Dataset Information

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Oppositional defiant disorder (ODD) is a major mental health concern and highly prevalent among children living in poverty-impacted communities. Despite that treatments for ODD are among the most effective, few children living in poverty receive these services due to substantial barriers to access, as well as difficulties in the uptake and sustained adoption of evidence-based practices (EBPs) in community settings. The purpose of this study is to examine implementation processes that impact uptake of an evidence-based practice for childhood ODD, and the impact of a Clinic Implementation Team (CIT)-driven structured adaptation to enhance its fit within the public mental health clinic setting. METHODS/DESIGN:This study, a Hybrid Type II effectiveness-implementation research trial, blends clinical effectiveness and implementation research methods to examine the impact of the 4Rs and 2Ss Multiple Family Group (MFG) intervention, family level mediators of child outcomes, clinic/provider-level mediators of implementation, and the impact of CITs on uptake and long-term utilization of this model. All New York City public outpatient mental health clinics have been invited to participate. A sampling procedure that included randomization at the agency level and a sub-study to examine the impact of clinic choice upon outcomes yielded a distribution of clinics across three study conditions. Quantitative data measuring child outcomes, organizational factors and implementation fidelity will be collected from caregivers and providers at baseline, 8, and 16 weeks from baseline, and 6 months from treatment completion. The expected participation is 134 clinics, 268 providers, and 2688 caregiver/child dyads. We will use mediation analysis with a multi-level Structural Equation Modeling (SEM) (MSEM including family level variables, provider variables, and clinic variables), as well as mediation tests to examine study hypotheses. DISCUSSION:The aim of the study is to generate knowledge about effectiveness and mediating factors in the treatment of ODDs in children in the context of family functioning, and to propose an innovative approach to the adaptation and implementation of new treatment interventions within clinic settings. The proposed CIT adaptation and implementation model has the potential to enhance implementation and sustainability, and ultimately increase the extent to which effective interventions are available and can impact children and families in need of services for serious behavior problems. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02715414 . Registered on 3 March 2016.

SUBMITTER: Acri M

PROVIDER: S-EPMC5716003 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial.

Acri Mary M Hamovitch Emily E Mini Maria M Garay Elene E Connolly Claire C McKay Mary M

Trials 20171204 1

<h4>Background</h4>Oppositional defiant disorder (ODD) is a major mental health concern and highly prevalent among children living in poverty-impacted communities. Despite that treatments for ODD are among the most effective, few children living in poverty receive these services due to substantial barriers to access, as well as difficulties in the uptake and sustained adoption of evidence-based practices (EBPs) in community settings. The purpose of this study is to examine implementation process ...[more]

PMID: 29202867

Similar Datasets

Project description:The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU) can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges.This study is a randomized controlled trial (RCT) with blinded assessment comparing Standard Care (SC) with a novel Family Nurture Intervention (FNI). FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA) and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1) In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2) Outside the isolette during holding and feeding via the Calming Cycle; and 3) through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA), maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group).The FNI is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of preterm infants, as well as infant-mediated sensory experiences of the mother. Consequently, we are enlarging the testing of preterm infant neurodevelopment beyond that of previous research to include outcomes related to mother-infant interactions and mother-infant co-regulation. Our primary objective is to determine whether repeated engagement of the mother and her infant in the intervention's calming activities will improve the infant's developmental trajectory with respect to multiple outcomes. Our secondary objective is to assess the effectiveness of FNI in the physiological and psychological co-regulation of the mother and infant. We include aspects of neurodevelopment that have not been comprehensively measured in previous NICU interventions.ClinicalTrials.gov: NCT01439269.

Project description:BackgroundMany children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice.Methods and designThis paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance care visits at least twice a year, and an asthma action plan. Cost-effectiveness of the intervention was also measured.DiscussionTwenty-two practices (66 physicians) were randomized (11 per treatment group), and 950 families with a child 3-12 years old with persistent asthma were enrolled. A description of the coaching intervention is presented.

Project description:Between 30 and 40 % of patients with severe injuries receive treatment at non-trauma centers (under-triage), largely because of physician decision making. Existing interventions to improve triage by physicians ignore the role that intuition (heuristics) plays in these decisions. One such heuristic is to form an initial impression based on representativeness (how typical does a patient appear of one with severe injuries). We created a video game (Night Shift) to recalibrate physician's representativeness heuristic in trauma triage.We developed Night Shift in collaboration with emergency medicine physicians, trauma surgeons, behavioral scientists, and game designers. Players take on the persona of Andy Jordan, an emergency medicine physician, who accepts a new job in a small town. Through a series of cases that go awry, they gain experience with the contextual cues that distinguish patients with minor and severe injuries (based on the theory of analogical encoding) and receive emotionally-laden feedback on their performance (based on the theory of narrative engagement). The planned study will compare the effect of Night Shift with that of an educational program on physician triage decisions and on physician heuristics. Psychological theory predicts that cognitive load increases reliance on heuristics, thereby increasing the under-triage rate when heuristics are poorly calibrated. We will randomize physicians (n?=?366) either to play the game or to review an educational program, and will assess performance using a validated virtual simulation. The validated simulation includes both control and cognitive load conditions. We will compare rates of under-triage after exposure to the two interventions (primary outcome) and will compare the effect of cognitive load on physicians' under-triage rates (secondary outcome). We hypothesize that: a) physicians exposed to Night Shift will have lower rates of under-triage compared to those exposed to the educational program, and b) cognitive load will not degrade triage performance among physicians exposed to Night Shift as much as it will among those exposed to the educational program.Serious games offer a new approach to the problem of poorly-calibrated heuristics in trauma triage. The results of this trial will contribute to the understanding of physician quality improvement and the efficacy of video games as behavioral interventions.clinicaltrials.gov; NCT02857348 ; August 2, 2016.

Project description:BACKGROUND:Balance and trunk control are often impaired in individuals with multiple sclerosis (MS). Interventions addressing these issues are needed. OBJECTIVE:The objective of this study was to compare the immediate and long-term effects of a 6-week individualized, group-based, comprehensive core stability intervention (GroupCoreDIST) with standard care on balance and trunk control in individuals with MS. DESIGN:This study was a prospective, assessor-masked, randomized controlled trial. SETTING:The GroupCoreDIST intervention was conducted by 6 physical therapists in 6 municipalities in Norway. Standard care included the usual care for individuals with MS in the same municipalities. Assessments at all time points took place at a Norwegian hospital. PARTICIPANTS:Eighty people with Expanded Disability Status scores of 1 to 6.5 participated in this trial. INTERVENTION:Randomized, concealed allocation was used to assign the participants to the GroupCoreDIST intervention (n = 40) or to standard care (n = 40). The GroupCoreDIST intervention was conducted with groups of 3 participants (1 group had 4 participants), for 60 minutes 3 times per week. MEASUREMENTS:Assessments were undertaken at baseline and at weeks 7, 18, and 30. Outcomes were measured with the Trunk Impairment Scale-Norwegian Version, Mini Balance Evaluation Systems Test, and Patient Global Impression of Change-Balance. Repeated-measures mixed models were used for statistical analysis. RESULTS:One individual missed all postintervention tests, leaving 79 participants in the intention-to-treat analysis. GroupCoreDIST produced significant between-group effects on the mean difference in the following scores at 7, 18, and 30 weeks: for Trunk Impairment Scale-Norwegian Version, 2.63 points (95% confidence interval [CI] = 1.89-3.38), 1.57 points (95% CI = 0.81-2.33), and 0.95 point (95% CI = 0.19-1.71), respectively; for Mini Balance Evaluation Systems Test, 1.91 points (95% CI = 1.07-2.76), 1.28 points (95% CI = 0.42-2.15), and 0.91 points (95% CI = 0.04-1.77), respectively; and for Patient Global Impression of Change-Balance, 1.21 points (95% CI = 1.66-0.77), 1.02 points (95% CI = 1.48-0.57), and 0.91 points (95% CI = 1.36-0.46), respectively. LIMITATIONS:Groups were not matched for volume of physical therapy. CONCLUSIONS:Six weeks of GroupCoreDIST improved balance and trunk control in the short and long terms compared with standard care in individuals who were ambulant and had MS. The intervention is an effective contribution to physical therapy for this population.

Dataset Information

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial.

Publications

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets