Clinical Research Directory

MIO-CPP to Improve the Well-being, Permanency, and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties, and Affected by Maternal Substance Use

The goal of the project is to improve child well-being, permanency, and safety, and reduce the risk for involvement in the child welfare system for families with children pre-birth to five years who are affected by parental substance use disorders (SUD). The project will integrate with SUD treatment programs for pregnant/parenting women and their children and provide an evidence-based therapeutic model, Mothering from the Inside Out (MIO) and Child Parent Psychotherapy (CPP). MIO-CPP promotes the development of parental reflective functioning and strengthen parent/child attachment. The project will also examine the role of Certified Recovery Specialists (CRS) to provide case management services to parents during their enrollment in therapy. MIO is an individual, manualized, psychotherapeutic intervention designed to promote parental reflective functioning in mothers who are in treatment for SUDs and/or other mental health problems, and caring for a child in-utero through five years old. CPP is typically offered through weekly sessions with the mother-child dyad that last 1 to 1.5 hours. This is a single-arm effectiveness study to assess effectiveness and efficiency of MIO-CPP on parent and child outcomes including evidence-based model efficiency, parent/caregiver well-being, child well-being, and family well-being. The study will take place in two phases. All eligible caregivers will receive MIO-CPP. Participants enrolled during Phase 2 of the study will additionally receive an exploratory enhanced intervention intended to increase client engagement with MIO-CPP. The recruitment for study participants will stop when 320 mother-child dyads have enrolled in the study. Participants will include mother-child dyads from families involved with residential SUD treatment programs serving women and children in Philadelphia and Bucks counties. In Bucks County we will receive referrals from Libertae Inc. in Bensalem, Pennsylvania (PA). In Philadelphia, we will receive referrals from Gaudenzia Hutchinson Place and the Gaudenzia Winner Program. Data collection from participants will occur at four time points during the study: 1) when participants are enrolled; 2) 3 months following enrollment; 3) 6 months following enrollment; and 4) 9 months following enrollment or when the participant ends their participation in weekly therapy sessions if sooner than 9 months following enrollment. Study measures will include: 1) Parent/Caregiver Well-being: a) maternal reflective functioning, b) depression, anxiety, and trauma-related symptoms, c) parental substance use and move toward recovery; d) parenting stress; e) parent-child relationship; 2) Child Well-being: a) behavior problems, b) executive functions; c) socialization skills; 3) Family Well-being: a) child welfare involvement, b) reunifications. As part of this study, investigator will acquire administrative data about the safety and permanency of children and adult recovery for all study participants. The Primary Investigator will request substance use treatment data from the City of Philadelphia Department of Human Services. The requested data elements will include whether the study child has a child welfare record, the types of allegations of abuse or neglect, and when the allegations occurred (from birth to present day). Additionally, investigators will request all available substance use treatment records will be requested for adults who are a part of a study case for the year prior to enrollment in the study to one year following their enrollment in the study.

A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers

The goal of this clinical trial is to evaluate whether a home-based mHealth intervention can improve adherence to the 24-Hour Movement Guidelines in preschool-aged children (3-4 years old) who currently meet 0 or 1 of the guidelines for physical activity, sedentary behavior, and sleep. The main questions it aims to answer are: * Can the intervention increase the proportion of children meeting all three 24-Hour Movement Guidelines (physical activity, screen-time, and sleep)? * Is the intervention feasible for parents to implement, as measured by a parent feedback survey? Researchers will compare an intervention group to a waitlist control group to assess whether the intervention leads to increased guideline adherence. Parents and Participants: * Children will wear an accelerometer to track physical activity and sleep patterns. * Parents will use a mobile app that delivers weekly lessons and behavior-related goals to encourage healthy movement behaviors in their children. * Parents will complete questionnaires on their child's movement behaviors and development at baseline, 6 weeks, and 12 weeks. * Additionally, children will undergo motor skills assessments, and parents will provide feedback on cognitive development and behavioral changes.

Research on Optimizing the Use of Technology With Education

Consistent use of continuous glucose monitors (CGM) has the potential to improve glycemic control and related type 1 diabetes (T1D) health outcomes, however young adolescents with T1D are the least likely age group to begin and sustain use of CGM. The proposed study will conduct a feasibility trial of a behavioral intervention designed to optimize use of CGM in adolescents specifically targeting underrepresented populations in diabetes technology research.

CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood

Disparities in health begin in early childhood. Early life experiences influence brain development and have significant implications on future health and developmental outcomes. Low-income children are at greater risk of developmental delays in large part due to a lack of an enriched environment. Disparities in early childhood development increase risk for stunted academic achievement throughout the life course. Primary care is a universal exposure in early childhood and therefore is also a significant entry point for promoting optimal child development. There is a need to provide effective, low-cost, and scalable interventions in primary care to support early childhood development.The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. To date, there is no evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement. The intent of this study is to determine the effectiveness of the CenteringParenting intervention on school readiness in early childhood, as measured by language development at 24 months, (in addition to health care utilization, child routine care maintenance, parenting stress, caregiver behaviors and attitudes).

Dyad Plus Effectiveness/Feasibility

The purpose of this research is to determine the effectiveness of a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.

Dino Study: Daily Intervention-based Research on Nurturing Opportunities in Young Children

The goal of this clinical trial is to evaluate the effectiveness of the Incredible Years Dinosaur Program in children aged 4 to 8 years with conduct problems. The main questions it aims to answer are: * Does participation in the Dinosaur Child Program lead to greater improvements in children's emotional, social, and cognitive functioning, and reductions in externalizing behavior compared to a waitlist control group? * Does the intervention reduce emotional variability and daily behavior problems as captured through daily diary assessments? * Does the intervention improve daily parent-child dynamics, including reduced emotional escalation and more shared positive affect? Researchers will compare children in the intervention group to those in the waitlist control group to see if the program leads to better emotional regulation, fewer behavior problems, and improved parent-child interactions. Participants will: * Be randomly assigned to either the intervention or waitlist control group (1:1) Receive 18 weekly small-group sessions (if in the intervention condition) using the Incredible Years Dinosaur Program * Complete daily diaries with their parent using the m-Path app during a 20-week period (baseline, intervention, follow-up) * Complete standardized pre- and post-intervention assessments via parent, teacher, and child reports

Mobile Prenatal Education for Expectant Fathers and Its Effects on Bonding, Stress, Breastfeeding and Marital Satisfaction

The aim of this interventional clinical trial is to assess whether a mobile-based antenatal education programme for expectant fathers has a positive effect on father-infant bonding, stress levels, and breastfeeding attitudes. The study aims to answer the following main questions: Does participation in a mobile-based prenatal education programme strengthen fathers' emotional bonds with their babies? Does the education reduce fathers' stress levels during the prenatal and postnatal periods? Does it increase the father's knowledge and supportive attitude towards breastfeeding? Researchers will compare whether there are measurable differences in attachment, stress, and breastfeeding attitudes between the intervention group (fathers receiving mobile-based education) and the control group (fathers receiving standard routine information). Participants: Will complete pre- and post-intervention questionnaires assessing attachment, stress, and breastfeeding attitudes. The intervention group will have access to a six-module mobile application covering topics such as infant care, nutrition, sleep routines, health and safety, emotional development, and daily care practices. The study will be conducted with fathers aged 19-65 who became fathers within the last month and voluntarily agreed to participate.

Talk Parenting Education Program II

The goal of this clinical trial is to learn whether Talk Parenting, a voice-based program delivered through an Amazon Echo Dot (Alexa), can help parents and caregivers of children ages 3-5 years improve challenging bedtime and morning routines. The main questions it aims to answer are: Does using Talk Parenting improve families' bedtime and morning experiences and children's sleep/wake habits? Does using Talk Parenting improve parents' routine-related parenting practices and confidence, strengthen the parent-child relationship, and reduce children's behavior problems and parents' stress? Researchers will compare families who receive Talk Parenting right away to families who wait 6 weeks to receive the program (a waitlist control group receiving usual services during the wait). Participants will: Complete online questionnaires at the start of the study and again about 6 weeks later (and a follow-up questionnaire later in the study). Receive a pre-configured Amazon Echo Dot (to keep) and instructions to use Talk Parenting routines at home, including a bedtime routine, a brief calming routine, and a morning routine (enabled after the first 2 weeks).

Supporting Parents in Affirming Their Children's Experiences of Stigma

The purpose of this study is to develop and test two brief online writing interventions to improve parental acceptance of sexual and gender minority youth (SGMY) in the Southeast United States.

Parenting-STAIR Modular for Military Fathers and OCONUS Families

The goal of this clinical trial is to learn if a family-based treatment called Parenting-STAIR-Modular (PSTAIR-M) can help military parents recover from trauma, strengthen emotion regulation skills, and improve parent-child relationships. Participants will be trauma-exposed active-duty Service Members (SM) or their spouses who screen positive for PSTD and/or depression, and one identified child (ages 2-10). The main questions it aims to answer are: 1) Does PSTAIR-M reduce parental PTSD and depression symptoms, lower parenting stress, and improve child behavior compared to treatment-as-usual?; and 2) Is PSTAIR-M feasible and acceptable when delivered to military families stationed overseas? Researchers will compare PSTAIR-M to treatment-as-usual (TAU) to see if PSTAIR-M leads to greater improvements in parental PTSD, depression, parenting stress, emotion regulation, child maltreatment risk, and child behavior than usual care. Participants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded.

A Trial of Two Universal Programs for Parents of Teenagers

Group-based and internet-delivered parenting programs may help parents improve their communication and relationships with their children. However, relatively little is known about how well such programs work for parents of adolescents, because most previous studies have focused on younger children or on families selected because of elevated risk. This study evaluated two universal preventive parenting programs for parents of adolescents: the group-based ABC-Teen program and the internet-delivered ParentWeb program. Both programs were developed in Sweden and aim to promote adolescent well-being by strengthening parenting practices and parent-adolescent relationships and reducing negative communication. Families were randomized to ABC-Teen, ParentWeb, or a waitlist control condition. The sole primary outcome was parent-reported adolescent mental health problems, measured using the Strengths and Difficulties Questionnaire Total Difficulties score. Secondary outcomes included parental mental health and stress, parenting behaviors and parental self-efficacy, parent-adolescent and family relationships, adolescent school adjustment and substance use, and outcomes reported by participants in an optional adolescent survey. Parent and adolescent assessments were conducted at baseline, 4 months, and 12 months. After completion of the 4-month assessment, families assigned to the waitlist were offered their choice of ABC-Teen or ParentWeb. Consequently, comparisons with the waitlist were restricted to the period from baseline to 4 months, whereas longer-term analyses compared ABC-Teen with ParentWeb.

Cancer Parenting Program for the Enhancement of the Quality of Life of Patients With Advanced Cancer and Their Children

This trial examines the usefulness of two educational programs for parents with late-stage cancer who have a 5 - 17 year old child. The programs are designed to enhance the quality of the parent-child relationship and add to the parent's confidence in managing the impact of their cancer on their child. Educational programs may reduce anxiety and depression and improve the well-being and quality of life of parents with advanced cancers and their children. Recruitment occurs nationally via referral to the Fred Hutch/University of Washington Cancer Consortium team.

Pilot Study of Parent Training With Role-plays in Virtual Reality for Parents of Children With Behavior Problems

The main aim of this pilot trial is to evaluate preliminary effects and feasibility of a new parent training program for parents of children aged 8-16 years with disruptive behavior (e.g., angry, aggressive or defiant behavior). The parent training program is based on cognitive behavioral therapy (CBT) and includes practicing of skills in virtual reality (VR). The main questions the project aims to answer are: * What are the preliminary effects of the CBT-VR parent training program? * What is the level of parent engagement in the CBT-VR parent training program? * What are the experiences of parents and therapists of the CBT-VR parent training program? The CBT-VR parenting program is delivered at clinics during individual sessions. Parents will answer quantitative measurements before, during, and after treatment. Within-group analyses will be conducted to examine experiences and preliminary effects of the program. Parents and clinicians are also asked to participate in a qualitative interview after the program has ended.

Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children

The goal of this study is to assess Parenting STAIR Modular (PSTAIR-M), a promising and innovative intervention for military-connected mothers (MCM) who have experienced trauma and their young children (ages 2-10). PSTAIR-M aims to help mothers manage the strong feelings that sometimes happen after experiencing something scary or stressful, as well as to better connect with their children and manage their behavior effectively. The main questions the study aims to answer are: from pre-treatment to post-treatment 1) Does PSTAIR-M reduce maternal PTSD and/or depression symptoms?, and 2) Does PSTAIR-M improve parental functioning? Participants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded. Participants may also be invited to participate in an optional, 30-minute online one-on-one qualitative interview, which would be audio and video recorded and would cover participants' experiences with the intervention, the clinic sites, and their providers.

Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions

Studies underline both the importance of the link and contact that occurs in the earliest days of life and the need to involve parents early with their premature child. However, the impact of parental nutrition on the later active nutrition and on the quality of parent-child interactions is currently unknown. PREMIAM study investigates whether active parental participation in enteral nutrition improves the interactions between the infant and his parents, making them more sensitive to their baby's signals and promoting their relational adjustment.

Relationship Enhancement Digital Game

The purpose of this study is to test a new digital game. Specifically, this study will aim to evaluate a digital game prototype designed to facilitate playful interactions between parents and children. The prototype will incorporate activities grounded in relationship enhancement principles. Additionally, this study will check how well using digital tools helps build strong connections, makes people get along better, and boosts parents' confidence and parenting skills.

Child-Parent Psychotherapy - a Feasibility Study for Children in Foster Care

Children in foster care have an increased risk of exposure to adverse experiences during childhood and across the lifespan. In current studies of interventions children in foster care are often excluded, or they are too few to be included in statistical analyses of outcomes. As a consequence, knowledge on feasibility of treatment methods for some of the most exposed and maltreated children in society is sparse. Child-Parent Psychotherapy (CPP) is an intervention for children 0-6 years who have been exposed to adverse and traumatic events. CPP is currently being implemented in Sweden. The aim of this study is to investigate the feasibility of CPP for children in foster care.

Promoting Co-Parenting and Reducing Hazardous Drinking in New Families

This study aims to understand if a parenting program that helps couples learn to parent as a team and maintain a healthy lifestyle, such as maintaining safer levels of alcohol use, promotes parent and child health and well-being. Programs will be delivered prenatally and postnatally and will include both group classes and individualized sessions. A comprehensive assessment is administered during pregnancy and then at 6 and 12 months of child age. It is hypothesized that targeting intervention during the naturally motivating transition to parenthood may not only provide opportunities for long lasting behavioral change for parents, but also initiate a cascade of protective processes that ultimately reduce risk for negative emotional and behavioral outcomes for children.

Family Telehealth Project for Foster Care Youth

The purpose of this research is to adapt and evaluate the efficacy of an existing family based intervention to be delivered via telehealth to child welfare-involved (CWI) youth and their caregiver of origin.

Evaluating Stress Management Strategies Within the School Readiness Parenting Program

The goal of this randomized study is to learn if adding three additional parent training sessions (focused on alleviating parental stress) to an already well-established treatment (School Readiness Parenting Program \[SRPP\]) in improving outcomes up to 6- and 12-months later for families of children with disruptive behavior disorders. The main questions it aims to answer are: The primary objective of this protocol is to evaluate the effects of three additional cognitive behavioral therapy (CBT) based parent training sessions to the SRPP to reduce parent stress and improve parent-child interactions. The secondary objective of this protocol is to evaluate the behavioral, emotional, and physical health-based functioning among young children with ADHD. Researchers will compare families who receive the SRPP alone to families who receive the SRPP + the three additional CBT focused sessions. Parents will be sent surveys to complete prior to the baseline assessment via REDCap (online). Parent and child participants will undergo 2 hours of baseline assessments evaluating behavioral, cognitive, and academic functioning as well as parent-child interactions. Parents will provide contact information for their child's teacher and the teacher will sent three surveys to complete online via REDCap.

Examine the Feasibility and Acceptability of Project Support

In this study, the investigators will conduct a proof-of-concept pilot trial of delivering the Project Support Positive Parenting Module (Project Support) to n = 30 families waiting for trauma-focused services. Investigators hypothesize that Project Support will be feasible and acceptable as evidenced by benchmarks for recruitment, retention at post assessment, engagement, fidelity, and program satisfaction. Investigators will also explore trends on caregiver emotional support, parenting self-efficacy, and child mental health symptoms.

Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)

This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral therapy (CBT) sessions.

Sensory Optimization of the Hospital Environment

The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often applied in an inconsistent manner, reducing their benefit. Through a rigorous and scientific process, we have developed a structured multisensory intervention program, titled Supporting and Enhancing NICU Sensory Experiences (SENSE), which includes specific doses and targeted timing of evidence-based interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care. The interventions are based on the infant's developmental stage and are adapted based on the infant's medical status and behavioral cues. The multisensory interventions are designed to be conducted during each day of NICU hospitalization by the parents, who are educated and supported to provide them. The proposed work aims to determine the effect of multisensory interventions on parent mental health, parent-child interaction, brain activity (amplitude integrated electroencephalography), and infant developmental outcomes through age 2 years, with specific attention to language outcome.

Postpartum Intervention for Mothers With Opioid Use Disorders (R33)

Having met the milestones of the R61, this R33 is a 2-site, 2-group, pre/post RCT of mothers with OUD (n=\~80/group). We will test whether the beneficial pre-post changes in OUD mothers randomized to vMP exceed those of mothers assigned to Enhanced Usual Care (EUC) and via changes in Maternal Brain Neurocircuits.