- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04068662
Intervention for IPV-exposed Pregnant Women
Intervening During the Prenatal Period With Women Exposed to Intimate Partner Violence to Improve Maternal Functioning and Infant Adjustment
The overarching goal of the proposed project is to evaluate a randomized clinical trial of the Pregnant Moms' Empowerment Program aimed at detecting its effects on maternal mental health, re-victimization, parenting sensitivity, and infant development. The project also seeks to examine theoretically-grounded mechanisms of change, including social support and empowerment. Women participating in the study will receive either the PMEP or participate in a contact-equivalent active control group during pregnancy, and will be interviewed at baseline, post-intervention and with their infants at 3 months and 1 year old. The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site - Memphis, Tennessee (n=115) and South Bend, Indiana (n=115). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the Pregnant Moms' Empowerment Program. The expected duration of the study for each participant will be approximately 1.5 years, with some variation due to women enrolling at different points in their pregnancy.
The primary objective of the proposed project is to determine if the Pregnant Moms' Empowerment Program has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development compared to women's participation in a contact-equivalent active control group. This objective will be evaluated using a multi-site randomized clinical trial design. Participants (N = 230) will be equally randomized into study arms. Eligible women will include those who are: 1) currently pregnant (primi or multiparous) and between 10 and 30 weeks gestation, 2) experienced IPV within the past year, 3) English speaking and 4) age 16 or older.
The study will include 9 total visits: 4 assessments and 5 sessions for both study arms. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with post-partum assessments somewhat longer than prenatal assessments given the addition of the infant developmental assessment and parent-child observation task. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Following the final assessment, women will be invited to complete a daily diary (virtually) each day for 30 days. Each survey will take approximately 5-10 minutes to complete, and women will be compensated $2 for each completed survey. Women will also receive a $10 bonus for each set of 10 consecutive surveys. Treatment sessions will be 2 hours in duration. Women in the PMEP will complete a structured set of sessions: (1) supporting each other, support in the community, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting. Women in the active control condition will participate in facilitated discussions on a topic identified by the group. All sessions will be audio recorded so that treatment fidelity can be evaluated (for the Pregnant Moms' Empowerment Program) and so that content overlap can be assessed (for the active control condition).
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laura Miller-Graff
- Phone Number: 574-631-3245
- Email: lmiller8@nd.edu
Study Locations
-
-
Indiana
-
Notre Dame, Indiana, United States, 46556
- Recruiting
- University of Notre Dame
-
Contact:
- Laura Miller-Graff, PhD
- Phone Number: 574-631-3245
- Email: lmiller8@nd.edu
-
Principal Investigator:
- Laura Miller-Graff, PhD
-
Sub-Investigator:
- E Mark Cummings, PhD
-
Sub-Investigator:
- Julia Braungart-Rieker, PhD
-
Sub-Investigator:
- Lijuan Wang, PhD
-
-
Tennessee
-
Memphis, Tennessee, United States, 38152
- Recruiting
- University of Memphis
-
Contact:
- Kathryn Howell, PhD
- Phone Number: 901-678-1541
- Email: khhwell1@memphis.edu
-
Principal Investigator:
- Kathryn Howell, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- currently pregnant (primi or multiparous)
- experienced intimate partner violence within the past year
- English speaking
- age 16 or older
- between 10-30 weeks pregnant
Exclusion Criteria:
- fails to meet inclusion criteria
- unavailable or unwilling to participate in core study components, including groups
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pregnant Moms' Empowerment Program
Five session group therapy program covering safety planning, resilience and coping, infant care and parenting.
|
The Pregnant Moms' Empowerment Program is a five session group therapy program designed for pregnant women with a recent history of exposure to intimate partner violence.
One session is administered each week with a duration of 2 hours each, for a total of ten contact hours across the course of the intervention.
Intervention topics includes safety planning, social support, resilience, psychoeducation about intimate partner violence, cognitive and behavioral strategies for remediating distress, infant sleep and breastfeeding, responsive parenting, and co-parenting.
|
Active Comparator: Nondirective Support Group
Five session nondirective support group with two co-leaders who assist in facilitating open discussion on women's self-identified discussion topics.
|
Participants in the non-directive support group condition participate in groups of the same size and with the same total contact time as women in Intervention 1.
In contrast to the structured, manualized content delivered as a part of the Pregnant Moms' Empowerment Program, however, group leaders in this condition facilitate open conversation on topics that women identify together as a group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in posttraumatic stress symptoms from baseline to post-treatment
Time Frame: posttreatment
|
Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013).
We hypothesize that compared to women in the active control condition, that beginning at the post-treatment assessment women in the treatment condition will have lower levels of posttraumatic stress.
Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support.
Items are summed to create a total score, which can range from 0 to 80. Higher scores indicate worse outcomes.
|
posttreatment
|
Change in posttraumatic stress symptoms from baseline to 3-months postpartum
Time Frame: 3-months postpartum
|
Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013).
We hypothesize that compared to women in the active control condition, women in the treatment condition will have lower levels of posttraumatic stress.
Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support.
Items are summed to create a total score, which can range from 0 to 80. Higher scores indicate worse outcomes.
|
3-months postpartum
|
Change in posttraumatic stress symptoms from baseline to 12-months postpartum
Time Frame: 12-months postpartum
|
Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013).
We hypothesize that compared to women in the active control condition, women in the treatment condition will have lower levels of posttraumatic stress.
Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support.
Items are summed to create a total score, which can range from 0 to 80. Higher scores indicate worse outcomes.
|
12-months postpartum
|
Change in depressed mood from baseline to posttreatment
Time Frame: posttreatment
|
Mothers will report on symptoms of depressed mood using the Center for Epidemiological Studies Depression Scale (Radloff, 1977).
We hypothesize that compared to women in the AC condition, that beginning at the post-treatment assessment (T2) women in the PMEP condition will have lower levels of depressed mood over time.
Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support.
Items are summed to create a total score, which can range from 0 to 60. Higher scores indicate worse outcomes.
|
posttreatment
|
Change in depressed mood from baseline to 3-months postpartum
Time Frame: 3-months postpartum
|
Mothers will report on symptoms of depressed mood using the Center for Epidemiological Studies Depression Scale (Radloff, 1977).
We hypothesize that compared to women in the active control condition, that beginning at that women in the treatment condition will have lower levels of depressed mood over time.
Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support.
Items are summed to create a total score, which can range from 0 to 60. Higher scores indicate worse outcomes.
|
3-months postpartum
|
Change in depressed mood from baseline to 12-months postpartum
Time Frame: 12-months postpartum
|
Mothers will report on symptoms of depressed mood using the Center for Epidemiological Studies Depression Scale (Radloff, 1977).
We hypothesize that compared to women in the active control condition, that beginning at that women in the treatment condition will have lower levels of depressed mood over time.
Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support.
Items are summed to create a total score, which can range from 0 to 60. Higher scores indicate worse outcomes.
|
12-months postpartum
|
Change in resilience from baseline to posttreatment
Time Frame: posttreatment
|
Mothers will report on resilience using the Connor-Davidson Resilience Scale (Connor & Davidson, 2003), which examines one's ability to cope with adversity.
We hypothesize that compared to women in the active control condition that women in the treatment condition will have higher levels of resilience over time.
Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support.
Items are summed to create a total score, which can range from 0 to 100.
Higher scores indicate better outcomes.
|
posttreatment
|
Change in resilience from baseline to 3-months postpartum
Time Frame: 3-months postpartum
|
Mothers will report on resilience using the Connor-Davidson Resilience Scale (Connor & Davidson, 2003), which examines one's ability to cope with adversity.
We hypothesize that compared to women in the active control condition that women in the treatment condition will have higher levels of resilience over time.
Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support.
Items are summed to create a total score, which can range from 0 to 100.
Higher scores indicate better outcomes.
|
3-months postpartum
|
Change in resilience from baseline to 12-months postpartum
Time Frame: 12-months postpartum
|
Mothers will report on resilience using the Connor-Davidson Resilience Scale (Connor & Davidson, 2003), which examines one's ability to cope with adversity.
We hypothesize that compared to women in the active control condition that women in the treatment condition will have higher levels of resilience over time.
Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support.
Items are summed to create a total score, which can range from 0 to 100.
Higher scores indicate better outcomes.
|
12-months postpartum
|
Maternal Sensitivity at infant age 3 months
Time Frame: 3-months postpartum
|
Maternal sensitivity will be assessed using observational paradigms coded by trained research assistants for sensitive parenting behaviors.
At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in a fixed-order observational assessment, constituted of the Still-Face Paradigm (Tronick et al., 1978) and a 10-minute free play period.
Parent sensitivity will be rated on a 5 point Likert scale from the play and reunion episodes.
Coded ratings on sensitivity and intrusiveness will be combined across intervals to create a composite maternal sensitivity score.
We hypothesize that compared to women in the active control condition, women in the treatment condition will show higher levels of maternal sensitivity at the 3-month postpartum assessment.
Higher scores indicate better outcomes.
|
3-months postpartum
|
Maternal Sensitivity at infant age 12 months
Time Frame: 12-months postpartum
|
Maternal sensitivity will be assessed using observational paradigms coded by trained research assistants for sensitive parenting behaviors.
At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in a fixed-order observational assessment, constituted of the Still-Face Paradigm (Tronick et al., 1978) and a 10-minute free play period.
Parent sensitivity will be rated on a 5 point Likert scale from the play and reunion episodes.
Coded ratings on sensitivity and intrusiveness will be combined across intervals to create a composite maternal sensitivity score.
We hypothesize that compared to women in the active control condition, women in the treatment condition will show higher levels of maternal sensitivity at the 12-month postpartum assessment.
Higher scores indicate better outcomes.
|
12-months postpartum
|
Intimate Partner Violence at posttreatment
Time Frame: posttreatment
|
The Revised Conflict Tactics Scale (Straus, et al, 1996) will be used to assess the severity of psychological, physical, and sexual violence experienced by women in a dating, cohabiting, or marital relationship.
We hypothesize that compared to women in the active control condition that women in the treatment condition will have lower frequency of intimate partner re-victimization over time.
Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support.
Items cluster into five scales: physical assaults, psychological aggression, sexual coercion, injury, and negotiation techniques.
Respondents report frequency on a scale of 1 = once [since the last interview] to 6 = more than 20 times [since the last interview].
Higher scores indicate worse outcomes.
The current study used the frequency scoring method for the CTS2, which recodes the scale to represent the midpoints of each range with a possible total range of 0 to 825 events.
|
posttreatment
|
Intimate Partner Violence at 3-months postpartum
Time Frame: 3-months postpartum
|
he Revised Conflict Tactics Scale (Straus, et al, 1996) will be used to assess the severity of psychological, physical, and sexual violence experienced by women in a dating, cohabiting, or marital relationship.
We hypothesize that compared to women in the active control condition that women in the treatment condition will have lower frequency of intimate partner re-victimization over time.
Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support.
Items cluster into five scales: physical assaults, psychological aggression, sexual coercion, injury, and negotiation techniques.
Respondents report frequency on a scale of 1 = once [since the last interview] to 6 = more than 20 times [since the last interview].
Higher scores indicate worse outcomes.
The current study used the frequency scoring method for the CTS2, which recodes the scale to represent the midpoints of each range with a possible total range of 0 to 825 events.
|
3-months postpartum
|
Intimate Partner Violence at 12-months postpartum
Time Frame: 12-months postpartum
|
he Revised Conflict Tactics Scale (Straus, et al, 1996) will be used to assess the severity of psychological, physical, and sexual violence experienced by women in a dating, cohabiting, or marital relationship.
We hypothesize that compared to women in the active control condition that women in the treatment condition will have lower frequency of intimate partner re-victimization over time.
Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support.
Items cluster into five scales: physical assaults, psychological aggression, sexual coercion, injury, and negotiation techniques.
Respondents report frequency on a scale of 1 = once [since the last interview] to 6 = more than 20 times [since the last interview].
Higher scores indicate worse outcomes.
The current study used the frequency scoring method for the CTS2, which recodes the scale to represent the midpoints of each range with a possible total range of 0 to 825 events.
|
12-months postpartum
|
Infant Development at 3 months of age
Time Frame: 3-months
|
Infant development (cognitive, language, socioemotional) will be evaluated using The Bayley Scales of Infant and Toddler Development and The Ages and Stages Questionnaire - 3, which are a standardized measures.
We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show better developmental outcomes.
Further, we hypothesize that infant development at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months.
The Bayley is a standardized measure and within each domain an average score is 100.
Higher scores indicate better outcomes.
On the Ages and Stages Questionnaire, scores for each subdomain (Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social) range from 0 to 60.
|
3-months
|
Infant Development at 12 months of age
Time Frame: 12-months
|
Infant development (cognitive, language, socioemotional) will be evaluated using The Bayley Scales of Infant and Toddler Development and The Ages and Stages Questionnaire - 3, which are a standardized measures.
We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show better developmental outcomes.
Further, we hypothesize that infant development at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months.
The Bayley is a standardized measure and within each domain an average score is 100.
Higher scores indicate better outcomes.
On the Ages and Stages Questionnaire, scores for each subdomain (Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social) range from 0 to 60.
|
12-months
|
Infant Regulation at 3 months of age
Time Frame: 3-months
|
At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in the Still-Face Paradigm (Tronick et al., 1978).
Infant affect, which includes a combination of vocal and facial reactions, will be rated on a second-by-second basis across all three episodes of the SFP and free play.
A 7 point Likert scale ranging from a -3 (screaming) to +3 (laughing intensely) will be used.
Affect data are reduced to the proportion of time infants spend in negative and positive affect states (Braungart-Rieker et al., 2014).
We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show more positive affect over time, at 3 and 12 months of age.
Further, we hypothesize that infant affect at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months.
Higher scores indicate better outcomes.
|
3-months
|
Infant Regulation at 12 months of age
Time Frame: 12-months
|
At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in the Still-Face Paradigm (Tronick et al., 1978).
Infant affect, which includes a combination of vocal and facial reactions, will be rated on a second-by-second basis across all three episodes of the SFP and free play.
A 7 point Likert scale ranging from a -3 (screaming) to +3 (laughing intensely) will be used.
Affect data are reduced to the proportion of time infants spend in negative and positive affect states (Braungart-Rieker et al., 2014).
We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show more positive affect over time, at 3 and 12 months of age.
Further, we hypothesize that infant affect at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months.
Higher scores indicate better outcomes.
|
12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in social support from baseline to posttreatment
Time Frame: posttreatment
|
Women's sources of maternal support will be assessed with the Lubben Social Network Scale-Revised(Lubben & Gironda, 2003), which examines the level of perceived support from family networks and friendship networks.
We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher social support over time.
Further, we hypothesize that social support will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting.
Total scores range from 0 to 90.
Higher scores indicate better outcomes.
|
posttreatment
|
Change in social support from baseline to 3-months postpartum
Time Frame: 3-months postpartum
|
Women's sources of maternal support will be assessed with the Lubben Social Network Scale-Revised(Lubben & Gironda, 2003), which examines the level of perceived support from family networks and friendship networks.
We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher social support over time.
Further, we hypothesize that social support will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting.
Total scores range from 0 to 90.
Higher scores indicate better outcomes.
|
3-months postpartum
|
Change in social support from baseline to 12-months postpartum
Time Frame: 12-months postpartum
|
Women's sources of maternal support will be assessed with the Lubben Social Network Scale-Revised(Lubben & Gironda, 2003), which examines the level of perceived support from family networks and friendship networks.
We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher social support over time.
Further, we hypothesize that social support will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting.
Total scores range from 0 to 90.
Higher scores indicate better outcomes.
|
12-months postpartum
|
Change in empowerment from baseline to posttreatment
Time Frame: posttreatment
|
The Personal Progress Scale-Revised (Johnson, Worrell, & Chandler, 2005) will be used to examine women's attitudes and behaviors associated with increased empowerment and well-being.
We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher empowerment over time.
Further, we hypothesize that empowerment will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting.
Scores range from 0 to 196; higher scores indicated better outcomes.
|
posttreatment
|
Change in empowerment from baseline to 3-months postpartum
Time Frame: 3-months postpartum
|
The Personal Progress Scale-Revised (Johnson, Worrell, & Chandler, 2005) will be used to examine women's attitudes and behaviors associated with increased empowerment and well-being.
We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher empowerment over time.
Further, we hypothesize that empowerment will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting.
Scores range from 0 to 196; higher scores indicated better outcomes.
|
3-months postpartum
|
Change in empowerment from baseline to 12-months postpartum
Time Frame: 12-months postpartum
|
The Personal Progress Scale-Revised (Johnson, Worrell, & Chandler, 2005) will be used to examine women's attitudes and behaviors associated with increased empowerment and well-being.
We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher empowerment over time.
Further, we hypothesize that empowerment will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting.
Scores range from 0 to 196; higher scores indicated better outcomes.
|
12-months postpartum
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-03-5260
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Depression
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
Sage TherapeuticsCompletedSevere Postpartum DepressionUnited States
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
Gazi UniversityCompletedPostpartum Depression | Postpartum AdaptationTurkey
-
British Columbia Children's HospitalActive, not recruiting
-
University of RochesterMae Stone Goode FoundationCompletedPostpartum Depression | Postpartum AnxietyUnited States
-
Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
Clinical Trials on Pregnant Moms' Empowerment Program
-
University of Notre DameUniversity of MemphisCompletedDepression | Parenting | Child Behavior | Posttraumatic Stress Disorder | Violence | Infant DevelopmentUnited States
-
Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Macmillan Research Group UKCompletedAbuse Physical Battered Woman SyndromeIndia
-
Yale UniversityNational Diaper Bank Network; Clifford Beers Clinic; City of New Haven- Health... and other collaboratorsTerminated
-
Nova Scotia Health AuthorityRecruiting
-
Brittany L SmallsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of MichiganActive, not recruitingChild Mental DisorderUnited States
-
Brittany L SmallsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of Southern CaliforniaThe Leona M. and Harry B. Helmsley Charitable TrustCompletedType 1 Diabetes MellitusUnited States