Parenting Clinical Trials

This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), and/or chronic Lyme (CL) either during or before a prior pregnancy. Participants will complete quantitative surveys on topics such as their medical history, their child(ren)'s development, and demographic information. They will then participate in a qualitative interview where they will be asked about their experiences with pregnancy and with parenting their child(ren) in the context of their condition. Read Less

The purpose of the study is to evaluate early implementation outcomes of a positive parenting program, Child Adult Relationship Enhancement in Primary Care (PriCARE), in the foster care setting and to assess the efficacy of PriCARE in promoting positive parenting and increasing empathy among foster caregivers. Read Less

This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors. Read Less

Parents are children's primary role models, are food and physical activity gatekeepers, and create the structure/lifestyle environment within the home. Thus, parents strongly influence children's weight-related behaviors and have the opportunity to cultivate a "culture of health" within the home. Yet, there continues to be a dearth of evidence-based obesity prevention intervention programs, especially for families with children aged 6 to 11 years, commonly called the middle childhood years. The aim of the HomeStyles-2 online learning mode RCT is to determine whether this novel, age-appropriate, family intervention enables and motivates parents to shape their home environments and weight-related lifestyle practices (i.e., diet, exercise, sleep) to be more supportive of optimal health and reduced risk of obesity in their middle childhood youth more than those in the control condition. The RCT will include the experimental group and an attention control group who will engage in a bona fide concurrent treatment different in subject matter but equal in nonspecific treatment effects. The participants will be families with school-age children who are systematically randomly assigned by computer to study condition. The HomeStyles intervention is predicated on the social cognitive theory and a social ecological framework. The RCT will collect sociodemographic characteristics of the participant, child, and partner/spouse; child and parent health status; parent weight-related cognitions; weight-related behaviors of the parent and child; and weight-related characteristics of the home environment. Enrollment for this study will begin mid-2021.This paper describes these aspects of the HomeStyles-2 intervention: rationale; sample eligibility criteria and recruitment; study design; experimental group intervention theoretical and philosophical underpinnings, structure, content, and development process; attention control intervention; survey instrument development and components; outcome measures; and planned analyses. Read Less

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). Read Less

The goal is to examine the efficacy of the Parenting Action Plan (PAP), a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby. Read Less

The current study provides a unique opportunity to conduct a summative evaluation of the KEEP Connecting Kin (KEEP-CK) program by leveraging extant relationships with Oregon's Child Welfare System (CWS), Self-Sufficiency Program (SSP), and our community partners to address the needs of informal kinship families and the youth in their care. Specifically, a randomized "services-as-usual" (SAU) waitlist control design plus qualitative methods will be used to evaluate the immediate (post-intervention) and sustained (10 month) impacts of the KEEP-CK program on child, adult, and service utilization outcomes, and prevention of entry into the CWS. Read Less

Caregiver Skills Training (CST) is an evidence-based intervention for parents of young children with developmental disabilities that was developed through a collaboration between Autism Speaks and the World Health Organization. The intervention is typically offered by Facilitators who are trained and supervised by CST Master Trainers. This study seeks to use a remote training model to compare two training and supervision processes. One group, comprised of facilitators from rural settings, will be trained and supervised by two master trainers from the University of Pittsburgh using a remote training model. A second group, comprised of facilitators from an agency serving primarily low-income households and located near Pittsburgh, will be trained and supervised in a face-to-face manner. Both groups will initially receive ten 90-minute training sessions over a 2-month period and will subsequently receive 1 hour per week of supervision while conducting their first 12-session CST group. Outcome measures will include assessment of change in caregiver stress and didactic skills as well as improvement in each child's communication/social skills, functional skills, and overall behavior. We have also added an additional research question in which we compare face-to-face CST sessions with remote CST sessions. Read Less

Research suggests that one in eight children in the U.S. currently lives with a parent with a substance use disorder. Parents who misuse substances are at increased risk of using harsh and other negative parenting practices with their young children, who are more likely to face challenges with emotional and behavioral regulation and subsequently misuse substances themselves. There is thus an urgent need for evidence-based interventions to promote positive parenting skills in parents who misuse substances. Interventions must be convenient, non-stigmatizing, and accessible to parents with problematic substance use, who frequently face barriers to engaging with healthcare systems. Pediatric primary care is an ideal setting to offer a brief intervention for maladaptive parenting behaviors associated with parental substance use, as the vast majority of children under 5 access pediatric primary care at least annually and parents generally report high levels of trust in their child's pediatrician. The Family Check-Up (FCU) Online app, which was created specifically to promote positive parenting skills in parents with past or current substance misuse, is ideal for delivery to parents with pre-school age children in a pediatric primary care setting as it is brief, convenient, and delivered in a self-directed format that parents favor. The main objective of this pilot study is to test the feasibility and acceptability of the FCU-Online, a brief, app-based parenting intervention, for parents reporting lifetime problematic substance use in a pediatric primary care setting. In this study, investigators will partner with pediatric primary care providers to recruit parent participants, then evaluate feasibility and acceptability by systematically assessing parents' engagement with the FCU Online app. Engagement data from the app includes time spent in app overall and in each module, activities completed, and which modules were accessed. Investigators will also administer a consumer satisfaction survey, which will ask parents to report on their perceptions of the app (e.g., helpfulness, useability, and effects on parenting). To assess engagement in telehealth coaching sessions, investigators will use the following variables: number of telehealth sessions completed, length of session, content of sessions, and coaches' ratings of participant engagement in the session and barriers to using the app. Coaches will also rate participant engagement on a 3-point scale from "low" to "high." Lastly, investigators will conduct qualitative interviews with a sub-sample of participants to solicit additional feedback on the acceptability of the FCU Online, focusing particularly on the perception of acceptability within an integrated primary care context and stigma associated with endorsing substance use in this setting. A second aim of this study is to assess pediatric healthcare providers' perceptions and attitudes regarding the fit of the FCU Online with their practice settings as well as potential barriers to implementation. Through semi-structured focus groups and qualitative interviews with pediatric healthcare providers, investigators will assess provider- and practice-level factors that may facilitate or impede the implementation of the FCU Online in pediatric primary care settings. Read Less

This study evaluates feasibility and preliminary efficacy of a parent-based prevention program to promote social-emotional and lifestyle behavior health among 3- to 9-year-old children in families experiencing major stressors. Read Less

Montefiore Medical Center (in partnership with BronxWorks) is implementing a large-scope program to promote responsible fatherhood in the Bronx among low-income adult (18 years or older) fathers with non-custodial children (under the age of 24). The program, called HERO Dads (Healthy, Empowered, Resilient, Open Dads), will promote responsible fatherhood by enhancing relationship and anger-management skills and providing marriage education; providing skills-based parenting education, disseminating information about good parenting practices, and encouraging child support payments (in partnership with our local OCSE); and fostering economic stability by providing employment-related supports inclusive of job search, vocational skills training, job referrals, and job retention. Read Less

The overall goal of this study is to develop, adapt and evaluate an intergenerational prevention intervention, named "Wakȟáŋyeža (Little Holy One)," with Native American caregivers on a Northern Plains reservation and the caregivers' 2-to-5-year-old children. The intervention aims to: 1) reduce symptoms of historical trauma and everyday stress among parents/caregivers, 2) improve parenting, and 3) improve children's emotional and behavioral developmental outcomes to reduce future risk for suicide and substance use. Read Less