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Problem Behavior clinical trials

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NCT ID: NCT05273320 Recruiting - Clinical trials for Intellectual Disability

Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities

N-AND
Start date: March 17, 2022
Phase: Phase 1
Study type: Interventional

Innovative treatments are urgently needed for severe behavioural problems (SBPs) in adults with intellectual and developmental disabilities (IDD). Although a synthetic cannabinoid, nabilone may be a plausible and safe alternative to treat SBP, safety and efficacy of nabilone in people with IDD has never been evaluated. The investigators propose to conduct this first-ever Phase I pre-pilot open-label clinical trial to collect data on the tolerability and safety profile of nabilone in adults with IDD, and explore changes in SBP pre- and post-treatment. The results will inform a next-stage pilot randomized controlled trial, followed by a fully powered trial eventually.

NCT ID: NCT05257863 Recruiting - Cancer Clinical Trials

Development of Machine Learning Models for the Prediction of Complications After Colonic, Colorectal and Small Intestine Anastomosis in Psychiatric and Non-psychiatric Patient Collectives (P-Study)

Start date: May 1, 2022
Phase:
Study type: Observational

Our study aims to lay the basis for a predictive modeling service for postoperative complications and prolonged hospital stay in patients suffering from psychiatric diseases undergoing colorectal surgery. Furthermore, we aim to investigate the impact of preoperative Risk factors, psychiatric and psychosomatic diseases on the outcomes of colorectal surgery and the complications after colorectal surgeries like anastomosis insufficiency via predictive modeling techniques The service mentioned above will be publicly available as a web-based application

NCT ID: NCT05238766 Recruiting - Behavior Problem Clinical Trials

Behavioral Interventions to Increase Parent Adherence With Behavior Plans

Start date: June 21, 2022
Phase: N/A
Study type: Interventional

Many children with autism demonstrate severe problem behavior (SPB) in the form of self-injury, aggression, and disruptive behavior. Conducting a functional analysis and implementing derived treatments can produce effective behavior plans. Nonetheless, skills training and an effective plan may not be sufficient to produce parent adherence. This applied research proposal describes an approach to target the negative maintaining contingencies supporting parent reinforcement of problem behavior (accommodation) and nonadherence. The intervention, borrowed from Acceptance and Commitment Therapy and Behavioral Activation strategies, is matched specifically to the hypothesized function of the problematic caregiver responses (negative reinforcement). Parents who participate in the proposed investigation will be assigned to either the Defuse Experience Accept Live intervention (DEAL) protocol group or treatment as usual. Five 45-min DEAL sessions will 1) introduce caregivers to behavior change strategies that maximize contact with positive-maintaining contingencies related to adherence, while undermining the contingencies that maintain accommodation, and 2) provide caregivers with new treatment-related committed actions that are sensitive to positive changes in parent-child interactions. Within and between participant analyses will be conducted to determine the effectiveness of the DEAL protocol.

NCT ID: NCT05217615 Recruiting - Premature Birth Clinical Trials

Parent Training for Parents of Toddlers Born Very Premature:

ezParent
Start date: August 3, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to test the effects of the ezParent (web-based parent training program) intervention and telephone coaching calls (coach) on parent and child outcomes after 3-, 6-, and 12-months. Parents (n=220) will be randomized using a 2 x 2 factorial design to: (1) ezParent+coach, (2) ezParent, (3) Active Control+coach, or (4) Active control. The investigators will address these aims: 1. Determine the independent and combined effects of ezParent and coaching calls on parent outcomes. H1: The ezParent and ezParent+coach groups will report greater improvements in parenting skills and self-efficacy and reductions in harsh and negative discipline; and exhibit observed improvements in parent-child emotional connection vs. active control H2: There will be a synergistic effect of ezParent and coaching calls on parent outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls. 2. Determine the independent and combined effects of ezParent and coaching calls on child outcomes. H3: The ezParent and ezParent+coach groups will report greater reductions in child behavior problems vs. active control. H4: There will be a synergistic effect of ezParent and coaching calls on child outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls. 3. Determine differences in ezParent engagement with and without coaching calls. Engagement will be assessed by frequency (the number of times parents use the program), activity (proportion of material completed), and duration (amount of time parents use the program). H5: Relative to the ezParent only group, the ezParent+coach group will exhibit higher engagement with the ezParent.

NCT ID: NCT05196724 Recruiting - Behavior Problem Clinical Trials

Holding a Foster Child's Mind in Mind

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to examine the effects of Mentalization Based Therapy (MBT) for foster families in Denmark on child mental health and well-being, parental stress, mental health, and reflective function, parental mind-mindedness and the parent-child relationship.

NCT ID: NCT05177055 Recruiting - Sleep Disorder Clinical Trials

Sleep in Psychiatric Care (SIP): Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)

SIP
Start date: May 23, 2022
Phase: N/A
Study type: Interventional

Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often treated with medication or not at all in psychiatric care, although there exist a plethora of documentation of the effectiveness of sleep interventions. There is also an increase in studies showing effectiveness of sleep-interventions when the sleep disorder co-occurs with psychiatric illness. The recommended treatment for Delayed Sleep-Wake phase disorder is light therapy at gradually advanced timing and/or melatonin administered in order to help phase-advance the circadian rhythm. There is a great gap in the knowledge on how sleep disorders can be treated effectively when they occur comorbid to moderate and severe psychiatric illness. In this project the we therefore seek to investigate the effect of psychological and behavioural, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures.

NCT ID: NCT05102253 Recruiting - Depression Clinical Trials

Acupuncture for Women Victims of Domestic Violence With Psychiatric Sequelae

Start date: July 13, 2022
Phase: N/A
Study type: Interventional

This is an assessor-blinded, randomized controlled trial. A total of 110 women victims of domestic violence aged 18-65 years will be recruited from local community centers and domestic violence shelters (refugee centers). They will be randomly assigned to routine care combined with (n = 55) and without (n = 55) additional acupuncture (TEAS+DCEAS) for 12 weeks. Acupuncture therapy will be conducted with 2 DCEAS sessions at clinics and 3 TEAS sessions at home each week. The primary outcome is the Beck Depression Inventory II (BDI-II) for depression. Secondary outcomes include the 17-item Hamilton Depression Rating Scale (HAMD-17) for depression, Perceived Stress Scale (PSS) for stress, PTSD Check List-Civilian Version (PCL-C) for PTSD symptoms, Insomnia Severity Index (ISI) for sleep and 12-Item Short Form Survey (SF-12) for quality of life. Two 10-ml blood samples will be drawn respectively at baseline and at the end of 12-week study. A generalized linear mixed-effect model will be applied to compare treatment outcomes over time in the two groups and linear regression will be conducted to examine inter-correlations among clinical improvement and changes in biomarker levels.

NCT ID: NCT05093686 Recruiting - Clinical trials for Autism Spectrum Disorder

RUBIES in Educational Settings

RUBIES
Start date: October 26, 2021
Phase: N/A
Study type: Interventional

The proposed three-year pilot randomized trial aims to test the effectiveness of the newly-redesigned paraeducator-delivered RUBI for use in Educational Settings (RUBIES) intervention compared to usual care training in reducing disruptive behavior in 80 elementary-school children with ASD. Given the critical need to understand not just whether, but also how interventions work, this study also will examine paraeducator- and child-level mechanistic pathways of the RUBIES intervention.

NCT ID: NCT05028010 Recruiting - Behavior Problem Clinical Trials

Enhancing the Health Extension Workers Capacity for Promotion of Maternal and Child

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

Background: Maternal and child nutrition is a lingering public health concern, affecting the lives of the most vulnerable individuals, in particular mothers and children. To counteract the burden, the Ethiopian government has applied various strategies, including incorporating the promotion of nutrition as one package of primary health care provided by the health extension workers (HEWs). However, the provider's knowledge, promotion skill, and competency for promoting maternal and child nutrition have not been examined. Moreover, health extension workers have been promoting using the traditional model of education and indicating the need for continuous professional development to strengthen the workforce. Thus, the study is aimed to assess and enhance the health extension worker's capacity in promoting maternal and child nutrition through comprehensive and evidence-based capacity-building training. Methods: A quasi-experimental study will be employed among 92 health extension workers. A baseline study, involving both qualitative and quantitative studies will be conducted to identify the gaps in maternal and child nutrition promotion. The knowledge, promotion as well as counseling skills of the HEWs will be assessed using a self-administered questionnaire and observational checklist, respectively. The intervention will involve training, supportive supervision, and coaching in a real environment. A four-day training will be given, which will be followed by supportive supervision of expert supervisors. Further, the greet, ask, listen, identify, discuss, recommend, and agree counseling model with Pender's health promotion model will be applied to enhance HEWs promotion skill. A post-test aimed at assessing the knowledge and counseling competency will be conducted and the pretest and posttest results will be compared using a t-test. Factors affecting both knowledge and counseling capacity will be assessed using binary logistic and linear regression, respectively. Similarly, a qualitative study will be used to explore promotion skills. Discussion: Given there are problems associated with the knowledge and counseling skills of HEWs in Ethiopia, nutrition education using a well-designed and comprehensive strategy would bring a positive impact on professionals' promotion capacity thereby improving mothers/caregivers' behavior regarding child and maternal nutrition. The evidence will also enforce nutrition programmers and the Amhara regional health bureau to end maternal and child undernutrition.

NCT ID: NCT05014971 Recruiting - Lewy Body Disease Clinical Trials

Telehealth in Lewy Body Dementia

Start date: February 28, 2022
Phase: N/A
Study type: Interventional

Lewy body dementia (LBD) is the 2nd most common neurodegenerative dementia in the US. Optimal care requires an interdisciplinary approach, however often faced barriers include rural residence, limited access to specialists, travel distance, limited awareness of resources, and physical, cognitive, and behavioral impairments making travel to appointments challenging. Delivering interdisciplinary care remotely using video technology has the potential to improve access to care for patients with LBD.