RCT of FIND Video Coaching Intervention for Caregivers Facing Economic Adversity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Self-reported incidence of challenging child behaviors
研究概览
简要总结
FIND (Filming Interactions to Nurture Development) is a potentially disruptive innovation in the field of early childhood intervention. The scientific premise of this proposed work, for which the investigators have strong preliminary evidence, is that for families experiencing economic adversity and related stressors with children ages 12-36 months, the FIND video-coaching program is a potent and efficient tool that addresses many of the known limitations of existing parenting programs and therefore has great potential for achieving impact at scale to support low-income children's optimal development. Our research on FIND to date (including a recently completed randomized efficacy trial) provides evidence of effects on responsive caregiving and key child developmental outcomes at lower dosages (and with greater potential for scalability) than do most existing programs. Preliminary data also suggest that FIND may be especially effective for caregivers with high levels of adverse early life experiences (who are typically difficult to engage/impact). Finally, and potentially quite noteworthy, preliminary data indicate that FIND may achieve such effects via improvement in specific domains of underlying caregiver brain functioning. This research therefore aims to conduct a randomized effectiveness trial in the context of a diverse sample of low-income families with children ages 12-36 months (at study entry) using a longitudinal design with an active control condition.
详细描述
The investigators will test the central hypothesis that associations between (a) increases in responsive caregiving (the main FIND target) and (b) subsequent caregiver well-being and child developmental and biobehavioral outcomes (secondary targets), will be partially mediated through (c) changes in caregiver neuroimaging-based and behavioral measures of inhibitory control and parent self-concept. The investigators will also examine moderators of hypothesized intervention effects.
Aim 1: Quantify main effects of FIND on intervention targets (changes in responsive caregiving) and related caregiver and child outcomes.
Hypothesis 1a: Compared with an active control, FIND will significantly increase developmentally supportive, responsive caregiving immediately post-intervention and will endure at the 6-month longitudinal follow-up. These effects will be associated with enduring improvements in self-reported caregiving self-efficacy and stress.
Hypothesis 1b: Compared with an active control, FIND will significantly improve child developmental outcomes on cognitive, socioemotional, expressive language and biobehavioral measures (including child chronic stress assessed via hair cortisol concentrations, HCC and Heart Rate Variability, HRV), as well as measures of caregiver and child well-being. The investigators will also test whether FIND-related increases in responsive caregiving (Hypothesis 1a) are associated (at postintervention and 6-month follow-up) with child outcomes.
Aim 2: Use fMRI to identify process-level neural mechanisms underlying FIND intervention effects (i.e., why FIND works) and variations in these effects (i.e., for whom FIND works). The investigators hypothesize that FIND-related changes in underlying brain and behavioral mechanisms of caregiver inhibitory control and parenting self-concept will partially mediate observed changes in responsive caregiving. The investigators will also determine how between-subjects variation in changes in these brain measures is associated with differential response to sustained intervention impacts on responsive caregiving, which could be key in future work on increasing the impact of FIND for a broader range of recipients and on developing adaptations for low-responding groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Research assistants collecting the data during lab visits will not know the condition of the participant and will therefore not be biased during data collection.
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Self-reported incidence of challenging child behaviors
时间窗: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Self-report measures of challenging child behaviors, including internalizing and externalizing behaviors, via the Child Behavior Checklist (CBCL).
Incidence of parenting stress and child behaviors via the parent daily report
时间窗: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
A caregiver self-report of the incidence of challenging child behaviors and whether the caregiver perceives the behaviors to be stressful if they are occurring.
Parent Reward Task (PRT) behavior and associated brain activity
时间窗: Change from baseline at endpoint (3-4 months post-baseline)
Self-reported ratings of stimuli will be used as a behavioral measure of reward (higher = better), and ventral striatum activity will be used as a measure of reward responsivity using a contrast of own child \> other child.
Concentration of hair cortisol
时间窗: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Cumulative HPA axis activity measured via hair cortisol concentrations (HCC)
Self-reported level of social-emotional development
时间窗: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Caregiver report of their child's social emotional problems and competencies. The measure consists of 42 items that are on a 3-point scale (0=not true/rarely, 1=somewhat true/sometimes, 2=very true/always). For certain items a respondent may also respond "N" which means "no opportunity". The measure includes two subscales: * problem total score (31 items) with items summed into a score ranging between 31-93; total score is compared to cut scores (age in months, gender, and cut score) to indicate if there is a possible problem. The problem total cut score is set at the 25th percentile. * competence total score (11 items) with items summed into a score ranging between 11-33; total score is compared to cut scores (age in months, gender, cut score) to indicate if there is a possible problem. The competency total cut score is set at the 15th percentile.
Incidence of parenting stress via the parent stress index IV
时间窗: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Incidence of parenting stress via the Parent Stress Index-IV. Items are on a 5-point scale ranging from "strongly agree" to "strongly disagree." Higher scores indicated greater parenting stress. The measures includes three subscales and a total score: * parental distress (12 items) sum score ranging between 12-60 * parent-child dysfunctional interaction (12 items) sum score ranging between 12-60 * difficult child (12 items) sum score ranging between 12-60 * total score (36 items) sum score ranging between 36-180
Self-reported level of perceived sense of competency
时间窗: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Caregiver's perceived sense of competency in parenting via the Parent Sense of Competency scale. Items are on a 4-point scale ranging from "strongly agree" to "strongly disagree." Higher scores indicate greater parenting self-competency. The measure includes two subscales and a total score: * satisfaction (9 items) with items summed into a score ranging between 9-36 * efficacy (8 items) with items summed into a score ranging between 8-32 * total score (18 items) with items summed into a score ranging between 18-72
Observed level of inhibitory control via the Stop Signal Task
时间窗: Change from baseline at endpoint (3-4 months post-baseline)
Inhibitory control will be assessed by the Stop Signal Task (SST) during an MRI scan. The task speed adjusts based on performance and a single response time score will be outputted for each participant. The key neural measure is the degree of blood oxygenation-level dependent (BOLD) signal during stop trials relative to go trials (i.e., the "stop \> go" contrast over the entire trial period).
Observed spoken language via LENA audio recordings
时间窗: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
LENA is an audio recording device used to record spoken language in the natural environment. Software automatically analyzes recordings into several different metrics including estimates and percentile scores for adult words spoken to child, conversational turns, child vocalizations, and audio environment.
Coded rate of responsive caregiving via the serve and return scale
时间窗: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
The Serve and Return Scale (SRS) is a global coding system used to assess responsive parenting via the FIND 5 Elements. This scale will be used to assess the quality of caregiver responsiveness and the quantity of serve and return interaction in a 10-minute video of free-play between caregivers and their children. Items are on a 3-point scale between low, medium, and high. Higher scores indicate greater rates of responsive caregiving. The measure includes three subscales and a total score: * noticing the child's serves (1 item) score ranging between 1-3 * returning the child's serves (5 items) sum score ranging between 5-15 * caregiver initiation (1 item) score ranging between 1-3 * total score (7 items) sum score ranging between 7-21
Parent Self-Evaluation Task (PSET) behavior and associated brain activity
时间窗: Change from baseline at endpoint (3-4 months post-baseline)
Percentage of developmentally-supportive (DS) and developmentally-unsupportive (DU) traits endorsed under the self instruction will be used as a behavioral measure of parenting self-concept, and medial prefrontral cortex activity (mPFC) will be measured via the Self \> Change contract for DS traits
Coded rate of responsive caregiving via conversational turns
时间窗: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Conversational turns is a simple coding scheme designed to record timing, quantity, and length of caregiver and child utterances.
Coded rate of responsive caregiving via the simple interactions scale
时间窗: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
The simple interactions scale is a micro-social rating scale that assesses the quality and quantity of interaction between caregivers and their children. The scale is split into two parts: connection and reciprocity. Connection is a measure of synchrony between the caregiver-child dyad. Reciprocity is a moment-to-moment measure of serve and return interactions. Coding for both connection and reciprocity is on a 1-3 scale (CX \[1\], CY \[2\], and CZ \[3\] for connections; RX \[1\], RY \[2\], and RZ \[3\] for reciprocity) using a flowchart and accompanying glossary of terms. Connections is rated frame by frame, while reciprocity is rated in 15-second chunks. Within Connections and Reciprocity, the X (1), Y (2), and Z (3) codes are summed and expressed as a percentage of the total video. If 20 of the 40 reciprocity time segments were coded CX, then CX = 50%. A higher percentage of Z (3) represents higher levels of connection and reciprocity in the caregiver-child interaction.
次要结局
- Incidence of poor caregiver mental health(Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint)
- Incidence of early adversity(Baseline)
- Demographics(Baseline)
- Number of intervention sessions completed(reported at end of intervention, 3-4 months post-baseline)
- Percentage of intervention sessions at fidelity(reported at end of intervention, 3-4 months post-baseline)