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50 active trials for Parent-Child Relations

A Behavioral Intervention to Promote Synchronous Mother-infant Interaction in Women With Childhood Adversity

Childhood adversity affects almost two-thirds of the US population, is a major risk factor for the leading causes of disease and increases US economic health burdens. Childhood adversity also alters biologic systems, such as the oxytocin hormone, that can affect attachment behavior. This innovative study has the potential to advance science and improve mother-infant interaction by testing an early life, home-based, multisensory behavioral intervention (called ATVV), targeting the oxytocin system, to promote synchronous early mother-infant interaction, especially critical for mothers who have experienced childhood adversity. This two-group randomized clinical trial will test the ATVV's effect on oxytocin system function and quality of mother-infant interaction. The investigators will enroll 250 first-time healthy mothers carrying a single baby who have a history of childhood adversity, and obtain baseline data in their third trimester of pregnancy. Soon after birth (before hospital discharge), mothers (and babies) who continue to be eligible are randomized into the intervention group and taught to give ATVV daily for 3 months, or randomized into the Attention Control education group and taught safe infant care. After birth, the investigators check-in frequently with mothers through weekly phone calls. There are 3 study visits at 1, 2 and 3 months after birth that include survey questions and collection of maternal blood and infant saliva. Mothers and babies are also video-recorded at 3 months after birth for 4 minutes to assess mother-infant interaction. The investigators follow-up with a phone call at 6 months after birth. While both groups will benefit from the content and attention the investigators give mothers, the investigators hypothesize that, compared to the education group, mothers and infants in the intervention group will have improved oxytocin system function and more synchronous mother-infant interaction.

Start: July 2021

ODISEA 2.0 Video-feedback Intervention to Promote Parenting Skills

This is a study protocol of a randomized controlled trial, which aims to validate the effectiveness of the ODISEA 2.0 Video-feedback intervention compared to a non-intervention group. While this methodology can be used with caregivers of children from 0 to 8 years, in this first study the sample will be caregivers and children from 10 to 47 months. The data collection will be through a pre post evaluation using the parenting skills questionnaire (E2P V2), parental stress index - short form (PSI-SF), and assessment of interaction videos with the Adult Sensitivity Scale (E.S.A) and PICCOLO methodology. Additionally, caregivers will be screened for ACES and with a sociodemographic characterization questionnaire. The primary outcome aims to measure the effectiveness of the intervention within the parenting skills of the caregivers. The secondary outcomes will be to assess parental self-efficacy, parenting stress, parenting practices, parental sensitivity, and implementation fidelity compared to accumulated risk.

Start: June 2021

Epigenetics and Protective Factors in the Preterm Infant

Preterm infants (PT) spend their first weeks of life in the Neonatal Intensive Care Unit (NICU) where they are exposed to unfavorable conditions with different effects on child development including long-term alterations in epigenetic regulation (DNA methylation). Recent studies document that these epigenetic changes are associated with behavioral modifications, such as altered stress reactivity at 3 months and 4 years. A growing number of studies suggest that protective Developmental Care (DC) procedures (e.g., breastfeeding, skin-to-skin contact (SSC), maternal holding) positively impact neurophysiological and behavioral adaptation of PT with long-term effects. Additionally, a neuro-imaging study reported that parental support in the NICU is associated with improved brain connectivity. While in term (FT) infants, parental interpersonal touch (breastfeeding, affectionate touch) is associated with reduced methylation and activation of specific brain areas associated with affective interpersonal touch, to date no study has investigated whether DC practices and maternal care in NICU (specifically, SSC) buffer methylation and support the brain response to affectionate physical touch in PT. The present study investigates the association between DC procedures in NICU, DNA methylation, and brain responses to affectionate touch, investigated through the use of MRI, at 2 months of age (corrected for prematurity), controlling for: (1) birth status (PT vs FT); (2) the duration of SSC during the NICU stay; (3) parental affectionate touch in the home environment and during mother-child interaction.

Start: January 2019

Evaluation Study of Talk Parenting Skills

After development of the prototype Bedtime Routine module of the Talk Parenting program, the investigators will evaluate its feasibility and initial efficacy in a within-subjects pre-post design study. Through recruitment partner agencies, the investigators will recruit a sample of 52 at-risk families (52 primary parents, 52 target children, and 34 second parents). Primary parents will be assessed at enrollment via online an questionnaire, then provided an Amazon Echo Dot and asked to use the Bedtime Routine module for 6 weeks. They will then be re-assessed with the online questionnaire at 6 weeks (at treatment completion).

Start: September 2021

HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity

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.

Start: July 2021

Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants

Early developmentally-based behavioral intervention has well-established positive effects and is recommended as the standard of care to support early brain maturation, health, and development. However, few neonatal intensive care units (NICUs) provide this early intervention. H-HOPE (Hospital to Home: Optimizing the Preterm Infant's Environment) has established efficacy, and has a standardized protocol, making it ready for widespread implementation. The infant-directed component of H-HOPE provides Auditory (voice), Tactile (moderate touch massage), Visual (eye to eye), and Vestibular (rocking) stimulation starting when infants are ready for social interaction. The parent-directed component of H-HOPE includes participatory guidance and support to help parents engage with infants in the NICU and the transition to home. In this NIH-funded research, H-HOPE improved growth, developmental maturity and mother-infant interaction, and reduced initial hospitalization costs and acute care visits through 6-weeks corrected age. This research tests whether H-HOPE can be implemented and sustained in five diverse NICUs, using a Type 3 Hybrid design to evaluate both implementation processes and effectiveness. The specific aims are to: 1) Identify the degree of implementation success; 2) Evaluate the effectiveness of H-HOPE for infants, hospital costs from H-HOPE enrollment until discharge, and parents, compared to a pre-implementation comparison cohort; and 3) Determine influences (facilitators and barriers) associated with implementation success and H-HOPE effectiveness, guided by the Consolidated Framework for Implementation Research (CFIR). An incomplete stepped-wedge design guides staggered roll-out for five clinical sites. Each NICU completes the CFIR implementation steps (Planning and Engaging, Executing, and Reflecting and Evaluating), followed by 6 months of Sustaining. For Aim 1, degree of implementation success is determined every two months as Sustainability (still offering H-HOPE), Reach (% of eligible parent/infant dyads receiving H-HOPE) and Degree of Implementation (mean H-HOPE services received per parent-infant unit) (primary implementation outcomes). For Aim 2, effectiveness is analyzed using generalized linear mixed models for infant, cost, and parent outcomes (primary outcomes: infant growth at discharge and acute care visits from discharge to 6-weeks corrected age). Propensity score analysis is used to make the pre- and post-implementation comparable. For Aim 3, a mixed methods analyses is used to identify influences from H-HOPE records and interviews that are associated with implementation success and effectiveness at each site and across sites. This is the first time implementation in a NICU is guided by the evidence-based CFIR framework, and results will make a major contribution to implementation science. This study will produce an evidence-based implementation strategy and Toolkit to disseminate nationwide. Widespread H-HOPE implementation will make a significant change in clinical practice and improve preterm infant health and health care costs.

Start: November 2020

Skin-to-skin Contact in Neonatal Intensive Care Unit (NICU), Caregiving Touch and Neural Correlates of Slow Stroking Touch in Preterm Infants

Preterm (PT) infants spend their first weeks of life in Neonatal Intensive Care Unit (NICU) where receive little affective physical contact, which plays a crucial role in brain development. Evidence indicates that skin-to-skin contact (SSC) has a positive effect on infants' neurophysiological and behavioral adjustment to postnatal life. Moreover, caregiving touch during early interactions is related to sensitive caregiving behavior, which in turn is associated with brain connectivity in full-term (FT) infants. Despite the importance of both SSC and caregiving touch for infant development little is known about the neural correlates of early physical contact in PT infants. Using MRI the project aims to investigate the association between brain responses to gentle skin stroking at 2 months examining the effects of: (1) the birth status (PT vs. FT); (2) the duration of SSC in NICU; (3) the caregiving touch in the home environment and during mother-infant interaction. The investigators hypothesized: (1) differences in the brain responses in the above mentioned ROIs to gentle skin stroking, a type of tactile stimulus associated with affectionate touch and social interaction26, between FT infants and PT infants: (2) that above mentioned putative differences would be mitigate by duration of SSC during the NICU in PT infants; (3) an association between CT/sensitive caregiving behaviors both in the home environment and during face-to-face interaction and brain response in the above mentioned ROIs to gentle skin stroking in PT and FT infants.

Start: December 2019

Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges

The goal is to pilot a parent-mediated intervention for feeding challenges in children with autism building on recent research and current successful models already being used. A parent-mediated intervention would primarily occur in the home environment, working with the parent to establish goals and implement the intervention based on their child's specific needs.

Start: February 2017

BRIGHT Coaching Program for Families

Children with, or at elevated risk for, brain-based developmental disabilities can experience lifelong consequences and challenges throughout their development. In particular, preschool years (3-6 years of age) can be stressful as families wait to get services and care for their child. Nationally and internationally, service delivery models during this critical period are not standardized, and differ within and across provinces and across patient conditions, leading to long wait times, service gaps and duplications. This study has two main hypotheses: A standardized approach to "coaching" (i.e. coach + online education tools + peer support network) is feasible in the real-life context, and acceptable to caregivers and can be delivered across multiple sites in urban/suburban/rural settings. A standardized approach to "coaching" enhances parental health (parents' empowerment and sense of competence, quality of life, and minimizes parenting stress), family health care experience (care coordination experience and process of care) at similar health care cost (economic analysis), when compared to usual and locally available care.

Start: August 2018

A Scaleable Video Coaching Intervention for Opioid-using Mothers

This study will adapt and evaluate a novel, innovative, and highly scalable parenting intervention that employs video coaching to target responsive parenting, Filming Interactions to Nurture Development (FIND), among women who have been referred to or are in treatment for opioid misuse/addiction.

Start: February 2021

Trial of Transition to Parenthood Program for Couples

This is a research study to evaluate the effectiveness of the Family Foundations program and to better understand how families cope with having a new baby. The research questions include: What is the effectiveness of the Family Foundations program? How do families cope with having a new baby?

Start: June 2008

Systematic Review of Parents' Stress and Feeding Styles and Practices

Parents' mental health contributes to their feeding practices how they perceive and respond to their children's behavior. Suboptimal feeding practices may promote dysfunctional eating behaviours in children and contribute to children's weigh. The purpose of this review is to identify existing literature on the association between parents' stress and their feeding styles and practices

Start: June 2020

Therapist Education and Massage for Parent Infant-Outcomes

The Therapist Education and Massage for Parent-Infant Outcomes program is evidence-based and includes infant massage, physical therapy interventions including developmental support and play activities to promote infant behavioral-motor development, principles of family-centered care, and multiple modes of educational delivery to enhance parent retention of knowledge, parent-infant bonding, and confidence in continuing physical therapy interventions after discharge.

Start: November 2019

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.

Start: January 2021

The Sugira Muryango PLAY Collaborative

The Research Program on Children and Adversity (RPCA) has successfully grown its evidence-based home-visiting program-Sugira Muryango (SM)-in Rwanda, as policies and programs aligned with the Rwandan social protection system have evolved. The current study submission seeks to test an evidence-based implementation strategy, the PLAY Collaborative, to engage local stakeholders and frontline providers and supervisors to ensure quality improvement and sustainability of Sugira Muryango and to repeat our previous intervention to include Ubudehe 1 families with children 0-36 months in Nyanza, Ngoma, and Rubavu Districts in Rwanda.

Start: April 2021

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).

Start: February 2019

Effectiveness of 'Supportive Parenting App' on Parental and Newborn Outcomes

The Supportive Parenting App is a theory-based perinatal educational intervention for couples administered through a mobile application. The intervention comprise of knowledge-based content, informational videos and audio, discussion forum, peer volunteer chat group, and a FAQ expert advice section. The aims of the study are to: develop theory-based supportive parenting App (SPA) intervention for both first-time and experienced parents across perinatal period examine its effectiveness on parental outcomes: including maternal depression at 12 months postpartum (primary outcome), paternal depression, parental anxiety, parenting self-efficacy, help - seeking behavior (social support), parental bonding and parenting satisfaction (secondary outcomes); and new-born outcomes: physical, social and emotional developments (secondary outcomes) evaluate SPA's cost-effectiveness as compared to standard perinatal care across major restructured hospitals, and examine the perceptions of parents in receiving this intervention. When compared with those in the control group receiving standard care: parents receiving SPA intervention will have better- emotional well-being (reduced depression and anxiety);parenting self-efficacy; social support; bonding and satisfaction. new-borns of parents receiving SPA will have better physical, social and emotional development It will be more cost-effective to provide SPA than the standard care

Start: March 2020

Project PEAK: Early Intervention for ADHD

Parent education is an effective and relatively cost efficient approach for reducing child behavior problems. Research, however, suggests that the effectiveness of parent education is mitigated by parent attendance and parent implementation of intervention strategies. That is, low attendance at parent education sessions is associated with limited intervention effects. Therefore, it is critical to identify strategies to enhance parent engagement. A previous pilot randomized controlled trial of a parent education program (Behavioral Parent Education; BPE, specifically Promoting Engagement for ADHD pre-Kindergartners [PEAK]), found that both face-to-face (F2F) and online BPE resulted in high levels of parent engagement and child behavior improvements. However, results need to be replicated in a full scale efficacy trial with a larger, diverse sample to provide more reliable estimates of relative effect sizes for parent and child outcomes and to evaluate the extent to which parent and child behavior changes are maintained after BPE has ended. In the current randomized controlled trial, the investigators intend to apply What Works Clearinghouse group design standards to examine the efficacy of two forms of delivery of BPE (F2F and online) relative to a wait-list control condition in a sample of 180, 3- to 5-year old children with clinically significant symptoms of ADHD. The objective is to: (a) extend findings from the pilot investigation to a large, diverse sample; (b) examine maintenance of effects; (c) identify moderators and mediators of treatment outcome, especially the degree to which these may differ for F2F vs. online treatment delivery; and (d) assess cost and cost-effectiveness of the two PEAK delivery formats.

Start: September 2020

Literacy Promotion Using Automated Hovering

The purpose of this study is to incorporate behavioral economics approaches to determine whether 3 novel interventions of varying intensity improve the frequency of parent-child reading behaviors among low-income families. Participants will be randomized to comparative groups to test the effects of automated hovering approaches on frequency of parent-child shared reading. Investigators long-term goal is to test the effects of these approaches to promote child language and socio-emotional development.

Start: October 2020

INFANT HEALTH- Promoting Mental Health and Healthy Weight in Infancy Through Sensitive Parenting

Mental health problems and overweight often co-occur, they have their origin in early childhood and new research evidence suggest a key role of cognitive, emotional and behavioral regulation in the early developmental trajectories and points to the benefits of intervention in infancy that builds on strategies of sensitive parenting. The research group behind this project has developed the PUF program (PUF: In Danish: 'Psykisk Udvikling og Funktion') to target infants' mental health and development within the settings of community health nurses. Still, measures are lacking that address the infants most vulnerable regarding the development and progression of mental health problems and overweight. In this project, we develop and test a new intensified intervention to address major cognitive and regulatory vulnerabilities identified at child age 9-10 months and adapted to the settings of community health nurses. The intervention is created as an add-on to the PUF-program, using an evidence-based method to promote sensitive parenting, the Video-based Intervention to Promote Positive Parenting (VIPP). The new intervention PUF-VIPP comprises six therapeutic sessions delivered by the community health nurse during home visits over a three months period. The intervention builds on teaching the health nurses to promote parents' sensitivity to meet the infants' cognitive and regulatory vulnerabilities, and it takes in account the needs of psycho-socially disadvantaged families. The Infant Health project is conducted in sixteen municipalities across Denmark. We use the Intervention Mapping approach as the study frame and integrate the best practice of community health nurses. The efficacy of the PUF-VIPP intervention is examined in a randomized controlled step-wedge design, in which approximately 1.000 children are followed up to the age of 24 months. The PUF-VIPP intervention is hypothesized to reduce mental health problems at ages 24 months among infants with high levels of cognitive and regulatory problems at age 9-10 months, (primary outcome). Also, it is hypothesized that among children with high levels of cognitive and regulatory vulnerabilities at age 9-10 months, adding the PUF-VIPP intervention to treatment as usual at age 9-10 months, will reduce infants' cognitive and regulatory problems; promote healthy weight development; reduce parents' experiences of stress; promote sensitive parenting and promote parents' feeling of competence and relatedness.

Start: March 2021