Active clinical trials for "Problem Behavior"

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.

After developing and pilot testing the training program, including the CogBals software, a 3-arm, single-blinded, randomized controlled trial is used to recruit 81 participants and then randomly allocated to the cognitive and balance dual task training group (COG&BAL), the balance training group (BAL), and the treatment as usual group. The first two training groups (COG&BAL, BAL) receive training for 60 minutes in a group format, 2 times weekly, for 12 weeks. All participants will be assessed at baseline and posttest. The primary outcome is balance function and secondary outcomes are cognitive functions and the muscular endurance of lower extremities.

Maternal depression influences the development of children's behavior problems and vice versa; however most interventions singularly address maternal depression or children's behavior problems rather than both. This project assesses the efficacy of an intervention that treats both mothers and children in an integrated manner. Effects are expected to disrupt the reciprocal relations that perpetuate maternal and child mental health problems over time.

Agitation and aggression impose a tremendous burden on the individuals living with dementia, their families, caregivers, and healthcare systems. Neuropsychiatric symptoms of dementia (NPS) affect up to 80% of patients with Alzheimer's dementia (AD). The mechanisms of agitation in AD are poorly understood and the current interventions are only modestly effective while having serious adverse effects. In this study, the investigators propose to assess the mechanisms and treatment of neuropsychiatric symptoms in AD with the use of non-invasive, brain stimulation approaches. By applying magnetic stimulation to the surface of the head (transcranial magnetic stimulation - TMS) combined with electroencephalography (EEG), the investigators will be able to study the mechanisms of agitation and advance our understanding of AD. Further, the investigators will evaluate if transcranial direct current stimulation (tDCS) is effective to treat agitation dementia.

This is a multi-site, double-blind, parallel group, randomized, placebo-controlled study of 140 participants comparing oral purified cannabidiol isolate (CBD) with placebo in reducing Severe Behavioral Problems (SBP) at 8 weeks in children aged 6 - 18 years with Intellectual Disability (ID). Eligible participants will be randomized 1:1 to receive either CBD or placebo.

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.

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.

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.

Children with emotional and behavioural difficulties (EBD) experience disproportionate social, family and academic impairment and have between two to five times increased likelihood of developing an anxiety disorder, mood disorder or other severe mental illness in adolescence and adulthood. There is a close association between parental depression and the emergence and maintenance of childhood EBD that is likely bidirectional. Parents of children with EBD experience disproportionate stress, increasing their risk for depression; yet chronic and untreated parental depression is associated with the emergence of child EBD in the first place. Therefore, designing targeted and effective assessment and treatment for parents of children with EBD that take into account parents' depression is necessary. Of pressing concern, first-line Behavioral Parent Training (BPT) treatments for parents of children with EBD are not tailored to parent's mental health needs, which may be why upwards of 40 percent of parents and children treated in these programs fail to sufficiently benefit. Existing research highlights emotional and cognitive factors that may differentiate depressed parents from non-depressed parents that may be treatment targets to improve outcomes for depressed parents and children. The main aim of the proposed project is to evaluate the feasibility and acceptability of a novel targeted treatment for depressed parents of children with EBD, along with adherence to study protocol. The investigators will use the results of the pilot study to make key modifications to study procedures and the treatment itself to increase the success of a future randomized controlled trial (RCT) to test treatment efficacy. The investigators hypothesize that: Recruitment will be feasible. The intervention will be acceptable, and there will be a high rate of adherence to study protocol.

RATIONALE Problems of children with disruptive (i.e., oppositional, impulsive, hyperactive, and aggressive) behaviors often grow into chronic disorders and subsequent adverse outcomes, such as school drop-out, delinquency, substance use, anti-social personality disorder, and depression. Ideally, treatment should prevent the escalation of problems, reduce the need for long and intensive or potentially harmful treatments (such as antipsychotics), and lower societal costs. Parent training has a strong effect on disruptive behaviors, however, only few families receive empirically-supported parent training. Programs are typically long and waiting lists are therefore common. Also, most existing interventions are not tailored to individual parental needs. There is thus an urgent need for brief, accessible, and individually-tailored programs. OBJECTIVES This project aims to increase the effective use of parent training for children with disruptive behaviors by (1) examining short and long-term effectiveness of a new, brief, individual, and individually-tailored parent training program with optional booster sessions to prevent relapse, compared to care as usual (CAU) in a randomized controlled trial; (2) assessing the cost-effectiveness of the brief parent training program compared to CAU. STUDY DESIGN A randomized controlled trial (RCT) with two arms will be used. Referred children and their parents will be randomly assigned (equal randomization) to (a) three sessions of brief parent training, with optional single booster sessions up to one year after the training, or (b) CAU, as regularly provided by the mental health centers involved. The study outcomes will be measured at baseline before the brief training (T0), one week after the brief training (T1), six months after T1 (T2), and twelve months after T1 (T3). For parents in the control condition, similar measurement time points will be used: before any intervention (T0), eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3). STUDY POPULATION Children with disruptive behaviors that have been referred at one of six Dutch mental health centers. INTERVENTION Parents in the intervention arm will receive a short, individualized, three-session training primarily aimed at reducing children's disruptive behaviors. It exists of two (bi)weekly individually tailored training sessions of two hours and a third session of one hour in which the training will be evaluated, and maintenance training will be provided. After that, parents wishing to receive additional support can receive single booster sessions maximum once every four weeks and/or receive care as usual. Parents in the control arm will receive care as usual for children's disruptive behavior. The treatments in both arms will be fully embedded in Dutch routine mental health care. MAIN STUDY PARAMETERS The primary outcome will be the severity of four individual target disruptive behaviors that parents want to address in the training. Secondary outcomes will be parent-reported disruptive behaviors, parent-reported child well-being, parent-reported parenting behaviors, masked audio records of mealtime routines to measure parent and child behavior, parent-reported parenting stress, parent-reported parenting self-efficacy, parent-reported parental attitude towards their child, consumption and cost of mental health care, and health state utility values. We will furthermore measure evaluations of the program by parents and therapists and explore whether parental attachment, parental psychopathology, parental reward responsivity, parent-reported child reward responsivity and punishment sensitivity moderate the intervention effects.