The Unique and Combined Effects of Prenatal and Early Childhood Programming on Child Maltreatment: Examining Mechanisms of Change
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- DCS Records - Maltreatment Classification System
研究概览
简要总结
Child maltreatment and child exposure to adult intimate partner violence (IPV) often co-occur and are detrimental to the mental and physical health of children, yet few prevention programs address these intersecting forms of adversity using dual-generation approaches. The proposed study is a rigorous randomized controlled trial that uses a 2x2 factorial design to evaluate the potential synergistic benefits of delivering programming prenatally and during early childhood in order to support the mother-child relationship and ultimately prevent child maltreatment. If effective in preventing child maltreatment, these programs have the potential for high public health impact given that they are both cost-effective and readily scalable.
详细描述
The study will occur at two sites - the University of Notre Dame and the University of Memphis. A total of N=300 mother-child dyads will participate, with an equal number of dyads drawn from each site - Memphis, TN (n=115) and South Bend, IN (n=115). The sample will be composed of n=230 women and children drawn from an ongoing randomized clinical trial (RCT) of the PMEP (R01HD098092); during Year 1 of the current study, we will implement the PMEP RCT protocol with an additional n=70 women, for a total sample of N=300 families.
In order to be eligible for the PMEP trial arm, women must be: 18 years or older, pregnant (between 10 and 30 weeks), English speaking, and exposed to IPV in the past year. To be eligible for re-enrollment in the RET trial arm, women must have previously participated in the PMEP trial arm. Women who have a significant mental health disorder or cognitive impairment that precludes their ability to understand or participate in the intervention will be excluded. Mothers who have experienced miscarriage, infant death, or who no longer have custody of the child with whom they were pregnant with when they participated in the PMEP trial arm will be excluded from the intervention given that the RET trial arm requires active participation from both parent and child; if mothers, however, have had another child who was born after PMEP who is in the eligible age range, they may participate.
The primary objective of the current study is to evaluate the unique and combined effects of evidence-based prenatal (i.e., Pregnant Moms' Empowerment Program) and early childhood (i.e., Reminiscing and Emotion Training) programming to prevent child maltreatment.
Study hypotheses are tested in a 2x2 randomized controlled trial design, with four conditions: PMEP + early childhood control, PMEP + RET, prenatal control + RET, or prenatal and early childhood controls.
Enrollment will continue for approximately 3.5 years, with an expected enrollment rate of approximately 8 mother-child dyads per month. For mother-child dyads who participated in the RCT of the PMEP (n = 230) the expected duration of the RET arm will be approximately 11 months. For the mother-child dyads who will be newly enrolled into the PMEP trial arm as part of the proposed study, the expected duration of the PMEP arm is 16 months; when these children are 3-6 years old, they will participate in the RET arm for 11 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The sample will be composed of n=230 women and children drawn from an ongoing randomized clinical trial (RCT) of the PMEP (R01HD098092); during Year 1 of the current study, we will recruit an additional n=70 pregnant, IPV-exposed women and implement the PMEP RCT protocol with them, for a total sample of N=300 families.
- •In order to be eligible for the PMEP trial arm, women must be: 18 years or older, pregnant (between 10 and 30 weeks), English speaking, and exposed to IPV in the past year. To be eligible for re-enrollment in the RET trial arm, women must have previously participated in the PMEP trial arm. Women who have a significant mental health disorder or cognitive impairment that precludes their ability to understand or participate in the intervention will be excluded. Mothers who have experienced miscarriage, infant death, or who no longer have custody of the child with whom they were pregnant with when they participated in the PMEP trial arm will be excluded from the intervention given that the RET trial arm requires active participation from both parent and child; if, however, women have a child born after their participation in PMEP and who is in the study age range, they and their child may participate.
排除标准
- 未提供
研究组 & 干预措施
PMEP + ECM
In pregnancy: PMEP
In early childhood: enhanced case management
干预措施: Pregnant Moms' Empowerment Program (Behavioral)
PMEP + ECM
In pregnancy: PMEP
In early childhood: enhanced case management
干预措施: Enhanced Case Management (Behavioral)
Pregnancy - Active Control + RET
In pregnancy: Women who are not randomized to PMEP participate in a contact-equivalent, non-directive social support group.
In early-childhood: Women participant in the RET.
干预措施: Reminiscing and Emotion Training (Behavioral)
Pregnancy - Active Control + RET
In pregnancy: Women who are not randomized to PMEP participate in a contact-equivalent, non-directive social support group.
In early-childhood: Women participant in the RET.
干预措施: Pregnancy - Active Control (Behavioral)
PMEP + RET
In pregnancy: PMEP
In early childhood: Reminiscing and Emotion Training Program
干预措施: Pregnant Moms' Empowerment Program (Behavioral)
PMEP + RET
In pregnancy: PMEP
In early childhood: Reminiscing and Emotion Training Program
干预措施: Reminiscing and Emotion Training (Behavioral)
Pregnancy - Active Control + ECM
In pregnancy: Women not randomized to PMEP will participate in a contact-equivalent, nondirective social support group.
In early childhood: Families who are not randomized to the RET condition will be mailed a kit containing 5 packets to be opened weekly. Each packet includes a family activity and a newsletter with parenting materials.
干预措施: Pregnancy - Active Control (Behavioral)
Pregnancy - Active Control + ECM
In pregnancy: Women not randomized to PMEP will participate in a contact-equivalent, nondirective social support group.
In early childhood: Families who are not randomized to the RET condition will be mailed a kit containing 5 packets to be opened weekly. Each packet includes a family activity and a newsletter with parenting materials.
干预措施: Enhanced Case Management (Behavioral)
结局指标
主要结局
DCS Records - Maltreatment Classification System
时间窗: RET baseline (T5), 6 month follow-up (T8). 12 month follow-up
DCS records will be coded using the Maltreatment Classification System (MCS; Barnett et al., 1993). The MCS utilizes operational criteria for determining the occurrence of subtypes of maltreatment. Subtype categories include sexual abuse, physical abuse, physical neglect, and emotional maltreatment.
Maternal Maltreatment Classification Interview
时间窗: RET baseline (T5), 6 month follow-up (T8)
MCS ratings will be supplemented by information obtained during the Maternal Maltreatment Classification Interview (MMCI; Cicchetti et al., 2002), a structured interview based on the MCS. It will be audiotaped and coded by two independent raters utilizing the same operational criteria as the MCS.
Maltreatment risk/Propensity
时间窗: PMEP baseline [T1], PMEP immediate post-test [T2], PMEP 3 month post-partum follow-up [T3], PMEP 12 month post-partum follow-up [T4], RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]
Mothers will complete the Child Abuse Potential Inventory (CAPI; Milner, 1986) and the Adult Adolescent Parenting Inventory (AAPI; Bavolek \& Keene, 2001), both of which assess maltreatment propensity. A composite variable of maltreatment propensity/risk will be created by combining these indicators.
Intimate partner violence
时间窗: PMEP baseline [T1], PMEP immediate post-test [T2], PMEP 3 month post-partum follow-up [T3], PMEP 12 month post-partum follow-up [T4], RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]
others will complete the Revised Conflict Tactics Scale (CTS2) (Straus, Hamby, Boney-McCoy, \& Sugarman, 1996; Straus, 1979), which assesses the severity of psychological, physical, and sexual violence in a dating, cohabiting, or marital relationship. This measure has the advantage of being able to be flexibly coded to gain information about IPV severity, frequency, and chronicity.
Maternal Sensitivity - perinatal period
时间窗: PMEP 3 month post-partum follow-up [T3], PMEP 12 month post-partum follow-up [T4]
Maternal sensitivity will be assessed in several observational contexts. At T3 and T4, mother-child dyads will participate in a 5-minute free play activity that will be coded using an established coding framework (Braungart-Rieker et al., 2014).
Maternal Sensitive Guidance - early childhood
时间窗: RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]
From T5-T8, maternal sensitive guidance will be assessed by following the Autobiographical Emotional Events Dialogue procedure (AEED; Koren-Kari e, Oppenheim, Haimovich, \& Etzion-Carasso, 2003b).
Maternal Sensitivity - DPICS - early childhood
时间窗: RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]
Participants will also complete a 10-minute free play paradigm using an abbreviated Dyadic Parent-Child Interaction Coding System (DPICS; Eyeberg, et al., 2013). This free play will be coded for positive, neutral and negative patterns of parent-child communication.
次要结局
- Positive Parenting Behavior(RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8))
- Maternal emotional style(RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8))
- Child Emotion Regulation(RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8))
- Child Temperament - infancy(PMEP 12 month postpartum follow-up (T4))
- Child Temperament - early childhood(RET baseline (T5), RET immediate post-test (T6), RET 3 month follow-up (T7), RET 6 month follow-up (T8))
- Child Adjustment(RET baseline (T5), RET immediate post-test (T6), RET 3 month follow-up (T7), RET 6 month follow-up (T8))