)
timeFrame: May-December 2024
Other outcomes:
Locations:
city: Freetown
country: Sierra Leone
facility: Caritas Freetown
Study officials:
affiliation: Boston College
name: Theresa S Betancourt
role: PRINCIPAL_INVESTIGATOR
References: