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Child Maltreatment clinical trials

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NCT ID: NCT05255380 Completed - Stress Clinical Trials

Examine the Effects of Mindfulness in Woman With a History of Child Adversity

EMMA
Start date: June 3, 2022
Phase: N/A
Study type: Interventional

The aim of this pilot Randomized Controlled Trial (RCT) is to test whether brief mindfulness-based practices will improve well-being and health in women (age 30-50) with a history of early life adversity. Following a baseline visit (remotely via Zoom), participants are randomized (50% probability) to either a Mindful Activity group or a Mindful Awareness group. In the Mindful Activity group, participants will complete brief (approximately 5-10 min) audio-guided mindfulness practices twice a day (morning and evening) for 8 weeks using the study app. This is followed by a brief survey about their current thoughts and feelings. In the Mindful Awareness group, participants are asked to be mindful (pay attention) to their thoughts and feelings twice a day (morning and evening) for 8 weeks using the study app. After the 8-week intervention period, all participants complete a follow-up visit (remotely). Primary goals of the pilot RCT are to test acceptability, feasibility, and adherence.

NCT ID: NCT05105373 Completed - Parenting Clinical Trials

Implementation Science and Impact Evaluation of PfR Programme: A Hybrid cRCT Design

UPRISE
Start date: August 6, 2021
Phase: N/A
Study type: Interventional

The Implementation science and impact evaluation of PfR programme: A hybrid cRCT design study will use an effectiveness-implementation hybrid type 2 design to a) determine the effectiveness and cost-effectiveness of PfR, and b) determine the feasibility and impact of three different implementation strategies in terms of programme delivery. A cluster randomised controlled trial (cRCT) will examine the effectiveness, cost-effectiveness, and implementation of the Parenting for Respectability (PfR) programme on the reduction of violence against children and gender based violence in comparison to those receiving an hour lecture on parenting in the Wakiso and Amuru districts of Uganda (N = 54 clusters, 2,160 parents, 1,080 children, 1:1 allocation ratio).

NCT ID: NCT05071924 Completed - Child Maltreatment Clinical Trials

PLH for Teens - Hybrid Delivery

Start date: July 5, 2021
Phase: N/A
Study type: Interventional

This study aims to examine the implementation and effectiveness of the original version of PLH Teens delivered in-person (PLH Teens-Original) and a hybrid in-person and remote delivery of the programme (PLH Teens-Hybrid) as part of the Mothers2Mothers' (M2M) Children and Adolescents are My Priority (CHAMP) project in Mpumalanga, South Africa. It will also examine differential effects between PLH Teens-Original and PLH Teens-Hybrid on reducing risks of violence against children using propensity score matching. Lastly, it will examine the implementation feasibility of PLH Teens-Hybrid in terms of implementation fidelity; recruitment, retention, and engagement of parents and adolescents; and the relevance, acceptability, and satisfaction of the programme.

NCT ID: NCT04809272 Completed - Child Maltreatment Clinical Trials

ePLH Pilot Study: Online Support Parent Groups - ParentChat

ePLH
Start date: March 8, 2021
Phase: N/A
Study type: Interventional

Pilot trial: The feasibility study of the programme modules has a pre-post design with no control group, with the aims of assessing programme implementation, cultural and contextual relevance, and study feasibility. Although there will be no comparison group and it is not designed to test effects, the study also has a provisional goal of reductions in child physical and emotional abuse at immediate post-intervention. Pre-post design: The ePLH parent support groups will be delivered over a 8 week period (i.e., 7-8 short online interactive group sessions, two per week). The programme will include text/audio messages, illustrated comics, videos, and activity assignments for parents to do with their children. ePLH facilitators will moderate discussions around the parenting theme, support parents on an individual basis, and encourage them to apply the parenting skills at home. Parents will be prompted to give feedback regarding successes and challenges applying these parenting skills via audio or text messages during the week. The facilitators will begin the next group engagement with a brief voice summary of the feedback and address possible solutions to 2-3 key challenges. Facilitators will also be provided with weekly supervision by an ePLH coach or trainer. A designated research assistant will provide parent support groups with needed technical support during the implementation - including IT-related support. Data bundles will be provided for internet access and to incentivise engagement.

NCT ID: NCT04606199 Completed - Stress Clinical Trials

Examine the Effects of Meditation on Daily Psychological Stress Responses in Woman With a History of Child Adversity

EMMI
Start date: November 2, 2020
Phase: N/A
Study type: Interventional

The aim of the Everyday Moments of Mindfulness (EMMI) study is to test whether brief mindfulness-based practices will improve daily psychological stress responses in women (age 30-60) who report a history of early life adversity. Following a baseline visit (remotely or in person), participants complete daily surveys and audio-guided mindfulness-based practices in everyday life via the study app. Specifically, participants receive app-notifications three times/day (morning, afternoon, evening) to complete daily surveys of current stressors and psychological states. At each notification, each participant is then randomly assigned to either receive a mindfulness-based intervention or not (max of 3 interventions/day). Thus, participants are randomized many times over the course of this 30-day study. At the end of the study, participants complete a follow-up visit (remotely or in person).

NCT ID: NCT03903445 Completed - Parenting Clinical Trials

Masayang Pamilya Feasibility Study

Start date: April 4, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to test the feasibility of (1) an 8-session version of the Masayang Pamilya (MaPa) parenting program for families with children aged 2-9 (MaPa Kids) and (2) a culturally and contextually adapted 9-session MaPa parenting program for families with children aged 10-17 (MaPa Teens). The feasibility of MaPa Kids and MaPa Teens will be assessed through self-report questionnaires, in-depth interviews and focus group discussions, and implementation data. Together, the focus groups, questionnaires, interviews, and implementation data will assess the overall feasibility of the MaPa Kids and MaPa Teen programs in the Philippines by examining program delivery, participation, acceptability, scalability, and preliminary effectiveness on reducing child maltreatment and associated risks.

NCT ID: NCT03840798 Completed - Trauma Clinical Trials

Disseminating Child Abuse Clinical Decision Support to Improve Detection, Evaluation and Reporting

Start date: March 26, 2019
Phase:
Study type: Observational

Child maltreatment is a leading cause of death and disability in children. More than 3 million reports to Child Protective Services are made every year in the US and almost 1,600 children die annually due to maltreatment. Children who are victims of maltreatment often have significant lifelong adverse health, social, and economic consequences. Accurate and timely recognition of the early signs of child maltreatment is critical to decreasing morbidity and mortality. A significant proportion of children who suffer severe morbidity and/or mortality from maltreatment had been previously evaluated by physician(s) who did not recognize the abuse. The American Academy of Pediatrics has evidence-based recommendations for the testing which should be done as part of the medical evaluation of children with suspected physical abuse. However, despite these evidence-based recommendations, physicians fail to consistently screen for and evaluate for abuse even in high-risk situations. The investigators have developed and evaluated what the investigators believe to be the first, comprehensive electronic health record (EHR) based child abuse clinical decision support (CA-CDS). This EHR-based CA-CDS system informs medical care at multiple points during the care for a potentially maltreated child, beginning with identification of suspected abuse to the handing off of information to CPS which has a mandate to protect children who are victims of suspected maltreatment. The investigators are disseminating the following aspects of the Electronic Health Record (EHR) based child abuse- clinical decision support (CA-CDS) system which they developed as part of the investigator's initial PCORI grant. 1. a universal child abuse screen (CAS) - supports identification of maltreatment 2. an embedded child abuse alert system - supports identification of maltreatment 3. alerts to physicians and advanced practice providers - supports identification of maltreatment 4. physical abuse order set - supports proper evaluation of suspected physical abuse 5. documentation assistance for making reports of suspected maltreatment to Child Protective Services - supports mandated reporting The primary objective is to disseminate and implement CA-CDS in two different EHRs in two hospital systems - Northwell Health (NY) and University of Wisconsin (WI) - and to assess whether the CA-CDS improves identification, evaluation and mandated reporting of child maltreatment. Aim #1 is to compare the rates of identification of possible child abuse - defined as reports to Child Protective Services - before and after integration of CA-CDS into the EHR among children presenting to 5 Emergency Departments in two different health systems. Aim #2 is to compare the rate of physician compliance with American Academy of Pediatrics guidelines for evaluation of suspected physical abuse before and after integration of CA-CDS into the EHR in 5 Emergency Departments in two health care systems. Once the D&I is complete, the investigators will have demonstrated the feasibility of implementing the CA-CDS in the three EHRs which make up 85% of all the US EHRs. This is a critical step towards the goal of having a CA-CDS as a standard EHR component.

NCT ID: NCT03329625 Completed - Child Maltreatment Clinical Trials

Preventing Conduct Disorder in Child Welfare

Start date: July 5, 2010
Phase: N/A
Study type: Interventional

A mixed methods randomized control trial was conducted to test the effectiveness of Pathways Triple P with child welfare involved families compared to treatment as usual. Outcomes tested included parenting behaviors and attitudes, and child behavior problems. 144 families were recruited into the study. Data was collected at 4 time points (baseline, 4 months, 9 months, and 18 months). Over 70% were retained from baseline to 18 months.

NCT ID: NCT03205449 Completed - Child Maltreatment Clinical Trials

Parenting for Lifelong Health (PLH) - Masayang Pamilya (MaPa) Evaluation Study

PLH-MaPa
Start date: June 16, 2017
Phase: N/A
Study type: Interventional

Parenting for Lifelong Health (PLH) Philippines Evaluation Study: Multisite randomised controlled trial to compare the efficacy of a culturally-adapted parenting programme, Masayang Pamilya, versus services as usual in the reduction of child maltreatment and improvement of child wellbeing in low-income Filipino families with children aged two to six years in Metro Manila (N = 120). A previous study focused on adaptation and feasibility testing was conducted from January 2016 to February 2017. Community-based participatory approaches were used to culturally adapt the Sinovuyo programme to a Filipino context. A formative evaluation using qualitative in-depth interviews and focus group discussions with parents, as well as consultative workshops with service providers and other stakeholders, examined issues regarding the needs and concerns of Filipino parents, appropriateness of intervention components and delivery, and other specific cultural issues in order to balance "fidelity" to evidence-based practices with "fit" to the local context [11]. The Sinovuyo programme was then adapted into the MaPa programme with local materials and approaches developed to fit the Philippine cultural context based on findings from the formative evaluation.

NCT ID: NCT02979262 Completed - Clinical trials for Intimate Partner Violence

Intimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment

Start date: May 2016
Phase: N/A
Study type: Interventional

The proposed stage 1 intervention development study is designed to address two significant co-occurring issues for fathers with substance abuse (SA) problems: Intimate partner violence (IPV) and child maltreatment (CM). SA treatment programs are an important avenue to reduce family violence because SA treatment alone does not result in an end to these behaviors. Currently available interventions have had little success in reducing male IPV. Fathers for Change, an integrated outpatient intervention, shows promise as an intervention model targeting the intersection of SA, IPV, and CM. The intervention uses men's roles as fathers as a motivation for change and targets factors that are known to trigger SA, IPV and CM: hostile cognitions and poor emotion regulation. An intervention of this sort has not been integrated and tested as part of a residential substance abuse program for men. This project is a pilot study of 60 fathers randomly assigned to Fathers for Change or a Parent Education Program (PE) comparison. The initial feasibility of the Fathers for Change will be assessed by comparing it to PE in the areas of: participant completion rates, hostile cognitions, emotion regulation, SA relapse, IPV, and CM risk behaviors (negative parenting). Change in hostile cognitions and emotion regulation will be examined as the mechanisms through which Fathers for Change reduces relapse, IPV and CM risk behaviors.