NCT06440460

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. 1.Pilot to assess measure performance and field test study protocols.
  2. 2.Translation and adaptation of newly selected measures
  3. 3.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.
  4. 4.Fifth wave of data collection from war-affected youth who are now parents and their children aged 7-24.
  5. 5.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).
  6. 6.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.
  7. 7.Childhood war-related trauma exposure will be associated with mental difficulties (anxiety, depression, post-traumatic stress, disruptions of emotion regulation).
  8. 8.Poor mental health in war-affected parents will be associated with emotional and behavioral disruptions in biological offspring.
  9. 9.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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
804

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
May 2024Nov 2026

Study Start

First participant enrolled

May 27, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

May 28, 2024

Last Update Submit

August 4, 2025

Conditions

Keywords

Early Child DevelopmentSierra LeoneObservational StudyLongitudinalEmotion RegulationSelf RegulationMental HealthStressTraumaQuality of LifeStress BiomarkersBiological EmbeddingParenting

Outcome Measures

Primary Outcomes (20)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Rapid Assessment of. Cognitive and Emotional Regulation (RACER)

    Observation of child and caregiver cognitive functioning

    May-December 2024

  • Kaufman Assessment Battery for Children

    Observation of child's

    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.

    May-December 2024

  • Adapted UNICEF Multiple Indicator Cluster Survey Child Discipline Module

    Caregiver self-report of child discipline practices and behaviors

    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.

    May-December 2024

  • Coding Interactive Behavior

    Coding system for observation of caregiver-child interactions

    May-December 2024

  • Early Grade Reading Assessment Early Grade Reading Assessment

    Observation of child's early literacy skills

    May-December 2024

  • Early Grade Math Assessment

    Observation of child's early numeracy skills

    May-December 2024

  • Autonomic Stress Reactivity

    Measure of caregiver and child's autonomic response to stress via respiratory sinus arrhythmia (RSA)

    May-December 2024

  • Telomere Length

    Measure of caregiver and child's telomere length

    May-December 2024

  • Inflammation

    Measure of caregiver and child's inflammatory markers (e.g., C-reactive protein)

    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.

    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.

    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.

    May-December 2024

Secondary Outcomes (14)

  • Brief COPE Scale

    May-December 2024

  • Normative Beliefs about Aggression Scale (NBA)

    May-December 2024

  • Post-Traumatic Growth Inventory (PTGI)

    May-December 2024

  • Adapted Youth Risk Behavior Survey

    May-December 2024

  • WHO Disability Adjustment Scale (WHODAS)

    May-December 2024

  • +9 more secondary outcomes

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • being a cohabitating biological child (aged 7-24) of the index participant
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caritas Freetown

Freetown, Sierra Leone

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Anxiety DisordersDepressive DisorderMood DisordersTrauma and Stressor Related DisordersSocial SkillsEmotional RegulationSelf-ControlPsychological Well-BeingWounds and Injuries

Condition Hierarchy (Ancestors)

Mental DisordersSocial BehaviorBehaviorPersonal Satisfaction

Study Officials

  • Theresa S Betancourt

    Boston College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Salem Professor in Global Practice

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 3, 2024

Study Start

May 27, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations