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Parent-Child Relations clinical trials

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NCT ID: NCT05332236 Completed - Clinical trials for Parent-Child Relations

Parent-adolescent Communication: Validation of a German Language Scale and Its Association With Child Mental Health

Start date: May 20, 2022
Phase:
Study type: Observational

A German version of the Parent-Adolescent Communication Scale (PACS, Barnes & Olson, 1982) will be validated in a large sample of children (10-18 years) and their parents. As a secondary objective, the association of communication quality, children's somatic symptoms and mental health will be explored.

NCT ID: NCT05262920 Completed - Pain, Acute Clinical Trials

Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study

PROMPT
Start date: March 16, 2022
Phase: N/A
Study type: Interventional

Every year, 1 million women cease breastfeeding (BF) before 6 months, the minimum time required for optimal maternal well-being and infant's health, physical growth, and development. The highest rate of BF cessation occurs within 3 weeks after birth, with 30% of women ceasing BF due to acute breast and nipple pain (BNP). BNP is a complex and understudied biobehavioral phenomenon involving nociceptive signalling that stimulates multiple pain pathways. Women who experience BNP beyond BF initiation report lower BF self-efficacy a key predictor of BF at 6 months, increased maternal distress symptoms, and may differ across races contributing to differences in early BF cessation rates. The investigators developed and tested a 6-week nurse-led and participant-informed, Breastfeeding and Breast and Nipple Pain Self-Management (BSM) intervention guided by the Individual and Family Self-Management Theory. Aligned with the needs and preferences elicited from a diverse sample of BF participants, the investigators used a cloud-based platform, to deliver BF knowledge and skills, and provided support through nurse-led text-based communication to decrease BNP, increase BF self-efficacy, decrease burdensome face-to-face visits, and increase adaptive coping behaviors. Participants in the BSM intervention group reported significantly reduced BNP intensity at 1 and 2 weeks which predicted increased BF self-efficacy and decreased anxiety at 6 weeks. Based on these promising results, the investigators propose to examine the efficacy of the BSM intervention in an R56 RCT, Promoting Self-Management of Breast and Nipple Pain Using Technology (PROMPT) for Breastfeeding Women to decrease BNP intensity and interference and increase BF exclusivity. The study will reproduce and extend the pilot findings by exploring in a diverse population of BF participants, how participants' pain sensitivity affects BNP. The study will explore the moderating role of BNP, and maternal well-being symptoms of fatigue, depressive symptoms, anxiety, and sleep, pain, pain coping, and maternal self-efficacy, on BF exclusivity. Participants (N = 222) intending to breastfeed will be randomized to the BSM intervention or the attention control group with assessments performed at baseline, 1, 2, 3, 6, 9, 12, 18, and 24 weeks. Study results will advance knowledge on the BSM intervention, with direct implications for nurse-designed and led self-management interventions in clinical settings or health care systems.

NCT ID: NCT05117099 Completed - Depression Clinical Trials

Middle School Success Over Stress

MSSOS
Start date: October 11, 2021
Phase: N/A
Study type: Interventional

It is clear that the COVID-19 pandemic has impacted families adversely in multiple ways, including economic stressors, mental health-related functioning, social/familial functioning, as well as responses to mandated safety measures (e.g. social distancing, stay-at-home orders, mask-wearing). Furthermore, families of school-age children have had to navigate online instruction and home schooling in the context of these difficult circumstances with little preparation for doing so effectively. School districts have varied widely in their ability to support parents during this crisis. These stressors are likely to have disproportionately adverse effects on lower-income and racial/ ethnic minority populations, for whom economic, academic, and family-level challenges were already pronounced. For instance, health effects of COVID-19 have hit African American and Latinx populations with disproportionate severity, including higher rates of hospitalization and death. Given the scale of pandemic impacts for families with school-aged children, the identification of effective family-focused interventions that target core mechanisms of change with a broad range of benefits for parents and youth across diverse populations, and that can be brought to scale rapidly and with fidelity, represent critical public health goals. In this research study the investigators will adapt and test the efficacy of the Family Check-Up Online as a treatment to foster resilient family functioning in response to the COVID-19 pandemic. The investigators will test the effects of the adapted FCU Online program on key mechanisms of change that are predicted to directly impact child and family functioning: parenting skills, parental depression, and parent and child self-regulation. The investigators predict that changes in these key targets of the intervention will impact participant's response to the COVID-19 pandemic, including youth depression and behavior problems, the ability to cope with pandemic-focused stressors, and social/familial functioning.

NCT ID: NCT05019339 Completed - Parenting Clinical Trials

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

Start date: November 19, 2021
Phase: N/A
Study type: Interventional

Childhood obesity prevention efforts are needed in the United States, especially for families with low income. Educating parents and caregivers on simple lifestyle and affordable home environment changes is an effective strategy to improve health outcomes for the entire family. Therefore, the purpose of this study is to determine whether HomeStyles-2, a nutrition education and childhood obesity prevention program for families with children in middle childhood (ages 6 to 11 years), motivates parents to shape their home environments and weight-related lifestyle practices to be more supportive of optimal health and weight status of their children aged 6-11 years more so than those in the control condition. The study will include the experimental group and an attention control group who will engage in a nutrition education program, Eat Healthy Be Active, that is equal in nonspecific treatment effects but does not overlap on topics covered in HomeStyles-2. This study will be implemented in Florida's Supplemental Nutrition Assistance Program-Education (SNAP-Ed) program, which provides nutrition education and obesity prevention supports for individuals with low income who are receiving or eligible for SNAP benefits. Nutrition Educators will be randomized to the experimental or attention control condition, and will lead participants through virtual, group-based nutrition education series. The following data will be collected: sociodemographic characteristics of the participant and child; child and parent health status; parent weight-related cognitions; weight-related behaviors of the participant and child; and weight-related characteristics of the home environment. Enrollment for this study will begin late-2021.

NCT ID: NCT04989738 Completed - Sleep Clinical Trials

Teaching Healthy Responsive Parenting During Infancy to Promote Vital Growth and dEvelopment (THRIVE) Study

THRIVE
Start date: August 5, 2020
Phase: N/A
Study type: Interventional

Background. Unprecedented rates of overweight and obesity are seen in childhood1 with evidence suggesting that infancy may be a critical period for the development of this high weight trajectory. This has led to a call for proposals for "understanding factors in infancy and early childhood (birth to 24 months) that influence obesity development (PA-18-032)." Objectives. The current study seeks to recruit a sample of mother-infant dyads to pilot a responsive parenting focused obesity prevention program delivered by behavior and development specialists in pediatric primary care. Methods. Approximately 80 mother-infant dyads will be recruited in pediatric primary care at their newborn visit and randomly assigned to one of two groups: a) Healthy Growth (new intervention) or b) Healthy Steps (as usual). We will obtain assessments of growth, feeding, and sleep throughout the study period for infants across five clinic visits and at-home measure completion. Research clinic visits will take place at their regularly scheduled well-child check visits at ages 1, 2, 4, and 6 mos and in-home measures will be completed monthly. The intervention program is hypothesized to show efficacy in both breast and formula fed infants as measured by the primary (i.e., BMI percentile and BMI z-score) and secondary outcomes (e.g., awareness of infant cues, use of alternative soothing strategies, when it is not time for a feeding).

NCT ID: NCT04938063 Completed - Cerebral Palsy Clinical Trials

Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy

Start date: January 1, 2021
Phase:
Study type: Observational

1. To find out the relation between the severity of ADL limitation in diplegic CP children and the level of parents' stress. 2. To detect the correlation between the PS level to the different domains of ADL limitation. 3. To determine the substantial factors that underlying the parents' stress of those diplegic CP children.

NCT ID: NCT04904861 Completed - Parenting Clinical Trials

Group Videoconferencing Intervention to Improve Maternal Sensitivity

Start date: July 30, 2021
Phase: N/A
Study type: Interventional

Background: Early childhood development is highly dependent on the sensitive care provided by their caregivers . Interventions focused on supporting parents to improve their sensitivity have been shown to be effective . The COVID-19 pandemic has had a great impact on mental health , with pregnant women and mothers of children under one year of age being an especially vulnerable group . On the other hand, access to mental health interventions in person is restricted by confinement measures , especially group interventions, so it is relevant to have remote interventions that support this group of mothers. Objectives: to evaluate the feasibility and acceptability of a group videoconferencing intervention to improve maternal sensitivity aimed at mother / infant dyads attended in Primary Health Care in Chile Methodology: a randomized pilot feasibility study will be carried out with a mixed design with quantitative and qualitative evaluations. A face-to-face group intervention with proven effectiveness will be adapted to videoconferencing format , then 50 dyads will be randomized in a 3: 2 ratio to receive the videoconferencing intervention ( n=30) or the delivery of educational brochures (n=20) . The feasibility and acceptability will be evaluated assessing the participation, adherence and satisfaction in a quantitative way, in addition the qualitative evaluation will be carried out through interviews and focus groups. Changes in clinical outcomes will also be evaluated: maternal sensitivity, depressive symptoms, postnatal maternal attachment and infant socio-emotional development. This pilot study will allow the identification of the key parameters for the implementation and evaluation of the intervention, which will allow the design of an effectiveness study in the future.

NCT ID: NCT04871659 Completed - Parenting Clinical Trials

Attitudes Behavior and Practices of Mothering Among an Online Panel

Start date: March 15, 2021
Phase:
Study type: Observational

Subjects are users on Amazon's Mechanical Turk (MTurk) platform. MTurk users will be asked to complete a screening survey about family structure. The purpose of the screening survey is to identify MTurk users who are biological mothers of children aged 1.5 to 6 years old, and to collect survey information on how mothers interact with their children, with the aim of better understanding family relationships.

NCT ID: NCT04748731 Completed - Depressive Symptoms Clinical Trials

Video Feedback to Improve Parental Sensitivity in Mother-infant Dyads With Depressive Symptoms

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Title: "Internet mentalization-based video feedback intervention to improve parental sensitivity in mother-infant dyads with maternal depressive symptoms: randomized controlled feasibility trial". Funding: ANID Millennium Science Initiative /Millennium Institute for Research on Depression and Personality-MIDAP ICS13_005 (MIDAP, www.midap.org). Principal Investigator: Marcia Olhaberry Huber, PhD, Academic, School of Psychology, Pontificia Universidad Católica de Chile, Associate Researcher, MIDAP. MIDAP Research Team: Javier Moran, PhD. Academic at the University of Valparaíso, María José León, PhD, Stefanella Costa, PhD. and Fanny Leyton, PhD. (c) University of Valparaíso. General Objective: To evaluate feasibility and acceptability of a brief Internet mentalization-based video feedback intervention to improve sensitivity in mothers with depressive symptoms. Key parameters for a future effectiveness study will be identified Design: Pilot randomized clinical trial; Participants: 60 mother-infant dyads (aged 4-12 months) attended in Public Health Centres.30 dyads will be assigned to the experimental group (EG) and will receive a weekly online brief intervention using video-feedback and psycho-educational materials on early parenting. 30 dyads will be assigned to the control group (CG) and will receive only psycho-educational materials. The study includes 3 assessments (pre-intervention, post-intervention and follow-up) and four weekly intervention sessions. Data analysis: For quantitative data descriptive statistics and ANCOVA will be used, for qualitative data Grounded Theory.

NCT ID: NCT04706442 Completed - Anxiety Clinical Trials

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

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

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 frequently asked questions (FAQ) expert advice section. The aims of the study are to: 1. develop theory-based supportive parenting App (SPA) intervention for both first-time and experienced parents across perinatal period 2. 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) 3. evaluate SPA's cost-effectiveness as compared to standard perinatal care across major restructured hospitals, and 4. examine the perceptions of parents in receiving this intervention. When compared with those in the control group receiving standard care: 1. parents receiving SPA intervention will have better- emotional well-being (reduced depression and anxiety);parenting self-efficacy; social support; bonding and satisfaction. 2. new-borns of parents receiving SPA will have better physical, social and emotional development 3. It will be more cost-effective to provide SPA than the standard care