跳至主要内容
临床试验/NCT06440460
NCT06440460进行中(未招募)不适用

Social and Biological Mechanisms Driving the Intergenerational Impact of War on Child Mental Health: Implications for Developing Family-Based Interventions

Boston College1 个研究点 分布在 1 个国家目标入组 804 人开始时间: 2024年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
804
试验地点
1
主要终点
Hopkins Symptom Checklist (HSCL)

研究概览

简要总结

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.

  2. Translation and adaptation of newly selected measures

  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. Fifth wave of data collection from war-affected youth who are now parents and their children aged 7-24.

  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. 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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Hopkins Symptom Checklist (HSCL)

时间窗: 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.

Rapid Assessment of. Cognitive and Emotional Regulation (RACER)

时间窗: May-December 2024

Observation of child and caregiver cognitive functioning

Kaufman Assessment Battery for Children

时间窗: May-December 2024

Observation of child's

Parenting Acceptance and Rejection Questionnaire (PARQ)

时间窗: 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

时间窗: May-December 2024

Coding system for observation of caregiver-child interactions

Childhood Trauma Questionnaire (CTQ)

时间窗: 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.

Center for Epidemiological Studies Depression Scale-Child (CESD-Child)

时间窗: 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.

Child Behavior Checklist (CBCL)

时间窗: 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.

UCLA PTSD Reaction Index-Revised (UCLA PTSD-RI)

时间窗: 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.

Oxford Measure of Psychosocial Adjustment (OMPA)

时间窗: 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.

Difficulties in Emotion Regulation Scale (DERS)

时间窗: 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.

Adapted UNICEF Multiple Indicator Cluster Survey Child Discipline Module

时间窗: May-December 2024

Caregiver self-report of child discipline practices and behaviors

Early Grade Reading Assessment Early Grade Reading Assessment

时间窗: May-December 2024

Observation of child's early literacy skills

Autonomic Stress Reactivity

时间窗: May-December 2024

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

Telomere Length

时间窗: May-December 2024

Measure of caregiver and child's telomere length

Inflammation

时间窗: May-December 2024

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

Post-War Adversities Scale

时间窗: 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.

SWAY Parenting

时间窗: 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.

Early Grade Math Assessment

时间窗: May-December 2024

Observation of child's early numeracy skills

Perceived Stress Scale (PSS)

时间窗: 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.

次要结局

  • Adapted Youth Risk Behavior Survey(May-December 2024)
  • WHO Disability Adjustment Scale (WHODAS)(May-December 2024)
  • Brief COPE Scale(May-December 2024)
  • Demographic and Health Survey (DHS) Sierra Leone Household Module(May-December 2024)
  • Perceived Community Acceptance (PCA)(May-December 2024)
  • Gender Equitable Men scale (GEM)(May-December 2024)
  • Normative Beliefs about Aggression Scale (NBA)(May-December 2024)
  • Post-Traumatic Growth Inventory (PTGI)(May-December 2024)
  • Demographic and Health Survey (DHS) - Intimate Partner Violence (IPV)(May-December 2024)
  • Child Rating Scale (CRS)(May-December 2024)
  • Collective Efficacy Scale (CES)(May-December 2024)
  • Dyadic Adjustment Scale (DAS)(May-December 2024)
  • Everyday Discrimination Scale (EDS)(May-December 2024)
  • Inventory of Socially Supportive Behaviors (ISSB)(May-December 2024)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Theresa Betancourt

Salem Professor in Global Practice

Boston College

研究点 (1)

Loading locations...

相似试验

Intergenerational Study of War-Affected Youth | 临床试验