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Psychosocial Problem clinical trials

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NCT ID: NCT04238949 Active, not recruiting - Diabetes Mellitus Clinical Trials

Community Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes

Start date: December 6, 2019
Phase: N/A
Study type: Interventional

The primary aim of this pilot randomized controlled trial is to determine if the integration of a Community Health Worker (CHW) into the healthcare team of children with newly diagnosed type 1 diabetes is associated with an improvement in diabetes control. The secondary objectives are to determine if utilization of CHWs is also associated with improvements in psychosocial outcomes, healthcare utilization, and decreased costs.

NCT ID: NCT04234815 Completed - Clinical trials for Psychological Distress

Evaluating Impacts of CSS for Veterans and Their Families in Ukraine

Start date: February 28, 2020
Phase: N/A
Study type: Interventional

This cluster-randomized controlled trial (c-RCT) evaluates the effectiveness of a brief, single-session psychosocial workshop, "CETA Short Session" (CSS), for reducing symptoms of distress and functional impairment and increasing treatment engagement among conflict veterans and their families in Ukraine. The CSS workshop includes psychoeducation, review of a self-assessment, safety screening, and training in cognitive coping. This will be evaluated against a single-session comparison workshop that includes all of the same workshop elements except for cognitive coping. Registration for both conditions includes completion of a self-assessment. Participants with safety concerns or very severe symptoms will be immediately referred to mental health treatment; others will be asked to wait for one month before being reassessed and, if indicated, referred to mental health treatment. Both conditions include an individual check-in phone call one week after the workshop. Distress and functional impairment outcomes will be assessed one month from baseline. Treatment engagement outcomes will be assessed three months from referral. The investigators hypothesize that individuals attending sessions randomized to CSS will show greater improvement in mental health outcomes and greater treatment engagement than those attending sessions randomized to the comparison condition. With the onset of the COVID-19 pandemic in Spring 2019, the RCT was paused to develop and pilot an online version of both the CSS and comparison workshop. The trial protocol has now been expanded to continue the effectiveness trial while allowing for both online and [when/if feasible] in-person intervention delivery.

NCT ID: NCT04039386 Not yet recruiting - Hip Osteoarthritis Clinical Trials

Psychosocial Interventions for Young Adults With Hip Pain

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Psychosocial conditions are common in young adults with hip pain including depression, anxiety, pain catastrophizing, and narcotic use. The incidence of these conditions is not well defined. Interventions to optimize psychosocial conditions with non-surgical or surgical treatments has not been investigated. The goal of this project is to determine the incidence of psychosocial conditions in the young adult population with hip pain and determine if cognitive based therapy can improve clinical outcomes in these individuals.

NCT ID: NCT03542500 Completed - Clinical trials for Mental Health Disorder

Youth FORWARD Phase 2 YRI and EPP Study

Start date: July 19, 2019
Phase: N/A
Study type: Interventional

Objectives: The objectives of this research proposal are to study the delivery of an evidence-based mental health intervention in the alternate setting of youth employment programs tied to regional economic development and to examine the use of a Collaborative Team Approach (CTA) as an implementation scale-up strategy that addresses the human resource shortage and related access to care and capacity challenges in low- and middle-income countries (LMICs). Specifically, this study aims to examine the incorporation of the evidence-based Youth Readiness Intervention (YRI) into a program that promotes employment among youth (EPP/Entrepreneurship Training program) through a pilot study and scale-up intervention study in Sierra Leone. Study population: The study population includes youth, ages 18-30, with elevated t-scores on assessments of functional impairment and emotional dysregulation, who live in the Kono, Koinadugu and Kailhun districts of Sierra Leone. Scale-up study design: For the scale-up study, a Hybrid Type 2 Effectiveness-Implementation Cluster Randomized Three-arm trial will be employed. We estimate the entire sample size for the scale-up study to be 3,630 participants, including 1200 youth, 10 agency heads, 20 intervention facilitators, and 2400 third-party informants. Upon enrollment into the study, youth will be assigned to community level sites based on geographical location. Each of these community level sites will make up one cluster. These clusters will be randomized into the three study conditions: the control condition - where youth do not receive the YRI or the EPP but are able to utilize as available resources in the community - the EPP-only condition, and the YRI+EPP condition. Data will be collected at baseline, post-YRI, post-EPP, and 12-months follow-up. Scale-up study outcomes: Implementation outcomes of the Hybrid Type II study are focused on process and implementation aspects including a costing analysis, measures of fidelity and the sustainment and quality of delivering YRI within a Collaborative Team Approach to support intervention delivery, training and supervision. Effectiveness outcomes of the Hybrid Type II study are development of emotion regulation, mental health assessed as anxiety and depression, and interpersonal functioning, including self report and by third-party reporters for assessment of the YRI's ability to improve youth's interpersonal skills and functioning in the community and the entrepreneurship training program. In a Hybrid Type II study implementation and effectiveness aims are dual and equally important aspects of the study. (Curran et al., 2015) Outcomes associated with both aims are considered primary outcomes in this study.

NCT ID: NCT03475108 Active, not recruiting - Diabetes Mellitus Clinical Trials

Integrating Community Health Workers Into the Care of Children With Type 1 Diabetes

Start date: April 19, 2018
Phase: N/A
Study type: Interventional

The primary aim of this randomized controlled trial is to determine if the integration of a Community Health Worker into the healthcare team is associated with an improvement in diabetes control in children with type 1 diabetes. The secondary objectives are to determine if utilization of Community Health Workers is also associated with reduced emergency department visits and hospitalizations, improved attendance at outpatient diabetes appointments, and improvements in psychosocial outcomes and diabetes control.

NCT ID: NCT02672670 Recruiting - Spinal Cord Injury Clinical Trials

Effects of a Coping-oriented Supportive Programme (COSP) for People With Spinal Cord Injury During Inpatient Rehabilitation

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

The aim of this proposed PhD study is to test the effectiveness of a newly developed coping-oriented supportive programme (COSP) for Chinese people with SCI during their early period of inpatient rehabilitation in Xi'an, China. The objectives of this study are to develop and validate the COSP in the inpatient rehabilitation hospitals; and to evaluate the effectiveness of this COSP for the SCI inpatients in two rehabilitation wards on their coping abilities, self-efficacy, mood status, and life satisfaction, when compared to those receiving routine care in another two rehabilitation wards. This proposed PhD study is a quasi-experimental study, using repeated-measures, comparison group design. The study will be conducted in two rehabilitation hospitals in Xi'an, China. There will be 50 patients in each of the two study groups (i.e., one intervention and one comparison group). The intervention group will receive the COSP including 8 weekly sessions, and the comparison group will receive usual rehabilitation care in brief didactic group-based education. Outcome measures will be examined at baseline and immediately, 1- and 3-month after completion of the interventions. The primary outcomes of this proposed study are coping ability and self-efficacy, while the secondary outcomes include mood status, life satisfaction, and pain. All data will be analysed using SPSS for Windows, version 21.0. Descriptive statistics will be employed for demographic and disease-related data and outcome scores. Data analysis for intervention effects will be based on both Per-protocol (PP) analyses and Intention-To-Treat (ITT). The missing data will be handled by the Last Observation Carried Forward (LOCF) strategy. Inferential statistics will be conducted for between-group and within-group comparison with specific considerations with the measurement level of the data and the fulfillment of the statistical assumptions of parametric or non-parametric tests, and further consider to use multivariate analysis of covariance (MANCOVA) or the analysis of covariance (ANCOVA).This study will provide evidence on the clinical effectiveness of the coping-oriented supportive programme in improving patients' psychological adjustment to SCI during earlier stage of inpatient rehabilitation, enhancing their psychosocial adaptation to the illness and subsequent life satisfaction and hence, integrating this psychosocial intervention into the conventional treatment and SCI rehabilitation practices.

NCT ID: NCT01946958 Completed - Parenting Clinical Trials

Triple P With Pediatric Residents

Start date: July 2011
Phase: N/A
Study type: Interventional

The objective of this study is to conduct a randomized control trial to evaluate the impact of Triple P on the clinic practice of pediatric residents and on select parent and child outcomes. This study will accomplish that overarching goal through addressing two specific aims. Aim 1. Triple P's Effect on Pediatric Resident's Practice: test the effect of Triple P training on practice of pediatric residents in addressing and managing psychosocial problems. Hypothesis 1: At the completion of the trial, residents assigned to the intervention group, compared to residents exposed to the control condition, will have: 1. increased skill levels, 2. increased confidence, and 3. increased satisfaction in dealing with and managing psychosocial issues Aim 2. Triple P's Effect on Parent and Child Outcomes: test the effect of Triple P interventions on parent's feelings of self efficacy, parent's discipline strategies and on children's externalizing behavior. Hypothesis 2: At the completion of the intervention, parents and children receiving the intervention, compared to those receiving the control condition, will have: 1. greater reduction in targeted child behavior problems, 2. greater reduction in dysfunctional parenting practices, 3. increased use of appropriate discipline and positive parenting strategies, and 4. greater confidence in parenting ability.

NCT ID: NCT01804855 Active, not recruiting - Obesity Clinical Trials

Effectiveness of a Smartphone App for Adolescent Obesity Management

Start date: February 2013
Phase: N/A
Study type: Interventional

Though face-to-face treatment of childhood obesity can be effective, it is time consuming and costly. This study will test whether treatment can be delivered via an Android app and whether such treatment reduces obesity.

NCT ID: NCT01504919 Completed - Clinical trials for Psychosocial Problem

Reducing Cancer Disparities Among Latinos in Texas

Start date: January 2012
Phase: N/A
Study type: Interventional

The goal of this research study is to learn if a wellness program can help improve diet and physical activity levels and encourage smoking cessation in Latino individuals who are overweight.

NCT ID: NCT01308879 Completed - Clinical trials for Mental Health Wellness 1

Effects of Routine Feedback to Clinicians on Youth Mental Health Outcomes: A Randomized Cluster Design

Start date: May 2004
Phase: N/A
Study type: Interventional

The purpose of this clinical trial was to test the hypothesis that clients of clinicians who were scheduled to receive weekly feedback on their clients' progress would improve faster than clients of clinicians who were not scheduled to receive weekly feedback.