Leveraging Scientific Advances to Strengthen the Implementation, Evaluation, and Impacts of Intervention Programs for Children Experiencing Early Life Adversity
概览
- 阶段
- 不适用
- 干预措施
- Attachment and Biobehavioral Catch-up (ABC)
- 疾病 / 适应症
- Parenting Intervention
- 发起方
- University of North Carolina, Chapel Hill
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Child inflammation
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
Purpose: The purpose of this research is to determine the effects of Attachment and Biobehavioral Catch-up (ABC), an evidence-based parenting program, on stress biomarkers in children.
Participants: The study will involve approximately 150 caregiver-child dyads, with children aged between 24 and 42 months. Participants will include primary caregivers fluent in English or Spanish, along with their children who have experienced social risk factors for adversity.
Procedures (Methods): Participants will be randomly assigned to either receive the ABC parenting program (10 sessions) immediately or be placed on a wait-list, receiving the program after about 4 months. The study procedures include caregivers completing online surveys, engaging in play-based observational tasks with their children, and collecting non-invasive biological samples (saliva, cheek swab, hair) from the children and saliva samples from the caregivers at 2-3 time-points.
研究者
入排标准
入选标准
- •Parent/Caregiver Inclusion Criteria :
- •Aged 18 or older
- •Speaks English or Spanish
- •Is the parent or legal guardian with legal custody of a child aged between 24 months and 42 months
- •Is a primary caregiver/parent
- •Has a home-like environment in which to participate in the intervention
- •Child Inclusion Criteria:
- •Aged between 24 months and 42 months at enrollment
- •Lives with the parent/caregiver at least 50% of the time
- •Has experienced social risk factors, including low income, community or family violence, previous trauma/adversity exposure, prolonged separation from caregiver, significant difficulties in relationship with caregiver Child
排除标准
- •Has a diagnosed genetic or congenital disorders, including but not limited to Down syndrome, cerebral palsy, seizure disorders, endocrine disorders (or is using steroid medications, including human growth hormone), or was born with birth defects
研究组 & 干预措施
ABC Program - no wait
Participants immediately receive the home-based ABC, which targets parenting sensitivity and nurturance.
干预措施: Attachment and Biobehavioral Catch-up (ABC)
Waitlist-Control (ABC after delay)
Participants will be placed on a four-month waitlist and then receive ABC in the same manner as the Experimental Group
干预措施: Attachment and Biobehavioral Catch-up (ABC)
Waitlist-Control (ABC after delay)
Participants will be placed on a four-month waitlist and then receive ABC in the same manner as the Experimental Group
干预措施: Waitlist with 4-month delay, then ABC
结局指标
主要结局
Child inflammation
时间窗: 13-20 weeks after baseline
Pediatric saliva samples will be assayed for cytokine concentrations.
Child epigenetic age acceleration
时间窗: 13-20 weeks after baseline
Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age
Child telomere length
时间窗: 13-20 weeks after baseline
DNA will be extracted from child buccal swabs to calculated T/S ratios.
Child hair cortisol
时间窗: 13-20 weeks after baseline
Several strands of hair will be collected and assayed to obtain hair cortisol concentration
Child stress hormones
时间窗: 13-20 weeks after baseline
Child hair and saliva samples for cortisol, cortisone, DHEA, progesterone, and endocannabinoid levels to examine both cumulative and dynamic stress hormone responses.
Parenting
时间窗: 13-20 weeks after baseline
Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment.
Child wellbeing
时间窗: 13-20 weeks after baseline
Caregiver reports of their child's quality of life will be obtained using the Pediatric Quality of Life (PedsQL) Inventory. Scores range from 0 to 100, with higher scores indicating better functioning.
Child executive functioning
时间窗: 13-20 weeks after baseline
Child executive functioning will be assessed using the Minnesota Executive Function Scale™ The MEFS has been nationally normed based on the child's age and standardized scores are automatically generated using an algorithm that combines accuracy and response time (M = 100, SD = 15). Scores range from 60-140, with higher scores indicating better performance.
Child mental health
时间窗: 13-20 weeks after baseline
Child mental health will be assessed using caregiver reports through the Child Behavior Checklist preschool-aged form (1.5-5). We will use the total, internalizing, and externalizing subscales, with scores ranging from 0-200, 0-72, and 0-48, respectively. Higher scores represent worse functioning.
Caregiver anxiety
时间窗: 13-20 weeks after baseline
Caregiver anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. The total score ranges from 0-21, with higher scores indicating more severe anxiety.
Caregiver depression
时间窗: 13-20 weeks after baseline
Caregiver depression symptoms will be assessed using the Patient Health Questionnaire-9 item form. Scores range from 0 to 27, with higher scores representing worse functioning.
Child inflammation
时间窗: Pre-intervention baseline
Pediatric saliva samples will be assayed for cytokine concentrations.
Child epigenetic age acceleration
时间窗: Pre-intervention baseline
Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age
Child telomere length
时间窗: Pre-intervention baseline
DNA will be extracted from child buccal swabs to calculated T/S ratios.
Child hair cortisol
时间窗: Pre-intervention baseline
Several strands of hair will be collected and assayed to obtain hair cortisol concentration
Child stress hormones
时间窗: Pre-intervention baseline
Child hair and saliva samples for cortisol, cortisone, DHEA, progesterone, and endocannabinoid levels to examine both cumulative and dynamic stress hormone responses.
Parenting
时间窗: Pre-intervention baseline
Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment.
Child wellbeing
时间窗: Pre-intervention baseline
Caregiver reports of their child's quality of life will be obtained using the Pediatric Quality of Life (PedsQL) Inventory. Scores range from 0 to 100, with higher scores indicating better functioning.
Child executive functioning
时间窗: Pre-intervention baseline
Child executive functioning will be assessed using the Minnesota Executive Function Scale™ The MEFS has been nationally normed based on the child's age and standardized scores are automatically generated using an algorithm that combines accuracy and response time (M = 100, SD = 15). Scores range from 60-140, with higher scores indicating better performance.
Child mental health
时间窗: Pre-intervention baseline
Child mental health will be assessed using caregiver reports through the Child Behavior Checklist preschool-aged form (1.5-5). We will use the total, internalizing, and externalizing subscales, with scores ranging from 0-200, 0-72, and 0-48, respectively. Higher scores represent worse functioning.
Caregiver anxiety
时间窗: Pre-intervention baseline
Caregiver anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. The total score ranges from 0-21, with higher scores indicating more severe anxiety.
Caregiver depression
时间窗: Pre-intervention baseline
Caregiver depression symptoms will be assessed using the Patient Health Questionnaire-9 item form. Scores range from 0 to 27, with higher scores representing worse functioning.