Anxiety DisordersISWAYNCT06440460
Intergenerational Study of War-Affected Youth
An observational study of Anxiety Disorders and Anxiety State, run by Boston College at 1 site in Sierra Leone.
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Anxiety Disorders, Anxiety State, Depressive Disorder
- How many people
- 804 participants
- Where
- 1 siteSierra Leone
- Study dates
- 27 May 2024to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social and Biological Mechanisms Driving the Intergenerational Impact of War on Child Mental Health: Implications for Developing Family-Based Interventions
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:
Read more
- Pilot to assess measure performance and field test study protocols.
- Translation and adaptation of newly selected measures
- 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.
- Fifth wave of data collection from war-affected youth who are now parents and their children aged 7-24.
- 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).
- 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:
- Childhood war-related trauma exposure will be associated with mental difficulties (anxiety, depression, post-traumatic stress, disruptions of emotion regulation).
- Poor mental health in war-affected parents will be associated with emotional and behavioral disruptions in biological offspring.
- 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.
Read the 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.
- Conditions
- Anxiety Disorders, Anxiety State, Depressive Disorder, Mood Disorders, Trauma and Stressor Related Disorders, Social Skills
- 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
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Mood Disorders, Trauma and Stressor Related Disorders, Social Skills, Emotional Regulation, Self-Control, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: May-December 2024
Rapid Assessment of. Cognitive and Emotional Regulation (RACER)
Observation of child and caregiver cognitive functioning
Measured: May-December 2024
Kaufman Assessment Battery for Children
Observation of child's
Measured: 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.
Measured: May-December 2024
Adapted UNICEF Multiple Indicator Cluster Survey Child Discipline Module
Caregiver self-report of child discipline practices and behaviors
Measured: 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.
Measured: May-December 2024
Coding Interactive Behavior
Coding system for observation of caregiver-child interactions
Measured: May-December 2024
Early Grade Reading Assessment Early Grade Reading Assessment
Observation of child's early literacy skills
Measured: May-December 2024
Early Grade Math Assessment
Observation of child's early numeracy skills
Measured: May-December 2024
Autonomic Stress Reactivity
Measure of caregiver and child's autonomic response to stress via respiratory sinus arrhythmia (RSA)
Measured: May-December 2024
Telomere Length
Measure of caregiver and child's telomere length
Measured: May-December 2024
Inflammation
Measure of caregiver and child's inflammatory markers (e.g., C-reactive protein)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: May-December 2024
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: May-December 2024
Adapted Youth Risk Behavior Survey
Child and caregiver self-report of risk behaviors
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: May-December 2024
Demographic and Health Survey (DHS) Sierra Leone Household Module
Caregiver and adult child report on demographic and household information
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: May-December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start27 May 2024
- Primary completion1 Jun 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 804 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- University of Makeni, Caritas Freetown, Tulane University, Kenema Government Hospital
- Responsible party
- Principal investigator, Theresa Betancourt, Boston College
- Investigators
- Theresa S Betancourt, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440460
- Sponsor's protocol ID
- 22.115.01
- Acronym
- ISWAY
- Status last verified
- Sep 2026
- First submitted
- 28 May 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Biological Mechanisms Driving the Intergenerational Impact of War on Child Mental Health: Implications for Developing Family-Based Interventions
- ClinicalTrials.gov ID
- NCT06440460
- Acronym / sponsor ID
- ISWAY / 22.115.01
- Conditions
- Anxiety Disorders, Anxiety State, Depressive Disorder, Mood Disorders, Trauma and Stressor Related Disorders, Social Skills
- Keywords
- Early Child Development, Sierra Leone, Observational Study, Longitudinal, Emotion Regulation, Self Regulation, Mental Health, Stress
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 804 participants (estimated)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- University of Makeni, Caritas Freetown, Tulane University, Kenema Government Hospital
- Study start
- 27 May 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Translation and adaptation of newly selected measures
- 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.
- Fifth wave of data collection from war-affected youth who are now parents and their children aged 7-24.
- 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).
- 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:
- Childhood war-related trauma exposure will be associated with mental difficulties (anxiety, depression, post-traumatic stress, disruptions of emotion regulation).
- Poor mental health in war-affected parents will be associated with emotional and behavioral disruptions in biological offspring.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hopkins Symptom Checklist (HSCL)
Time frame: May-December 2024
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.
Center for Epidemiological Studies Depression Scale-Child (CESD-Child)
Time frame: May-December 2024
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.
UCLA PTSD Reaction Index-Revised (UCLA PTSD-RI)
Time frame: May-December 2024
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.
Child Behavior Checklist (CBCL)
Time frame: May-December 2024
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.
Difficulties in Emotion Regulation Scale (DERS)
Time frame: May-December 2024
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.
Oxford Measure of Psychosocial Adjustment (OMPA)
Time frame: May-December 2024
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.
Rapid Assessment of. Cognitive and Emotional Regulation (RACER)
Time frame: May-December 2024
Observation of child and caregiver cognitive functioning
Kaufman Assessment Battery for Children
Time frame: May-December 2024
Observation of child's
SWAY Parenting
Time frame: May-December 2024
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.
Adapted UNICEF Multiple Indicator Cluster Survey Child Discipline Module
Time frame: May-December 2024
Caregiver self-report of child discipline practices and behaviors
Parenting Acceptance and Rejection Questionnaire (PARQ)
Time frame: May-December 2024
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.
Coding Interactive Behavior
Time frame: May-December 2024
Coding system for observation of caregiver-child interactions
Early Grade Reading Assessment Early Grade Reading Assessment
Time frame: May-December 2024
Observation of child's early literacy skills
Early Grade Math Assessment
Time frame: May-December 2024
Observation of child's early numeracy skills
Autonomic Stress Reactivity
Time frame: May-December 2024
Measure of caregiver and child's autonomic response to stress via respiratory sinus arrhythmia (RSA)
Telomere Length
Time frame: May-December 2024
Measure of caregiver and child's telomere length
Inflammation
Time frame: May-December 2024
Measure of caregiver and child's inflammatory markers (e.g., C-reactive protein)
Post-War Adversities Scale
Time frame: May-December 2024
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.
Perceived Stress Scale (PSS)
Time frame: May-December 2024
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.
Childhood Trauma Questionnaire (CTQ)
Time frame: May-December 2024
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.
14 secondary outcomes
Brief COPE Scale
Time frame: May-December 2024
Normative Beliefs about Aggression Scale (NBA)
Time frame: May-December 2024
Post-Traumatic Growth Inventory (PTGI)
Time frame: May-December 2024
Adapted Youth Risk Behavior Survey
Time frame: May-December 2024
WHO Disability Adjustment Scale (WHODAS)
Time frame: May-December 2024
Child Rating Scale (CRS)
Time frame: May-December 2024
Demographic and Health Survey (DHS) - Intimate Partner Violence (IPV)
Time frame: May-December 2024
Dyadic Adjustment Scale (DAS)
Time frame: May-December 2024
Demographic and Health Survey (DHS) Sierra Leone Household Module
Time frame: May-December 2024
Perceived Community Acceptance (PCA)
Time frame: May-December 2024
Collective Efficacy Scale (CES)
Time frame: May-December 2024
Everyday Discrimination Scale (EDS)
Time frame: May-December 2024
Inventory of Socially Supportive Behaviors (ISSB)
Time frame: May-December 2024
Gender Equitable Men scale (GEM)
Time frame: May-December 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa S Betancourt principal investigator
Boston College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders and Anxiety State, run by Boston College at 1 site in Sierra Leone.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hopkins Symptom Checklist (HSCL) (time frame: May-December 2024). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.