Child AbusePhase 2NCT06732310
The Unique and Combined Effects of Prenatal and Early Childhood Programming on Child Maltreatment: Examining Mechanisms of Change
A Phase 2 study testing Pregnant Moms' Empowerment Program, Reminiscing and Emotion Training and Enhanced Case Management in people with Child Abuse and Intimate Partner Violence, run by University of Notre Dame at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Child Abuse, Intimate Partner Violence, Secondary Prevention
- What is being tested?
- Pregnant Moms' Empowerment Program, Reminiscing and Emotion Training and Enhanced Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Nov 2024to 31 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Wisconsin - Madison
Madison, Wisconsin, 53706
University of Notre Dame
Notre Dame, Indiana, 46556
About this study
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.
Read the 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.
- Being tested
- Pregnant Moms' Empowerment Program, Reminiscing and Emotion Training, Pregnancy - Active Control, Enhanced Case Management
- Keywords
- child abuse, child maltreatment, intimate partner violence, domestic violence, secondary prevention, parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant Moms' Empowerment ProgramBehavioural
Also called PMEP
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.
Reminiscing and Emotion TrainingBehavioural
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.
Pregnancy - Active ControlBehavioural
Also called AC
Women who are not randomized to the PMEP participate in a contact-equivalent, nondirective social support group.
Enhanced Case ManagementBehavioural
Also called ECM
Families randomized to this attentional control condition will receive enhanced case management. They will be mailed a kit containing 5 packets to be opened weekly. Each packet includes a family activity and a newsletter with parenting materials (e.g., Adventures in Parenting curriculum developed by NICHD) that were selected to not overlap with RET content (e.g., reading together, fitness, etc.). Using mothers' responses regarding access to resources on the Family Resource Scale (Dunst \& Leet, 1987), which is completed during the baseline visit, mothers will also receive referrals to community resources for items rated as inadequate.
| Study group | Role | What they receive |
|---|---|---|
| PMEP + ECM | Experimental | In pregnancy: PMEP
In early childhood: enhanced case management Receives: Behavioral: Pregnant Moms' Empowerment Program; Behavioral: Enhanced Case Management |
| Pregnancy - Active Control + RET | Experimental | 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. Receives: Behavioral: Reminiscing and Emotion Training; Behavioral: Pregnancy - Active Control |
| PMEP + RET | Experimental | In pregnancy: PMEP
In early childhood: Reminiscing and Emotion Training Program Receives: Behavioral: Pregnant Moms' Empowerment Program; Behavioral: Reminiscing and Emotion Training |
| Pregnancy - Active Control + ECM | Active comparator | 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. Receives: Behavioral: Pregnancy - Active Control; Behavioral: Enhanced Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCS Records - Maltreatment Classification System
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.
Measured: RET baseline (T5), 6 month follow-up (T8). 12 month follow-up
Maternal Maltreatment Classification Interview
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.
Measured: RET baseline (T5), 6 month follow-up (T8)
Maltreatment risk/Propensity
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.
Measured: 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]
Intimate partner violence
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.
Measured: 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]
Maternal Sensitivity - perinatal period
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).
Measured: PMEP 3 month post-partum follow-up [T3], PMEP 12 month post-partum follow-up [T4]
Maternal Sensitive Guidance - early childhood
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).
Measured: RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]
Maternal Sensitivity - DPICS - early childhood
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.
Measured: RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]
Secondary outcomes (6)
Positive Parenting Behavior
Positive parenting behavior will be assessed using selected subscales of the Alabama Parenting Questionnaire - Preschool Version (Clerkin, et al., 2007).
Measured: RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8)
Maternal emotional style
Maternal emotion style will be assessed using the Maternal Emotional Style Questionnaire (Lagacé-Séguin' \& Coplan' 2005).
Measured: RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8)
Child Emotion Regulation
Children's emotion regulation will be assess via parent report on the Emotion Regulation Checklist (Shields \& Cicchetti, 1997).
Measured: RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8)
Child Temperament - infancy
Child temperament will be collected as a covariate. Mothers will complete the Infant Behavior Questionnaire at T4 (Rothbart, et al., 2001) which assesses multiple aspects of early child temperament.
Measured: PMEP 12 month postpartum follow-up (T4)
Child Temperament - early childhood
Child temperament will be collected as a covariate. Mothers will complete the the Child Behavior Questionnaire at T5-T8 (Rothbart, et al., 2001) which assesses multiple aspects of early child temperament.
Measured: RET baseline (T5), RET immediate post-test (T6), RET 3 month follow-up (T7), RET 6 month follow-up (T8)
Child Adjustment
Child adjustment will be assessed using the Child Behavior Checklist (Achenbach, 1999) at assessments T5-T8.
Measured: RET baseline (T5), RET immediate post-test (T6), RET 3 month follow-up (T7), RET 6 month follow-up (T8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start7 Nov 2024
- Primary completion30 Mar 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Laura E Miller-Graff, PhD, Principal investigator, University of Notre DameKathryn H Howell, PhD, Principal investigator, University of Wisconsin, MadisonKristin Valentino, PhD, Principal investigator, University of Notre Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732310
- Sponsor's protocol ID
- 22-05-7238
- Other IDs
- R01HD114597
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants were not consented for IPD sharing in the initial study. Study data are sensitive and some data is highly protected (e.g., DCS records).
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Unique and Combined Effects of Prenatal and Early Childhood Programming on Child Maltreatment: Examining Mechanisms of Change
- ClinicalTrials.gov ID
- NCT06732310
- Acronym / sponsor ID
- 22-05-7238
- Keywords
- child abuse, child maltreatment, intimate partner violence, domestic violence, secondary prevention, parenting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| PMEP + ECM | Experimental | Behavioral: Pregnant Moms' Empowerment Program, Behavioral: Enhanced Case ManagementIn pregnancy: PMEP In early childhood: enhanced case management |
| Pregnancy - Active Control + RET | Experimental | Behavioral: Reminiscing and Emotion Training, Behavioral: Pregnancy - Active ControlIn 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. |
| PMEP + RET | Experimental | Behavioral: Pregnant Moms' Empowerment Program, Behavioral: Reminiscing and Emotion TrainingIn pregnancy: PMEP In early childhood: Reminiscing and Emotion Training Program |
| Pregnancy - Active Control + ECM | Active comparator | Behavioral: Pregnancy - Active Control, Behavioral: Enhanced Case ManagementIn 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. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnant Moms' Empowerment ProgramAlso: PMEPWomen 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. | Behavioural | PMEP + ECM, PMEP + RET |
| Reminiscing and Emotion TrainingEach 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. | Behavioural | PMEP + RET, Pregnancy - Active Control + RET |
| Pregnancy - Active ControlAlso: ACWomen who are not randomized to the PMEP participate in a contact-equivalent, nondirective social support group. | Behavioural | Pregnancy - Active Control + ECM, Pregnancy - Active Control + RET |
| Enhanced Case ManagementAlso: ECMFamilies randomized to this attentional control condition will receive enhanced case management. They will be mailed a kit containing 5 packets to be opened weekly. Each packet includes a family activity and a newsletter with parenting materials (e.g., Adventures in Parenting curriculum developed by NICHD) that were selected to not overlap with RET content (e.g., reading together, fitness, etc.). Using mothers' responses regarding access to resources on the Family Resource Scale (Dunst \& Leet, 1987), which is completed during the baseline visit, mothers will also receive referrals to community resources for items rated as inadequate. | Behavioural | PMEP + ECM, Pregnancy - Active Control + ECM |
Primary outcome
DCS Records - Maltreatment Classification System
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Positive Parenting Behavior
Time frame: RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8)
Maternal emotional style
Time frame: RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8)
Child Emotion Regulation
Time frame: RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8)
Child Temperament - infancy
Time frame: PMEP 12 month postpartum follow-up (T4)
Child Temperament - early childhood
Time frame: RET baseline (T5), RET immediate post-test (T6), RET 3 month follow-up (T7), RET 6 month follow-up (T8)
Child Adjustment
Time frame: RET baseline (T5), RET immediate post-test (T6), RET 3 month follow-up (T7), RET 6 month follow-up (T8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No. Participants were not consented for IPD sharing in the initial study. Study data are sensitive and some data is highly protected (e.g., DCS records).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura E Miller-Graff, PhD principal investigator
University of Notre Dame
Kathryn H Howell, PhD principal investigator
University of Wisconsin, Madison
Kristin Valentino, PhD principal investigator
University of Notre Dame
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pregnant Moms' Empowerment Program, Reminiscing and Emotion Training and Enhanced Case Management in people with Child Abuse and Intimate Partner Violence, run by University of Notre Dame at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCS Records - Maltreatment Classification System (time frame: RET baseline (T5), 6 month follow-up (T8). 12 month follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.