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Problem Behavior clinical trials

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NCT ID: NCT04288947 Completed - Behavior Problem Clinical Trials

Changing the Culture of Disrespect and Abuse in Maternity Care in Kumasi, Ghana

Start date: January 14, 2019
Phase: N/A
Study type: Interventional

Using a public health facility Komfo Anokye Teaching Hospital in Ghana the overall goal of the research is to examine: 1) the feasibility of implementing respectful care modules (RMC-M) in Kumasi, Ghana; 2) whether exposure to RMC-M increases participants perception of respectful maternity care in a public hospital setting in Ghana; and 3) the efficacy of RMC-M in changing midwives' attitudes, behaviors and clinical practice patterns. To achieve Aim 1, qualitative and quantitative study designs will be used to assess for reliability of implementation, usefulness, and patient responsiveness. Based on data collected, feasibility will be examined and the RMC-M will be further modified as needed prior to beginning Aim 2. To achieve Aim 2, a two group study design will be used, with one group of midwives receiving training on the RMC- M and the other not receiving any training. Participants receiving care from these two groups of midwives will be followed through intrapartum and surveyed postpartum to examine their perceptions of the care they received. To achieve Aim 3, a pre-post study design will examine whether expose to a RMC-M changes midwives' attitudes, behaviors, and clinical care of participants during labor and delivery.

NCT ID: NCT04257331 Completed - Clinical trials for Autism Spectrum Disorder

Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China

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

Objectives The primary objective of this study is to evaluate the effectiveness of the SREIA parent training program for families of children with ASD aged three to six years in mainland China. The study will be conducted within the context of routine service provision and assess the effectiveness of SREIA in reducing child behavioral problems as measured by the Externalizing scale of the Child Behavior Checklist (CBCL) for Ages 1.5-5, in comparison to a waitlist control group. Secondary objectives include examining the effectiveness of the SREIA program in reducing ASD symptoms and improving parental and familial outcomes including parental knowledge of ASD and ABA techniques, parenting styles, parental mental health (including stress, anxiety and depression), and family functioning. A process evaluation will be conducted alongside the quasi-experimental trial, the objectives of which are to 1) describe the implementation aspects of the programs with regard to participant involvement, program acceptability, delivery, and sustainability; 2) explore predictors of participant involvement; and 3) examine potential relations between implementation aspects and treatment effects. Background ASD is associated with elevated levels of child emotional and behavior disturbance, which impair child daily functioning and impose challenges to parenting. The SREIA programme is a group-based parent training in China, that has been delivered since 1993 and reached over 10,000 families. However, there is an absence of scientific evaluations of programme effectiveness. This study aims to fill this evidence gap, and the findings will be used to inform future modification, replication, and dissemination of the programme in other parts of China. This study will also contribute to the literature on the effectiveness of parent training programmes for ASD and for families living in low- and middle-income countries. Methods A quasi-experimental design with a mixed-methods approach will be used, involving two consecutive waves of delivery of the SREIA programme. Parent participants will complete demographic and outcome questionnaires at baseline, immediate post-intervention, and 1- or 1.5-year post-intervention (conditional to funding). The implementation components will be assessed by collecting attendance and engagement registry data, facilitators filling out fidelity checklists, research staff observing programme sessions, and parents answering a satisfaction questionnaire. After the programme, some parents, facilitators, and NGO (non-governmental organisation) managers will be invited to take part in qualitative interviews or focus group discussions so as to explore their views about the programme, and to better understand the quantitative data obtained.

NCT ID: NCT04204226 Completed - ASD Clinical Trials

Autism and Disruptive Behavior Trial

Start date: December 17, 2019
Phase: N/A
Study type: Interventional

Investigators seek to transform the delivery of health care to children with autism spectrum disorder (ASD) and behavioral health problems (and their families) by developing an innovative tiered set of interventions. Investigators aim to demonstrate that for children with ASD and disruptive behavior a family navigation-based intervention (autism behavioral health navigation; ABHN) will be feasible and more acceptable to families than brief social work consultation. For children with persistent disruptive behavior despite the social work or ABHN intervention Investigators will evaluate the feasibility and acceptability of adding consultation with an interprofessional team of ASD experts.

NCT ID: NCT04199533 Completed - Clinical trials for Autism Spectrum Disorder

Iterative Redesign of a Behavioral Skills Training Program for Use in Educational Settings

Start date: September 1, 2019
Phase:
Study type: Observational

This study proposes to redesign the RUBI Parent Training program, a low-intensity intervention for youth with autism spectrum disorder and disruptive behavior, for use by school personnel in the classroom. Using a mixed-methods approach, 40 school staff members from 20 elementary schools will be recruited to inform current classroom behavior management practices and RUBI redesign needs.

NCT ID: NCT04142710 Completed - Cancer Clinical Trials

Pragmatic Randomized Control Trial of Telehealth vs Standard Care in Follow-up of Patients With Chronic Conditions

MAO
Start date: February 9, 2019
Phase: N/A
Study type: Interventional

The Norwegian health authorities has initiated a three-year trial of telehealth solutions as part of the treatment of patients with chronic illness in the period 2018-2021. Within the trial, telehealth indicates that patients are followed-up outside health-care facilities using information and communication technologies (ICTs). Patients who are followed up using telehealth solutions can answer questions about their own health and/or perform measurements related to their health (e.g. blood pressure, blood glucose, oxygen measurement, weight) via a tablet according to a personalized schedule. The measurement values are transferred from the measuring devices to a tablet so that the users can easily see them and track their results over time. The results are also transmitted digitally to a follow-up service, a healthcare center with nurses, who contacts the patient when needed. The follow-up service provides medical support and guidance based on the patient's needs and planned follow-up, and will, in consultation with the user, evaluate whether the user should contact the general practitioner (GP) or emergency room. The study population of the trial includes users with comprehensive medical needs, with medium to high risk of worsening of their condition, hospitalization or increased need for health and care services. The evaluation includes three main parts: 1) An effect evaluation which is designed as a randomized control trial, 2) a cost-benefit analysis, and 3) a process evaluation which aims to provide recommendations for how to organize and implement telemedicine in clinical practice. The primary outcomes include physical and mental health state, patient experience and use of health services. The effect evaluation is designed as a pragmatic open label multi-center randomized control trial, with two parallel arms with 300 patients in each arm. Patients are recruited between February 2019 and June 2020.

NCT ID: NCT04113304 Completed - Clinical trials for Disruptive Behavior Disorders

The Parenting Young Children Check-up: Proof-of-Concept Trial

Start date: October 22, 2019
Phase:
Study type: Observational

The Parenting Young Children Check-up (PYCC) is a 3-part system for parents of children with Disruptive Behavior Problems (DBPs). First, at a pediatric visit, parents complete a screener for DBPs and, if reported, go through a tablet-based program to receive feedback and learn about the PYCC. Next, parents receive text messages to connect them to further parent training content. Third, parent training content is delivered via a web-based resource, which includes videos to teach parenting skills. In this proof-of-concept trial, the investigators will examine the acceptability of the tablet-based program and motivation of parents to engage in the PYCC and use the web-based resource. At a pediatric visit, parents will be told about the research opportunity by a staff member before, during, or after their visit. There will be a flier for parents, which will be available for receptionists to include with in-take paperwork. If parents express openness to participating, a research assistant will meet with them, go over the consent form, and let them complete the screener. Parents will complete a demographics questionnaire and the DBP screener. If parents report elevated DBPs, then they will be eligible to further participate. If they are eligible and choose to participate, the research assistant will have them go through the tablet-based program. Next, they will complete a brief questionnaire asking for input on the PYCC. Each of these components will be completed in the Computerized Intervention Authoring System (CIAS). The brief questionnaire is intended to evaluate perceptions of 1) ease of use, 2) usefulness of the information, 3) likability, and 4) intentions to use the PYCC web-based resource. Items will be rated on a 0 (strongly disagree) to 4 (strongly agree) scale. Parents will also verbally answer 6 open-ended interview questions about the program and suggest improvements. Answers will be audio-recorded and transcribed. All participants (whether only completing the screening or both parts of the study) will receive a resource list as well as a list of URLs to access videos on the video-based content on PYCC website. An ID number will need to be entered to use the website and the investigators will track website use. This data collection is not hypothesis driven. Rather, the intent is to gather mixed methods feedback from parents to shape the PYCC program.

NCT ID: NCT04110236 Completed - Clinical trials for Parent-Child Relations

Pilot of Enhanced Child Adult Relationship Enhancement in Pediatric Primary Care

PriCARE
Start date: December 3, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of the enhanced PriCARE intervention in improving parenting capacity, decreasing child behavior problems, and reducing risk of child maltreatment at several primary care clinics in Philadelphia and 2 primary care clinics in North Carolina.

NCT ID: NCT04099173 Completed - Suicidal Ideation Clinical Trials

A Brief Mindfulness-Based Intervention for Suicidal Ideation

MB-SI
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The primary aim of this study is to determine whether a Brief Mindfulness-Based Intervention for Suicidal Ideation (MB-SI) is feasible and safe to implement. The secondary aims are short and longer-term reduction in suicidal ideation (SI) and/or suicide-related behaviors (SRBs) as well as improvements in mindfulness and emotional regulation measures compared to Treatment as Usual (TAU).

NCT ID: NCT04097431 Completed - Aggression Clinical Trials

Identifying Precursors to Severe Problem Behavior

Start date: October 7, 2019
Phase: N/A
Study type: Interventional

The primary objective of this research is to evaluate the escalating sequence of behavior that culminates in severe problem behavior (SPB, such as aggression, self-injury, and disruption). To do so, we will investigate the precursors of SPB, which are defined as behaviors that are not as severe or dangerous as SPB, but that reliably precede the occurrence of SPB. Identifying and knowing about these precursors has the potential to complement existing behavioral treatments, making treatments safer (because SPB may occur to a lesser extent or not at all). However, existing research on precursors has been opportunistic and lacks systematic study. This research will examine methods to identify and better understand precursors.

NCT ID: NCT04091633 Completed - ADHD Clinical Trials

School Health Implementation Network: Eastern Mediterranean

SHINE
Start date: October 7, 2019
Phase: N/A
Study type: Interventional

Background An estimated 10-20% of children globally are affected by a mental health problem. Child mental health has been identified as a priority issue by the World Health Organization's Eastern Mediterranean Regional Office (WHO EMRO). Following consultations with international and regional experts and stakeholders, WHO EMRO developed an evidence-based School Mental Health Program (SMHP), endorsed by WHO EMRO member countries, including Pakistan. The federal and provincial health departments in Pakistan made recommendations for a phased implementation of the SMHP in a pilot district. In the formative phase of this program, a number of implementation challenges were identified by the stakeholders. Broadly, these included the need to operationalize and adapt the existing components of the intervention to the local context and to develop sustainable mechanisms for delivery of quality training and supervision. Informed by the results of a formative phase investigations, the SHINE scale-up research team adapted the SMHP (henceforth called Conventional SMHP or cSMHP) to address these implementation challenges. The enhanced version of the intervention is called Enhanced School Mental Health Program (eSMHP). Enhancements to cSMHP have occurred at two levels: A) Content enhancements, such as a collaborative care model for engaging parents/primary caregivers, strategies for teacher's wellbeing, and adaptation and operationalization of particular clinical intervention strategies and B) Technological enhancements which include adaptation of the training manual for delivery using an online training platform, and a 'Chat-bot' to aid the implementation of intervention strategies in classroom settings. Objectives The primary objective of the study is to evaluate the effectiveness of eSMHP in reducing socio-emotional difficulties in school-going children, aged 8-13, compared to cSMHP in Gujar Khan, a rural sub-district of Rawalpindi, Pakistan. The secondary objectives are to compare the cost-effectiveness, acceptability, adoption, appropriateness (including cultural appropriateness), feasibility, penetration and sustainability of scaled-up implementation of eSMHP and cSMHP. It is hypothesized that eSMHP will prove to be both more effective and more scalable than cSMHP. Study population The research is embedded within the phased district level implementation of the cSMHP in Rawalpindi, Pakistan. The study population will consist of children of both genders, aged 8-13 (n=960) with socio-emotional difficulties, studying in rural public schools of sub-district Gujar Khan in Rawalpindi. Design The proposed study design is a cluster randomized controlled trial (cRCT), embedded within the conventional implementation of the SMHP. Following relevant ethics committees and regulatory approvals, 80 eligible schools, stratified by gender, will be randomized into intervention and control arms with a 1:1 allocation ratio. Following informed consent from the parent/ primary caregiver, children will be screened for socio-emotional difficulties using Strengths and Difficulties Questionnaire (SDQ). 960 children scoring > 12 on the teacher-rated SDQ total difficulty scores and > 14 on the parent-rated SDQ total difficulty scores will be recruited and equally randomized into intervention and control arms (480 in each arm). Teachers in the intervention arm will receive training in eSMHP, whereas teachers in the active control will be trained in cSMHP. Trained teachers will deliver the program to children in their respective arms. Outcome measures Primary Outcome: The primary outcome is reduction in socio-emotional total difficulties scores, measured with the parent-rated SDQ, 9 months after commencing intervention delivery. Secondary Outcomes: Implementation data on acceptability, adoption, appropriateness (including cultural appropriateness), feasibility, penetration and sustainability outcomes will be collected from children, parents/primary caregivers, head teachers and teachers. In addition, data will be collected on self-reported Psychological Outcome Profiles (PSYCHLOPS)-KIDS to measure progress on psycho-social problems and wellbeing; annual academic performance; classroom absenteeism, stigmatizing experiences and parent-teacher interaction. Data on teachers' sense of efficacy and subjective well-being, and on the schools' psychosocial environment profile will be collected. All secondary outcome data will be collected at baseline and 9 months after commencing intervention delivery. Outcomes will be analyzed on an intention to treat basis. The role of various factors as potential mediators and moderators eSMHP effectiveness will be explored. Cost-effectiveness evaluation of SMHP shall be evaluated in terms of costs associated with implementation of eSMHP compared with cSMHP.