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Behavioral Symptoms clinical trials

View clinical trials related to Behavioral Symptoms.

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NCT ID: NCT05591820 Recruiting - Behavioral Symptoms Clinical Trials

A Randomized Controlled Trial on Brief Behavioral Parent Training

PAINT-GGZ
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

RATIONALE: The access to and uptake of evidence-based behavioral parent training for children with behavioral difficulties (i.e., oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behavior) are currently limited because of a scarcity of certified therapists and long waiting lists. These problems are in part due to the long and sometimes perceived as rigid nature of most evidence-based programs and result in few families starting behavioral parent training and high dropout rates. Brief and individually tailored parenting interventions may reduce these problems and make behavioral parent training more accessible. OBJECTIVES: This project aims to increase the effective use of parent training for children with behavioral difficulties by (1) examining short and longer-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); (2) assessing the cost-effectiveness of the brief parent training program compared to CAU. STUDY DESIGN: In this two-arm, multi-center randomized controlled trial (RCT), parents are randomly assigned (1:1 ratio) to either (a) three sessions of brief behavioral parent training with optional booster sessions, or (b) CAU, as regularly provided by the involved mental healthcare centers. The study outcomes are measured at baseline before randomization (T0), one week after the third session for parents in the brief behavioral parent training arm and eight weeks after T0 for parents in the CAU arm (first posttreatment measurement, T1), six months after T1 (second posttreatment measurement, T2) and twelve months after T1 (third posttreatment measurement, T3). STUDY POPULATION: Parents of children who experience behavioral difficulties in the home setting and were referred to a child mental healthcare center. INTERVENTION: Parents in the intervention arm receive a short, individualized, three-session training primarily aimed at reducing children's behavioral problems. 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 receive care as usual for children's behavioral problems. The treatments in both arms are fully embedded in Dutch routine mental health care. MAIN STUDY PARAMETERS: The primary outcome is the severity of four individual target behavioral difficulties that parents want to address in the training. Secondary outcomes are parent-reported behavioral difficulties, 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 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.

NCT ID: NCT05478681 Recruiting - Alzheimer Disease Clinical Trials

Home-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)

Start date: April 17, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to assess acceptability, and safety of providing tDCS to ADRD patients with behavioral symptoms and to assess the efficacy of tDCS for ADRD-related symptoms, mainly behavioral symptoms.

NCT ID: NCT05454293 Recruiting - Depressive Symptoms Clinical Trials

One Talk at a Time: A Racial-ethnic Socialization Intervention for Diverse Families

OTAAT
Start date: August 24, 2022
Phase: N/A
Study type: Interventional

This study is a randomized effectiveness trial that tests the online delivery of a video-based intervention (One Talk at a Time (OTAAT)) relative to a control group over a one-year span. Hypotheses include: 1.) The OTAAT intervention will increase parental motivation to engage in racial-ethnic socialization (RES) conversations, their skills and confidence in having these conversations, and the frequency and quality of these conservations; 2.) The OTAAT intervention will increase youth reports of their coping with discrimination, perceived efficacy in coping with discrimination in the future, ethnic-racial identity, and youth mental and academic outcomes; 3.) Greater parental discrimination and youth discrimination will moderate links between OTAAT intervention and parental ethnic-racial motivation + competency as well as youth ethnic-racial identity, coping, and psychosocial outcomes.

NCT ID: NCT05452954 Completed - ADHD Clinical Trials

Psychosocial ADHD Interventions - Brief Parent Training

PAINT
Start date: March 16, 2021
Phase: N/A
Study type: Interventional

This pilot study investigates a new, easily applicable, individually tailored first-line behavioral training for parents of children (4-12 years) with (symptoms of) ADHD, that will be provided in an early stage, before other treatments have been applied. In this pilot study the feasibility of the newly developed intervention will be evaluated by exploring program acceptability, including client satisfaction, recruitment, retention, treatment fidelity and therapist satisfaction. Also acceptability of potential outcome measures will be explored, including preliminary tests of efficacy.

NCT ID: NCT05384704 Active, not recruiting - Depression Clinical Trials

A Single Group Study of Empower@Home-an Internet Cognitive Behavioral Therapy Intervention

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

This is a single group study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 300 older adults throughout the state of Michigan to test the effectiveness of Empower@Home with older adults. The intervention will take approximately 10 weeks to complete. Participants will have lower levels of depression after completing the intervention than before enrollment. Participants will be able to use the internet-based platform with minimal support.

NCT ID: NCT05353049 Active, not recruiting - Patient Engagement Clinical Trials

How to Bathe a Person With Dementia? A Bathing Intervention Based on Basale Stimulation® for People With Moderate to Severe Dementia

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Brief summary Resisted behaviours that occur during showering of People with Dementia (PwD) cause greater discomfort for caregivers and may occur as a result of embarrassment and shame that the person with dementia may be experiencing or even due to a moment of confusion or anxiety. Therefore, it is considered particularly relevant and necessary to provide information and strategies to caregivers of PwD in order to manage the behavioural alterations produced during the shower. One of the strategies currently used in clinical practice to improve the relationship between caregivers and users is the implementation of the Basale stimulation® concept. The stimuli applied from Basale Stimulation® are related to 3 basic areas of development: somatic, vestibular and vibrational. In relation to the development of the showers, they will be carried out from the application of relaxing somatic modelling connected to the somatic area. The aim of this study is to analyse the efficacy of an intervention based on the relaxing somatic modelling technique, framed within the Basale Stimulation® concept, to reduce behavioural disturbances and increase the involvement of the person with moderate to severe dementia during assisted showering. The main caregivers of the PwD, who meet the inclusion criteria will be contacted by sending a study information sheet and an informed consent form. All family members will receive a call to clarify the concepts explained and the study methodology to be carried out. The grooming sessions of all users whose relatives have signed the informed consent form, will be videotaped and a trained technician will fill in the questionnaires for each session based on the analysis of the videos of each intervention. Six intervention sessions will be carried out with each user. An alternating treatment design will be used, applying condition A or B randomly and then counterbalancing. Condition A corresponds to a traditional shower according to the long-term care bathing and grooming protocol and condition B corresponds to the use of relaxing somatic modelling within Basale Stimulation®. The first result obtained will be an increase in the appearance and frequency of behaviours that increase the engagement of the PwD and a decrease in the appearance and frequency of disengagement behaviours during the shower activity in the Basale Stimulation® application sessions. This result will be measured with the Involvement Register (RIE) (García-Soler et al., 2014), adding the measure of frequency of involvement behaviours on a likert scale. The second expected outcome will be the decrease in the occurrence, frequency and intensity of behavioural disturbances during the Basale Stimulation®-based intervention showers. This outcome will be measured with a questionnaire based on the Neuropsychiatric Inventory Questionnaire (NPI-Q)(Boada et al., 2002) and the Agitated Behavior in Dementia scale (ABID) (Logsdon et al., 1999), recording the number of times a disruptive behaviour appears, the frequency with which it appears during the shower, and the intensity of the behaviour on a Likert scale. In addition, the user's functional status measured with the Barthel Index, his cognitive status measured with the Mini-Mental State Examination and his behaviour through the Agitation Inventory of the Elderly will be taken into account. Intervention description The relaxing somatic modelling technique will be applied, framed within the concept of Basal Stimulation®. To do this, the user remains seated and the parts of the body that are not being washed at that moment are covered with a towel, favouring the preservation of the user's privacy. The user is lathered up with soft mittens previously moistened with lukewarm water and lathered up. This process shall be carried out starting from the shoulder in a proximal to distal direction on the upper limbs, lower limbs and trunk (taking into account the sagittal anatomical plane) and in a cephalic to caudal direction (taking into account the transverse anatomical plane). Subsequently, rinsing is carried out following the same guidelines as described above, using moistened soft mittens. Finally, intimate hygiene is performed with a disposable soapy sponge and the soap is rinsed off again with moistened soft terrycloth mittens. Throughout the whole process, the activity is explained to the user.

NCT ID: NCT05322343 Recruiting - Depression Clinical Trials

Biobank and Brain Health in Bordeaux.

B-cube
Start date: March 22, 2022
Phase:
Study type: Observational [Patient Registry]

B cube is a new generation cohort to study the determinants and natural history of brain aging, using molecular epidemiology, in a representative sample (N=2000) of the general population from the age of 55 (the approximate age of onset of the first cognitive disorders and a target population particularly receptive to prevention messages). Special interest will be given to nutrition, a promising environmental exposure for prevention.

NCT ID: NCT05272501 Completed - Dementia Clinical Trials

CAlming Touch for People With Agitation or Other Behavioural Symptoms of DEMentia - A Randomized Feasibility Trial

CADEM
Start date: October 4, 2021
Phase: N/A
Study type: Interventional

Dementia is an increasing health challenge among elderly citizens in Denmark. An estimated 87,000 Danes live with dementia, and this number is expected to increase to 130,000 in 2030. Psychiatric symptoms and behavioral changes decrease quality of life for patients and their spouses and is a challenge for caretakers. Behavior changes include agitation which can be divided in four sub-groups: 1) physical aggression, 2) physical non-aggression, 3) verbal aggression, and 4) verbal non-aggression. Pharmaceutical management of behavioral changes is common and may be associated with negative side-effects including drowsiness and falls. Though non-pharmaceutical interventions such as music, massage and social activities have been recommended the underlying evidence is limited. In this randomized feasibility trial, we will investigate the feasibility and acceptability of therapeutic touch aiming to reduce agitated behavior in people living with dementia in a nursing home that specializes in the care of people living with severe dementia. The success criteria of this randomized feasibility trial are as follows: 1. Nursing home residents can be recruited and accept the treatment 'CAlming Touch for People with Agitation or Other Behavioral Symptoms of DEMentia' (CADEM) and complete the feasibility project's test protocol. 2. The treatment concept, which involves the nursing staff in charge of the follow-up treatment, can be implemented in practice. 3. The treatment (CADEM) shows a tendency towards less restless and aggressive behavior for demented citizens evaluated based on a validated measuring tool.

NCT ID: NCT05223842 Completed - Depression Clinical Trials

Family Promoting Positive Emotions Pilot Study

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Anhedonia is characterized by loss of interest or pleasure. The proposed pilot study would be the first to test an innovative, neuroscience-informed intervention in mothers reporting depressive symptoms and stress to enhance positive emotionality with the goal of preventing anhedonia and associated emotional disturbances in their children. This study will recruit dyads (mothers and their children) for the intervention.

NCT ID: NCT05184907 Completed - Opioid Use Disorder Clinical Trials

Effects of RME on Engagement in Buprenorphine Treatment

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

The investigators will conduct a Randomized Controlled Trial (RCT) comparing the Remote Motivational Enhancement (RME) coaching sessions + MindWell screenings arm to an Information-only + MindWell screenings arm on early engagement in treatment support services, as measured by overall action plan initiation.