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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06440460
Other study ID # 22.115.01
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 27, 2024
Est. completion date November 30, 2026

Study information

Verified date June 2024
Source Boston College
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 804
Est. completion date November 30, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers No
Gender All
Age group 7 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Sierra Leone Caritas Freetown Freetown

Sponsors (5)

Lead Sponsor Collaborator
Boston College Caritas Freetown, Kenema Government Hospital, Tulane University, University of Makeni

Country where clinical trial is conducted

Sierra Leone, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hopkins Symptom Checklist (HSCL) The HSCL is a diagnostic tool for depression and anxiety in caregivers and consists of 25 items, including 10 items for anxiety symptoms and 15 items for depression symptoms. Response options are Not at All (1), A Little (2), Quite a Bit (3), and Extremely (4) with higher scores indicating more symptoms. May-December 2024
Primary Center for Epidemiological Studies Depression Scale-Child (CESD-Child) The CESD-Child is a diagnostic tool for depression in children. Caregiver and child self-report versions include 20 items with response options including Never (0), A little (1), Sometimes (2), and Often (A Lot) (3) with higher values indicating more symptoms. May-December 2024
Primary UCLA PTSD Reaction Index-Revised (UCLA PTSD-RI) The UCLA PSTD-RI is a diagnostic tool for post-traumatic stress disorder. An adult self-report version includes 23 items assessing trauma history, scored according to whether the event occurred or not (0 = No, 1 = Yes), and 12 items on PTSD symptoms with response options including Never (0), Sometimes (1), and Often (2) with higher values indicating more symptoms. A child self-report version includes 14 items assessing trauma history, scored according to whether the event occurred or not (0 = No, 1 = Yes), and 11 items on PTSD symptoms with response options including Never (0), Sometimes (1), and Often (2) with higher values indicating more symptoms. May-December 2024
Primary Child Behavior Checklist (CBCL) The CBCL includes child self-report and caregiver report on child's internalizing and/or externalizing behavior. The caregiver report includes 118 items with response options including Not True (0), Somewhat or Sometimes True (1), and Very True or Often True (2). Scores are summed within 8 syndrome scales (Withdrawn, Somatic Complaints, Anxious/Depressed, Social Problems, Thought Problems, Attention Problems, Delinquent Behavior, and Aggressive Behavior) with higher scores indicating more symptoms. The child self-report includes 102 items with the same response options and subscales as the caregiver version. Higher scores indicate more symptoms. May-December 2024
Primary Difficulties in Emotion Regulation Scale (DERS) The DERS includes caregiver self-report and child self-report on emotion regulation. There are 36 items that measure six subscales: nonacceptance of emotional responses; difficulty engaging in goal-directed behavior; impulse control difficulties; lack of emotional awareness; limited access to emotion regulation strategies; lack of emotional clarity. Response options are Almost Never (1), Sometimes (2), About Half the Time (3), Most of the Time (4), and Almost Always (5) with higher scores indicating greater difficulties in emotion regulation. May-December 2024
Primary Oxford Measure of Psychosocial Adjustment (OMPA) The OMPA includes child self-report and caregiver report on child of externalizing, internalizing, and prosocial attitudes and behaviors. The full scale includes 53 items measuring four subscales: anxiety and depression; hostility; pro-social behavior; and confidence. Response options are Never (1), Hardly (2), Sometimes (3), and Always (4) with higher scores indicating more symptoms. May-December 2024
Primary Rapid Assessment of. Cognitive and Emotional Regulation (RACER) Observation of child and caregiver cognitive functioning May-December 2024
Primary Kaufman Assessment Battery for Children Observation of child's May-December 2024
Primary SWAY Parenting The SWAY Parenting scale includes caregiver report on family information such as the number of biological and non-biological children, numbers of children, and history of pregnancy, followed by 15 Likert-scale items that ask about caregiving behaviors (e.g., time spent playing with child, reading to child, telling stories, etc.). Response options are Never (0), Sometimes (1), Often (2), and Always (3) with higher scores indicating more engagement in caregiving behaviors. May-December 2024
Primary Adapted UNICEF Multiple Indicator Cluster Survey Child Discipline Module Caregiver self-report of child discipline practices and behaviors May-December 2024
Primary Parenting Acceptance and Rejection Questionnaire (PARQ) The PARQ Short Form includes caregiver self-report and child report on caregiver versions with 23 items and four subscales (warmth/affection, hostility/aggression, indifference/neglect, and undifferentiated rejection). Response options are Almost Never True (1), Rarely True (2), Sometimes True (3), and Almost Always True (4) with higher scores indicating more frequent behaviors. May-December 2024
Primary Coding Interactive Behavior Coding system for observation of caregiver-child interactions May-December 2024
Primary Early Grade Reading Assessment Early Grade Reading Assessment Observation of child's early literacy skills May-December 2024
Primary Early Grade Math Assessment Observation of child's early numeracy skills May-December 2024
Primary Autonomic Stress Reactivity Measure of caregiver and child's autonomic response to stress via respiratory sinus arrhythmia (RSA) May-December 2024
Primary Telomere Length Measure of caregiver and child's telomere length May-December 2024
Primary Inflammation Measure of caregiver and child's inflammatory markers (e.g., C-reactive protein) May-December 2024
Primary Post-War Adversities Scale The Post-War Adversities Scale is an adult self-report scale that includes 18 items asking about daily hardships within the past three months (e.g., inadequate living accommodations, eviction, serious conflicts, etc) and 11 items asking about daily hardships within the past 12 months (e.g., being robbed, very ill, deaths, financial crisis, etc.). Response options are No (0) and Yes (1). Higher scores indicate more adversities. May-December 2024
Primary Perceived Stress Scale (PSS) The PSS is an adult self-report scale with 10 items asking about perceptions of stressful feelings (e.g., unable to cope, feeling nervous and stressed, being angered, etc.). Response options include Never (0), Almost Never (1), Sometimes (2), Fairly Often (3), and Very Often (4) with higher scores indicating more feelings of distress. May-December 2024
Primary Childhood Trauma Questionnaire (CTQ) The CTQ is an adult self-report scale with five subscales including emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect. Response options include Never (0), Hardly (1), Sometimes (2), and Always (3) with higher scores indicating more abuse or neglect. May-December 2024
Secondary Brief COPE Scale The Brief COPE is an adult self-report scale that includes 14 subscales with two items each for a total of 28 items. Subscales include: self-distraction; active coping; denial; substance use; use of emotional support; use of instrumental support; behavioral disengagement; venting; positive reframing; planning; humor; acceptance; religion; and self-blame. Response options include Not at All (1), A Little (2), Some (3), and A Lot (4) with higher scores indicating more endorsement of the coping style. May-December 2024
Secondary Normative Beliefs about Aggression Scale (NBA) The NBA is a 20-item scale that can be used with children, adolescents, and adults to measure perceptions of how acceptable it is to behave aggressively under different conditions. Response options include It's Really Wrong (0), It's Sort of Wrong (1), It's Sort of OK (2), and It's Perfectly OK (3) with higher scores indicating a more accepting disposition toward aggression. May-December 2024
Secondary Post-Traumatic Growth Inventory (PTGI) The PTGI is a caregiver self-report scale with 21 items and five subscales including relating to others, new possibilities, personal strength, spiritual change, and appreciation of life. Response options include: I did not experience this change (1), I experienced this change to a very small degree (2), I experienced this change to a small degree (3), I experienced this change to a moderate degree (4), I experienced this change to a great degree (5), and I experienced this change to a very great degree (6). Higher scores indicate more post-traumatic growth. May-December 2024
Secondary Adapted Youth Risk Behavior Survey Child and caregiver self-report of risk behaviors May-December 2024
Secondary WHO Disability Adjustment Scale (WHODAS) The WHODAS is an adult and child self-report scale that includes 12 items asking about difficulties with functioning within the past 30 days. Response options include None (0), Mild (1), Moderate (2), Severe (3), and Extreme or Can't Do (4) with higher scores indicating more difficulties. May-December 2024
Secondary Child Rating Scale (CRS) The CRS is a child self-report scale that includes 40 items and four subscales including rule compliance/acting out, anxiety/withdrawal, interpersonal social skills, and self-confidence. Response options are Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) with higher scores indicating more endorsement of the trait. May-December 2024
Secondary Demographic and Health Survey (DHS) - Intimate Partner Violence (IPV) The IPV scale is an adult self-report scale of intimate partner violence perpetration and victimization. The scale includes 20 perpetration items and 20 victimization items on emotional, physical, and sexual abuse within the previous three months. Response options are This Has Never Happened (0), Once in the Past Three Months (1), Twice in the Past Three Months (2), 3 to 5 Times in the Past Three Months (3), 6 to 10 Times in the Past Three Months (4), 11-20 times in the Past Three Months (5), More than 20 Times in the Past Three Months (6), Not in the Three Months, but It Did Happen Before (7). The questionnaire is scaled such that higher values indicate more intimate partner violence. May-December 2024
Secondary Dyadic Adjustment Scale (DAS) The DAS is an adult self-report measure of relationship quality with 32 items and four subscales including dyadic consensus, dyadic satisfaction, dyadic cohesion, and affectional expression. The scale is scored such that higher scores indicate more positive characteristics within each subscale. May-December 2024
Secondary Demographic and Health Survey (DHS) Sierra Leone Household Module Caregiver and adult child report on demographic and household information May-December 2024
Secondary Perceived Community Acceptance (PCA) The PCA scale is an adult self-report scale that includes 12 items on perceptions about one's acceptance within the community. Response options are Not True (1), Sometimes/Somewhat True (2), and Very True (3) with higher scores indicating more community acceptance. May-December 2024
Secondary Collective Efficacy Scale (CES) The CES is an adult self-report measure of perceptions of cohesion and mutual trust within the community. The scale is scored to measure two dimensions, collective efficacy and community disorder, with higher scores indicating more endorsement of the subscale characteristic. May-December 2024
Secondary Everyday Discrimination Scale (EDS) The EDS is an adult self-report measure of interpersonal discrimination that is either chronic or episodic. Response options are Never (0), Sometimes (1), and Always (2) with higher scores indicating more experiences of discrimination. May-December 2024
Secondary Inventory of Socially Supportive Behaviors (ISSB) The ISSB is an adult and child self-report measure of social support. The version used in this study is adapted to the local context and consists of 25 Likert-style items asking about whether the participant had relationships with people who provided various kinds of social support within the previous month. Response options include It Never Happened (1), It Happened One or Two Times Per Month (2), It Happened One Time Per Week (3), It Happened Several Times Per Week (4), It Happened Almost Every Day (5), with higher scores indicating more social support. May-December 2024
Secondary Gender Equitable Men scale (GEM) The GEM Short Form is an adult scale measuring attitudes about gender roles with 9 items. Response options include Do Not Agree (0), Partially Agree (1), and Agree (2) with higher scores indicating more inequitable beliefs about gender roles. May-December 2024
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