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NCT05367102
The overarching objective for the Supporting Health Relationships (SHR) program is to create and sustain families in the Bronx by improving relationship skills, improving parenting skills, and improving parental financial support for children. The investigator's local evaluation addresses a research question about the effectiveness of delivering the SHR curriculum virtually: To what extent do couples show improvements in engagement, skills learning, and relationship quality outcomes when receiving the curriculum over Zoom?
NCT03910491
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.
NCT06865183
The goal of this clinical trial is to determine whether a brief positive parenting seminar series delivered virtually helps teach parents additional tools and strategies to support healthy child development, encourage good behavior, and manage misbehavior, while improving parenting practices and child outcomes for parents of children ages 2-12. The main questions it aims to answer are whether parents are satisfied with the intervention and find the strategies helpful and acceptable, whether the intervention leads to changes in parenting behaviors (e.g., positive parenting) and child outcomes (e.g., emotional and behavioral problems), and how removing the active discussion from the seminars impacts parents' ability to improve their parenting skills and their child's outcomes. Researchers will compare three groups: parents receiving the seminars with a group discussion, parents receiving the seminars without a group discussion, and parents on a waitlist. This will help determine if group discussions lead to greater improvements in parenting practices and child outcomes. Participants attended three online parenting seminars via telehealth (if assigned to a seminar group). They completed surveys before, during, and after the seminars to share their experiences and provide feedback. Participants in the waitlist group completed surveys at the beginning and end of the study, and will participate in the seminars after the study period.
NCT02973906
The overarching goal of this study is to advance research on family-based prevention of negative child outcomes for reintegrating Operation Enduring Freedom/Operation Iraqi Freedom personnel by evaluating different formats of a parenting program, After Deployment, Adaptive Parenting Tools (ADAPT). The ADAPT program is based upon the Parent Management Training-Oregon Model/PMTO, but adapted for military deployed families. The PI will examine which of three delivery formats of ADAPT is most effective at reducing youth risk behaviors associated with negative childhood outcomes by improving parenting, child, and parent adjustment. There is a clear intent to benefit all subjects in this study (except surveyed teachers), including children.
NCT06170047
The primary objective of this study is to test the effects of an evidence-based prevention intervention (CPP) adapted for foster and kinship caregivers of young children (FC; foster care) on caregiver competence and child behavior problems for children in foster care compared with an active comparator group that receives standard supports through the child welfare and healthcare systems (i.e., usual care).
NCT06492278
This is a randomized open pilot trial enrolling up to 40 co-primary caregivers of children with LAD. Participants will be randomized to receive either mind-body resiliency group (SMART-LAD, intervention) or an evidence-based group intervention Health Education Program (HEP, control) which is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team. Both the SMART-3RP and HEP programs have been modified based on adaptions from our previous qualitative study.
NCT07461038
Problem: While partner support benefits breastfeeding outcomes, its impact across perinatal stages on maternal co-parenting perception is unclear. Background: Spousal involvement plays a vital role in successful breastfeeding and maternal well-being. Aim: This study aimed to examine the effects of spousal participation in breastfeeding interventions at different perinatal stages on maternal co-parenting perceptions and infant feeding practices for full-term infants. Methods: Pregnant women who received antenatal care and delivered at our hospital, together with their partners, were recruited and categorized by the timing of partner involvement in breastfeeding activities: both antenatal and postnatal (Group A); antenatal only (Group B); postnatal only (Group C); and no antenatal education but routine postnatal guidance (Group D). Maternal breastfeeding self-efficacy and coparenting perception were assessed at 6, 12, and 24 weeks postpartum.
NCT07447921
The goal of this clinical trial is to learn whether improving caregivers' mental health and parenting practices can enhance child wellbeing among Congolese refugee families living in the Nyarugusu Refugee Camp, Tanzania. The WEMA trial ("Wellbeing through combined Evidence-based tools for Mental health and Attuned parenting") is a three-arm, family-level cluster-randomized, controlled superiority trial involving 324 families (approximately 648 children aged 7-10 years and their two primary caregivers). Participants and intervention facilitators will know which program a family receives, but outcome assessors (enumerators) will not know group assignment. The main questions it aims to answer are: * Does Self-Help Plus (SH+), a World Health Organization (WHO) group stress-management program, improve children's emotional and behavioral functioning at 12 months post-intervention, compared with usual care? * Does adding Interaction Competencies with Children for Parents (ICC-P), a participatory parenting program, after SH+ further improve children's emotional and behavioral functioning at 12 months post-intervention, compared with SH+ alone? Researchers will compare (1) Usual Care, (2) SH+, and (3) SH+ followed by ICC-P to see whether SH+ improves outcomes versus usual care, and whether SH+ followed by ICC-P provides additional benefits beyond SH+ alone. Participants will: * Be assigned by chance by family clusters to one of three groups: Usual Care, SH+, or SH+ followed by ICC-P. * Receive either (a) information about available psychosocial and mental health services (Usual Care), (b) SH+ (five group sessions delivered by trained non-specialists), or (c) SH+ followed by ICC-P (a four-day participatory parenting training to strengthen positive parenting and reduce harsh discipline). * Complete study assessments at baseline, 3 months, and 12 months post-intervention. The primary outcome is children's emotional and behavioral functioning, measured using the Pediatric Symptom Checklist-17 (PSC-17) at 12 months post-intervention. Secondary outcomes include children's wellbeing and quality of life, as well as caregivers' mental health, well-being, and parenting practices. Additional exploratory outcomes will also be assessed, including measures collected from caregivers and behavioral tasks with children. The trial is implemented by Uppsala University in collaboration with the Dar es Salaam University College of Education (DUCE) and partners, with funding from the Swedish Research Council (grant no. 2022-02476).
NCT04244318
This is a study protocol of a randomized controlled trial, which aims to validate the effectiveness of the ODISEA Trauma intervention (parental thearpy + videofeedback) compared to a control group. The data collection will be through a three point evaluation (pre, medium and post intervention) using the parenting skills questionnaire (E2P short form), parental stress index - short form (PSI-SF), the adult emotional regulation questionnaire (ERQ), an adult reflective function questionnaire, the parental reflective function questionnaire (PRFQ), the child abuse potential inventory (CAPI), and the socioemotional competence scale for children (ECOS). Additionally, caregivers will be screened for ACES and with a sociodemographic characterization questionnaire. At the same time, profesionals will be assessing caregivers using an scale to measure complex trauma in adults (ECTA). The primary outcome aims to measure the effectiveness of the intervention within the parenting domain (positive parenting practices) and parental trauma (complex trauma, adult emotion regulation, reflective function and child abuse potential of the caregivers). The secondary outcomes will be to assess parenting stress, socioemotional competencies of children and implementation fidelity compared to accumulated risk.
NCT07376369
The transition to motherhood, particularly for first-time (primiparous) women, is a critical life period requiring substantial psychological and social adjustment. Hormonal changes, increased caregiving responsibilities, sleep disturbances, and potential social isolation during pregnancy and the postpartum period may increase vulnerability to stress, anxiety, and depressive symptoms. Postpartum depression (PPD) is a common mental health concern that adversely affects maternal well-being, mother-infant interaction, and infant development, with insufficient social support identified as one of its most significant risk factors. Maternal self-efficacy, defined as a mother's perceived competence in caring for and responding to her infant's needs, is a key indicator of successful adaptation to the parenting role. Evidence suggests that maternal self-efficacy develops primarily within the first months after childbirth and tends to be lower in primiparous women. Low parenting self-efficacy has been associated with increased depressive symptoms, higher parenting stress, impaired mother-infant bonding, and negative developmental outcomes for the infant. Among social support sources, partner support plays a particularly protective role during the transition to parenthood. Emotional, informational, and practical support provided by the partner has been shown to enhance maternal self-efficacy, reduce psychological distress, improve marital adjustment, and lower the risk of postpartum depression. Conversely, low perceived partner support and relationship difficulties are associated with an increased risk of PPD in primiparous mothers. The aim of this study is to examine the relationship between perceived partner support and postpartum parenting self-efficacy and depressive symptoms in primiparous women. Additionally, the study seeks to evaluate the explanatory and protective role of partner support on maternal self-efficacy and postpartum depression during the early postpartum period.
NCT06569303
The goal of this clinical trial is to test the effectiveness of an online parenting program on Filipino parents living in California. The main aims are to: * Test the effectiveness of the online Incredible Years® model of parent training and its impact on primary outcomes. * Determine the impact of intervention engagement (i.e., higher attendance) on parenting practices and child behavior outcomes. * Describe Intervention delivery and its online implementation in real-world community settings. The study involves two phases: * Phase 1: Participants will receive the Online Incredible Years® School Age Basic \& Advanced Parent Training Program (intervention) and complete parent-reported and child-reported measures at baseline, 3 months and 6 months. * Phase 2: Parenting Group Leaders will each participate in one semi-structured interview to inform the sustainability of the intervention in real world community settings. Researchers will compare 250 Filipino families, half of which will receive the intervention and the other half will receive the American Academy of Pediatrics' Bright Futures handouts (control) and be placed on a 3-month waitlist for the IY parenting program. Both groups will be followed for a minimum of 6 months with follow- up assessments that include parent-report and child report measures.
NCT07341815
This prospective, two-arm randomized trial compares a psycho-educational program to a psycho-educational and experiential program for parents with advanced cancer. These two interventions aim to support parent-child communication about cancer, but we hypothesize that the combined intervention will be more effective for all studied communication variables.
NCT05729945
This study involves a long-term outcome study of the Catholic Health Initiative St. Joseph's Children (CHI SJC) program using a randomized control study. The purpose of this study is to determine the short-term and long-term impact and effectiveness of the CHI SJC program. The CHI SJC program has not been studied to determine program effectiveness. The investigators intend to follow families and their children until the children in the study graduate from high-school or turn 19 years of age. The study, as a template, uses the eight outcome domains listed and described in the Home Visiting Evidence of Effectiveness website (http://homvee.acf.hhs.gov/outcomes.aspx). These eight domains are: * Child development and school readiness * Family economic self-sufficiency * Maternal health * Reductions in child maltreatment * Child health * Linkages and referrals * Positive parenting practices * Reductions in juvenile delinquency, family violence, and crime The investigators expect to observe significant differences among the two groups with respect to the primary outcome domains listed. The investigators expect study group members randomized to the CHI SJC program will perform better on the eight outcome domains. Other hypotheses include: Other Hypotheses: Hypothesis 1. Randomization to CHI SJC will be associated with higher quality functioning and better child health and well-being. Hypothesis 2. Randomization to CHI SJC will result in more connections to community resources. Hypothesis 3. Randomization to CHI SJC will result in improved indications of maternal health and positive parenting practices. Hypothesis 4. Randomization to CHI SJC will be associated with higher measures of family economic self-sufficiency. Hypothesis 5. Randomization to CHI SJC will be associated with increased school readiness and school progress and attainment. Hypothesis 6. Randomization to CHI SJC will be associated with reductions in juvenile delinquency, family violence, and crime. The study will collect outcome data in the same way and, at the same time, from treatment and control group members. Data collection will primarily be comprised of a set of self-report questionnaires and a review of administrative records that target the outcome domains described earlier. Study group members will be assessed at baseline, 6 months, 12 months, 18 months, 24 months, 3 years, 5 years, 8 years, 12 years, 15 years, and at high-school graduation or 19 years of age.
NCT07318168
This randomized pilot trial tests a brief psycho-educational group program designed to enhance maternal reflective functioning (RF)-the capacity to understand one's own and the baby's behavior in terms of thoughts and feelings-among first-time mothers in the early postpartum. Primiparous women aged ≥18 years, 1-5 months postpartum, were randomized 1:1 to the intervention or a wait-list control. The intervention consists of four weekly 90-minute Zoom sessions with short home practices. The primary outcome is interview-based RF assessed with the FMSS-RF (blind-coded) at post-intervention. Exploratory outcomes include self-reported RF (PRFQ-CMS), depressive symptoms (EPDS), emotion-regulation (ERQ-Suppression), and feasibility/acceptability indices (recruitment, retention, attendance, satisfaction). This single-site study is conducted at the University of Haifa (Faculty of Education). If effective, the low-intensity, telehealth format may offer a scalable postpartum support option for first-time mothers.
NCT05598970
Digital solutions can significantly improve the delivery of Early Childhood Development (ECD) services in Low- and Middle-Income Countries (LMICs). Traditional home-visits and community group-based parenting approaches require intense levels of training, mentoring and supervision of Community Health Workers (CHWs) that is difficult to sustain when transitioning to scale. Context relevant digital tools can support CHWs in delivering high-quality, respectful, and standardised multi-sectoral household ECD services by tailoring services to pregnant women and engaging male caregivers. This could have significant impacts on child development, including stimulation, speech and language development, nutrition, and cognition. Moreover, cash delivered through digital modes of payment is faster, safer, easier to administer, is scalable and has potential to empower women, influence parental investment and affect household decision making. The study will conduct a clustered multi-arm Randomised Controlled Trial (cRCT) targeting pregnant mothers across all 7 districts (and all 8 district councils) in the Dodoma region in Tanzania. Following the study sample for 15 months from 5-7 months pregnancy. The study will test and compare the causal effects of (i) a digitally supported Parenting Intervention delivered by CHWs, which aims to improve caregivers' access to quality ECD services; (ii) a mobile unconditional cash transfer which aims to relax financial resource constraints; and (iii) a digitally supported Parenting Intervention when combined with a mobile unconditional cash transfer. Findings from the study are expected to have important policy implications for the design of scalable ECD interventions targeting pregnant mothers in Tanzania and other LMIC settings.
NCT06163703
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.
NCT03058861
The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting intervention in pediatric primary care.
NCT05444205
The Early Childhood Collaborative of The Pittsburgh Study is a community-partnered, county-wide implementation of programs for children and families from birth through formal school entry to address real-world challenges that exist in providing effective preventive interventions for families with young children, particularly low-income families.
NCT03880383
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: 1. 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. 2. 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.
NCT06626750
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.