Clinical trial NCT06732310: The Unique and Combined Effects of Prenatal and Early Childhood Programming on Child Maltreatment: Examining Mechanisms of Change
Official title: The Unique and Combined Effects of Prenatal and Early Childhood Programming on Child Maltreatment: Examining Mechanisms of Change
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Child Abuse
Intimate Partner Violence
Secondary Prevention
Parenting
Keywords: child abuse
child maltreatment
intimate partner violence
domestic violence
secondary prevention
parenting
Lead sponsor: University of Notre Dame
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-12-13
Enrollment: 600
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: In pregnancy: Women who receive the PMEP complete a structured set of sessions delivered over the course of 5 weeks, each session lasts 2 hours in duration: (1) becoming a group \& safety planning, (2) identifying and understanding sources of stress, (3) strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting. Women who are not randomized to PMEP participate in a contact-equivalent, non-directive social support group.

In early childhood: Each of the 5 RET sessions are 1 hour in duration. The program is manualized and each session includes teaching/review of skills, instructions/activity with rationale, reminiscing practice, and immediate video feedback by a family coach. 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.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Women and children newly enrolled in the PMEP trial arm as part of the current study will complete eight assessments. These will include four PMEP trial arm assessments (baseline \[T1\], post-test \[T2\], 3 month post-partum follow-up \[T3\], and 12 month post-partum follow-up \[T4\]) and four more assessments (baseline \[T5\], post-test \[T6\], 3 month follow-up \[T7\], 6 month follow-up \[T8\]) completed as part of the RET trial arm. Dyads only participating in the RET trial arm will participate in the 4 RET assessments (i.e., T5-T8). Women will be compensated for each assessment and children will receive a small toy.

Primary outcome measures will include DCS records (gathered at T5, T8, and 12 month follow-up) coded using the Maltreatment Classification System, the Maternal Maltreatment Classification Interview, the Adult Adolescent Parenting inventory, the Child Abuse Potential Inventory, the Revised Conflict Tactics Scale, and Maternal Sensitivity (coded from observational data). A number of covariates will also be collected, including maternal mental health, childhood trauma and traumatic/major life events over the study period, child exposure to other forms of violence, child temperament, and social support.

For women randomized to receive the PMEP intervention, participation will include five group sessions that utilize interactive learning and group-based discussion to empower women to end intergenerational cycles of violence and develop skills for sensitive, responsive parenting. PMEP includes a structured set of sessions, each 2 hours in duration: (1) becoming a group and safety planning, (2) identifying and understanding sources of stress, (3) strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting.

For women randomized to receive RET, participation in the program will include five virtual RET sessions that aim to promote a positive, nurturing parent-child relationship during early childhood through training in sensitive parent-child communication about children's emotions. RET sessions will be 1 hour in duration. The program is manualized and each session includes teaching/review of skills, instructions/activity with rationale, reminiscing practice, and immediate video feedback by a family coach.

Eligibility criteria: 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.

Primary outcomes:
measure: DCS Records - Maltreatment Classification System
timeFrame: RET baseline (T5), 6 month follow-up (T8). 12 month follow-up
measure: Maternal Maltreatment Classification Interview
timeFrame: RET baseline (T5), 6 month follow-up (T8)
measure: Maltreatment risk/Propensity
timeFrame: 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]
measure: Intimate partner violence
timeFrame: 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]
measure: Maternal Sensitivity - perinatal period
timeFrame: PMEP 3 month post-partum follow-up [T3], PMEP 12 month post-partum follow-up [T4]
measure: Maternal Sensitive Guidance - early childhood
timeFrame: RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]
measure: Maternal Sensitivity - DPICS - early childhood
timeFrame: RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]
Secondary outcomes:
measure: Positive Parenting Behavior
timeFrame: RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8)
measure: Maternal emotional style
timeFrame: RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8)
measure: Child Emotion Regulation
timeFrame: RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8)
measure: Child Temperament - infancy
timeFrame: PMEP 12 month postpartum follow-up (T4)
measure: Child Temperament - early childhood
timeFrame: RET baseline (T5), RET immediate post-test (T6), RET 3 month follow-up (T7), RET 6 month follow-up (T8)
measure: Child Adjustment
timeFrame: RET baseline (T5), RET immediate post-test (T6), RET 3 month follow-up (T7), RET 6 month follow-up (T8)
Other outcomes:
measure: Maternal Trauma History
timeFrame: PMEP baseline [T1], RET baseline [T5]
measure: Maternal Child Maltreatment History
timeFrame: RET baseline [T5]
measure: Maternal Social Support
timeFrame: 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]
measure: Mother Verbal Ability
timeFrame: RET immediate follow-up [T6; mother]
measure: Maternal Mental Health - PTSD
timeFrame: 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]
measure: Maternal Mental Health - Depression
timeFrame: 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]
measure: Child victimization
timeFrame: RET baseline (T5), RET immediate post-test (T6), RET 3 month follow-up (T7), RET 6 month follow-up (T8)
measure: Child Verbal Ability
timeFrame: RET baseline [T5] and RET 6 month follow-up [T8]
Locations:
city: Notre Dame
country: United States
facility: University of Notre Dame
state: Indiana
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Notre Dame
name: Laura E Miller-Graff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Kathryn H Howell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Notre Dame
name: Kristin Valentino, PhD
role: PRINCIPAL_INVESTIGATOR
References: