An observational study in Anxiety Disorders, Anxiety State and Depressive Disorder, sponsored by Boston College. Active, not recruiting at 1 site in Sierra Leone. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Boston College · Observational
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:
Pilot to assess measure performance and field test study protocols.
Fifth wave of data collection from war-affected youth who are now parents and their children aged 7-24.
Through these activities, the investigators will test three overarching hypotheses:
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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 804 is above the median of 168 across 977 observational studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Boston College is the lead sponsor of 38 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
Rapid Assessment of. Cognitive and Emotional Regulation (RACER)
Observation of child and caregiver cognitive functioning
Time frame: May-December 2024
Kaufman Assessment Battery for Children
Observation of child's
Time frame: May-December 2024
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.
Time frame: May-December 2024
Adapted UNICEF Multiple Indicator Cluster Survey Child Discipline Module
Caregiver self-report of child discipline practices and behaviors
Time frame: May-December 2024
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.
Time frame: May-December 2024
Coding Interactive Behavior
Coding system for observation of caregiver-child interactions
Time frame: May-December 2024
Early Grade Reading Assessment Early Grade Reading Assessment
Observation of child's early literacy skills
Time frame: May-December 2024
Early Grade Math Assessment
Observation of child's early numeracy skills
Time frame: May-December 2024
Autonomic Stress Reactivity
Measure of caregiver and child's autonomic response to stress via respiratory sinus arrhythmia (RSA)
Time frame: May-December 2024
Telomere Length
Measure of caregiver and child's telomere length
Time frame: May-December 2024
Inflammation
Measure of caregiver and child's inflammatory markers (e.g., C-reactive protein)
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
Adapted Youth Risk Behavior Survey
Child and caregiver self-report of risk behaviors
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
Demographic and Health Survey (DHS) Sierra Leone Household Module
Caregiver and adult child report on demographic and household information
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
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.
Time frame: May-December 2024
Plan to share: No
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Ran from May 2024 to primary completion in Jun 2026, 24 months.
Of 411 non-industry observational studies under Anxiety Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 49. This study's 24 months is above that.
Counting every sponsor, half of 439 studies reached it within 19 months; a quarter within 6 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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