Randomized Trial of First-Line Behavioral Intervention to Reduce Need for Medication in Children with ADHD.
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ABSTRACT:
SUBMITTER: Coles EK
PROVIDER: S-EPMC7018583 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:To test cognitive behavioral therapy (CBT) for persistent attention-deficit hyperactivity disorder (ADHD) symptoms in a sample of medication-treated adolescents.Forty-six adolescents (ages 14-18), with clinically significant ADHD symptoms despite stable medication treatment were randomly assigned to receive CBT for ADHD or wait list control in a cross-over design. Twenty-four were randomized to CBT, 22 to wait list, and 15 crossed-over from wait list to CBT. A blind independent evaluator (IE) rated symptom severity on the ADHD Current Symptom Scale, by adolescent and parent report, and rated each subject using the Clinical Global Impression Severity Scale (CGI), a global measure of distress and impairment. These assessments were performed at baseline, 4-months (post-CBT or post wait list), and 8-months (post-treatment for those originally assigned to the wait list condition and 4-month follow-up for those originally assigned to CBT).http://clinicaltrials.gov/show/NCT01019252.Using all available data, mixed effects modeling, and pooling for the wait list cross-over, participants who received CBT received a mean score 10.93 lower on the IE-rated parent assessment of symptom severity (95% CI: -12.93, -8.93; p < .0001), 5.24 lower on the IE-rated adolescent assessment of symptom severity (95% CI: -7.21, -3.28; p < .0001), and 1.17 lower IE-rated CGI (95% CI: -1.39, -.94; p < .0001). Results were consistent across 100 multiple imputations (all p < .0001). There was a greater proportion of responders after CBT by parent (50% vs. 18%, p = .00) and adolescent (58% vs. 18% p = .02) report.This study demonstrates initial efficacy of CBT for adolescents with ADHD who continued to exhibit persistent symptoms despite medications.
| S-EPMC5026858 | biostudies-literature
Project description:BackgroundThe 2017 ACC-AHA Hypertension Guideline recommends initiation of antihypertensive drug therapy based on blood pressure (BP) and an assessment of global cardiovascular disease (CVD) risk, but intensive lifestyle modification may lower BP to below recommended thresholds for treatment in some patients.MethodsWe examined the effects of lifestyle modification on calculated CVD risk and on the indications for BP-lowering medications in individuals with untreated hypertension. Participants included 144 adults with BP 130-160/80-99 mm Hg who were randomized to 16 weeks of DASH (Dietary Approaches to Stop Hypertension) diet plus behavioral weight management (DASH + WM), DASH diet alone (DASH), or Usual Care.ResultsThe mean age of the study cohort was 52.0 years; the average baseline BP was 138 ± 9/86 ± 6 mm Hg. The 10-year CVD risk, as calculated by the Pooled Cohort Equations, was 5.7%. The adjusted 10-year risk fell to 4.4% in the DASH + WM group and to 5.0% in the DASH arm, but was not significantly changed (5.7%) in the Usual Care controls. The percentages of participants with guideline-based indications for antihypertensive drugs fell from 51% to 18% in the DASH + WM group and from 48% to 22% in the DASH group; and did not change significantly (49% to 44%) in the Usual Care group (P = 0.010 for the active intervention groups vs. Usual Care; P = 0.042 for DASH + WM vs. DASH).ConclusionsThese data demonstrate that in men and women with mildly elevated BP, lifestyle interventions can lower the calculated CVD risk and dramatically decrease the number of individuals for whom guideline-directed antihypertensive medication is indicated.
| S-EPMC8557445 | biostudies-literature
Project description:BackgroundThe use of a 'do not interrupt' vest during medication administration rounds is recommended but there have been no controlled randomized studies to evaluate its impact on reducing administration errors. We aimed to evaluate the impact of wearing such a vest on reducing such errors. The secondary objectives were to evaluate the types and potential clinical impact of errors, the association between errors and several risk factors (such as interruptions), and nurses' experiences.MethodsThis was a multicenter, cluster, controlled, randomized study (March-July 2017) in 29 adult units (4 hospitals). Data were collected by direct observation by trained observers. All nurses from selected units were informed. A 'Do not interrupt' vest was implemented in all units of the experimental group. A poster was placed at the entrance of these units to inform patients and relatives. The main outcome was the administration error rate (number of Opportunities for Error (OE), calculated as one or more errors divided by the Total Opportunities for Error (TOE) and multiplied by 100).ResultsWe enrolled 178 nurses and 1346 patients during 383 medication rounds in 14 units in the experimental group and 15 units in the control group. During the intervention period, the administration error rates were 7.09% (188 OE with at least one error/2653 TOE) for the experimental group and 6.23% (210 OE with at least one error/3373 TOE) for the control group (p = 0.192). Identified risk factors (patient age, nurses' experience, nurses' workload, unit exposition, and interruption) were not associated with the error rate. The main error type observed for both groups was wrong dosage-form. Most errors had no clinical impact for the patient and the interruption rates were 15.04% for the experimental group and 20.75% for the control group.ConclusionsThe intervention vest had no impact on medication administration error or interruption rates. Further studies need to be performed taking into consideration the limitations of our study and other risk factors associated with other interventions, such as nurse's training and/or a barcode system.Trial registrationThe PERMIS study protocol (V2-1, 11/04/2017) was approved by institutional review boards and ethics committees (CPP Ile de France number 2016-A00211-50, CNIL 21/03/2017, CCTIRS 11/04/2016). It is registered at ClinicalTrials.gov (registration number: NCT03062852 , date of first registration: 23/02/2017).
| S-EPMC8383384 | biostudies-literature
Project description:Attention-deficit/hyperactivity disorder (ADHD) in adulthood is a prevalent, distressing, and impairing condition that is not fully treated by pharmacotherapy alone and lacks evidence-based psychosocial treatments.To test cognitive behavioral therapy for ADHD in adults treated with medication but who still have clinically significant symptoms.Randomized controlled trial assessing the efficacy of cognitive behavioral therapy for 86 symptomatic adults with ADHD who were already being treated with medication. The study was conducted at a US hospital between November 2004 and June 2008 (follow-up was conducted through July 2009). Of the 86 patients randomized, 79 completed treatment and 70 completed the follow-up assessments.Patients were randomized to 12 individual sessions of either cognitive behavioral therapy or relaxation with educational support (which is an attention-matched comparison).The primary measures were ADHD symptoms rated by an assessor (ADHD rating scale and Clinical Global Impression scale) at baseline, posttreatment, and at 6- and 12-month follow-up. The assessor was blinded to treatment condition assignment. The secondary outcome measure was self-report of ADHD symptoms.Cognitive behavioral therapy achieved lower posttreatment scores on both the Clinical Global Impression scale (magnitude -0.0531; 95% confidence interval [CI], -1.01 to -0.05; P = .03) and the ADHD rating scale (magnitude -4.631; 95% CI, -8.30 to -0.963; P = .02) compared with relaxation with educational support. Throughout treatment, self-reported symptoms were also significantly more improved for cognitive behavioral therapy (beta = -0.41; 95% CI, -0.64 to -0.17; P <001), and there were more treatment responders in cognitive behavioral therapy for both the Clinical Global Impression scale (53% vs 23%; odds ratio [OR], 3.80; 95% CI, 1.50 to 9.59; P = .01) and the ADHD rating scale (67% vs 33%; OR, 4.29; 95% CI, 1.74 to 10.58; P = .002). Responders and partial responders in the cognitive behavioral therapy condition maintained their gains over 6 and 12 months.Among adults with persistent ADHD symptoms treated with medication, the use of cognitive behavioral therapy compared with relaxation with educational support resulted in improved ADHD symptoms, which were maintained at 12 months.clinicaltrials.gov Identifier: NCT00118911.
| S-EPMC3641654 | biostudies-literature
Project description:Objective: This study evaluated the efficacy of an Integrated Brain, Body, and Social (IBBS) intervention for children with ADHD. Treatment consisted of computerized cognitive remediation training, physical exercises, and a behavior management strategy. Method: Ninety-two children aged 5 to 9 years with ADHD were randomly assigned to 15 weeks of IBBS or to treatment-as-usual. Primary outcome measures included blinded clinician ratings of ADHD symptoms and global clinical functioning. Secondary outcome measures consisted of parent and teacher ratings of ADHD and neurocognitive tests. Results: No significant treatment effects were found on any of our primary outcome measures. In terms of secondary outcome measures, the IBBS group showed significant improvement on a verbal working memory task; however, this result did not survive correction for multiple group comparisons. Conclusion: These results suggest that expanding cognitive training to multiple domains by means of two training modalities does not lead to generalized improvement of ADHD symptomatology.
| S-EPMC5107355 | biostudies-literature
Project description:Children with attention-deficit/hyperactivity disorder (ADHD) are at increased risk for developing depression. The neurobiological substrates that convey this risk remain poorly understood. On the basis of considerable data implicating hippocampal abnormalities in depressive disorders, we aimed to explore the relationship between the hippocampus and levels of depressive symptomatology in ADHD. We used magnetic resonance imaging (MRI) to examine the volumes and resting-state functional connectivity of the hippocampus in a sample of 32 medication naive children with ADHD (ages 6 - 13) and 33 age- and sex-matched healthy control (HC) participants. Compared with the HC participants, the participants with ADHD had (i) reduced volumes of the left hippocampus and (ii) reduced functional connectivity between the left hippocampus and the left orbitofrontal cortex (OFC); these hippocampal effects were associated with more severe depressive symptoms, even after controlling for the severity of inattentive and hyperactive/impulsive symptoms. Altered hippocampal structure and connectivity were not associated with anxiety or more general internalizing symptoms. Though preliminary, these findings suggest that the relationship between hippocampal anomalies and ADHD youth's susceptibility to developing depression and other mood disorders may merit further investigation with follow-up longitudinal research.
| S-EPMC4195849 | biostudies-literature
Project description:BackgroundDespite excessive consumption of sugar-sweetened beverages (SSB), little is known about behavioral interventions to reduce SSB intake among adults, particularly in medically-underserved rural communities. This type 1 effectiveness-implementation hybrid RCT, conducted in 2012-2014, applied the RE-AIM framework and was designed to assess the effectiveness of a behavioral intervention targeting SSB consumption (SIPsmartER) when compared to an intervention targeting physical activity (MoveMore) and to determine if health literacy influenced retention, engagement or outcomes.MethodsGuided by the Theory of Planned Behavior and health literacy strategies, the 6 month multi-component intervention for both conditions included three small-group classes, one live teach-back call, and 11 interactive voice response calls. Validated measures were used to assess SSB consumption (primary outcome) and all secondary outcomes including physical activity behaviors, theory-based constructs, quality of life, media literacy, anthropometric, and biological outcomes.ResultsTargeting a medically-underserved rural region in southwest Virginia, 1056 adult participants were screened, 620 (59%) eligible, 301 (49%) enrolled and randomized, and 296 included in these 2015 analyses. Participants were 93% Caucasian, 81% female, 31 % ≤ high-school educated, 43% < $14,999 household income, and 33% low health literate. Retention rates (74%) and program engagement was not statistically different between conditions. Compared to MoveMore, SIPsmartER participants significantly decreased SSB kcals and BMI at 6 months. SIPsmartER participants significantly decreased SSB intake by 227 (95% CI = -326,-127, p < 0.001) kcals/day from baseline to 6 months when compared to the decrease of 53 (95% CI = -88,-17, p < 0.01) kcals/day among MoveMore participants (p < 0.001). SIPsmartER participants decreased BMI by 0.21 (95% CI = -0.35,-0.06; p < 0.01) kg/m(2) from baseline to 6 months when compared to the non-significant 0.10 (95 % CI = -0.23, 0.43; NS) kg/m(2) gain among MoveMore participants (p < 0.05). Significant 0-6 month effects were observed for about half of the theory-based constructs, but for no biological outcomes. Health literacy status did not influence retention rates, engagement or outcomes.ConclusionsSIPsmartER is an effective intervention to decrease SSB consumption among adults and is promising for translation into practice settings. SIPsmartER also yielded small, yet significant, improvements in BMI. By using health literacy-focused strategies, the intervention was robust in achieving reductions for participants of varying health literacy status.Trial registrationClinicaltrials.gov; ID: NCT02193009 .
| S-EPMC4802861 | biostudies-literature
Project description:BackgroundEducational interventions can reduce potentially inappropriate medication (PIM) use in older people. Their effectiveness has been measured mainly as changes in PIM use. In this economic evaluation, we analyse the impact of an educational intervention in terms of costs and quality-adjusted life years (QALYs).MethodsThe educational intervention consisted of activating and interactive training sessions for nursing staff and consulting physicians, and was compared with treatment as usual (TAU). Participants (n = 227) in a cluster randomised trial (cRCT) were residents living permanently in assisted living facilities (n = 20 wards). For economic evaluation, participants' healthcare service use costs and costs for the intervention were estimated for a 12 month period.Incremental cost-effectiveness ratios (ICERs) were estimated for QALYs per participant. Cost-effectiveness analysis was conducted from a healthcare perspective. A bootstrapped cost-effectiveness plane and one-way sensitivity analysis were undertaken to analyse the uncertainty surrounding the estimates.ResultsThe educational intervention was estimated to be less costly and less effective in terms of QALYs than TAU at the 12 month follow-up [incremental costs -€1,629, confidence interval (CI) -€5,489 to €2,240; incremental effect -0.02, CI -0.06 to 0.02]. The base case ICER was >€80,000/QALY.ConclusionThe educational intervention was estimated to be less costly and less effective in terms of QALYs compared with TAU, but the results are subject to some uncertainties. Reduction in PIM use or benefits in quality of life did not seem to translate into improvements in QALYs. Our findings emphasise the need for better understanding of the impact of decreasing PIM use on health outcomes.
| S-EPMC9126199 | biostudies-literature
Project description:ObjectiveTo determine whether children born to women who use antiseizure medications (ASMs) during pregnancy have higher risk of autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) independent of confounding factors.MethodsWe used Swedish register data (n = 14,614 children born 1996-2011 and followed up through 2013) to examine associations in children of women with epilepsy, using the largest sample to date and adjusting for a range of measured confounders. We examined maternal-reported first-trimester use of any ASM (22.7%) and the 3 most commonly reported individual drugs (valproic acid 4.8%, lamotrigine 6.8%, and carbamazepine 9.7%). We identified ASD with ICD-10 diagnoses and ADHD with ICD-10 diagnoses or filled prescriptions of ADHD medication.ResultsExamination of individual drugs revealed that after adjustment for confounding, use of valproic acid was associated with ASD (hazard ratio [HR] 2.30, 95% confidence interval [CI] 1.53-3.47) and ADHD (HR 1.74, 95% CI 1.28-2.38). Whereas a small, nonstatistically significant association with ASD (HR 1.25, 95% CI = 0.88-1.79) and ADHD (HR 1.18, 95% CI 0.91-1.52) remained for reported use of carbamazepine, confounding explained all of the associations with lamotrigine (HRASD 0.86, 95% CI 0.67-1.53; HRADHD 1.01, 95% CI 0.67-1.53).ConclusionsWe found no evidence of risk related to exposure to lamotrigine, whereas we observed elevated risk of ASD and ADHD related to maternal use of valproic acid. Associations with carbamazepine were weak and not statistically significant. Our findings add to a growing body of evidence that suggests that certain ASMs may be safer than others in pregnancy.
| S-EPMC7836668 | biostudies-literature
Project description:Many students with reading difficulties and disabilities (RD) also have Attention Deficit/Hyperactivity Disorder (ADHD). This randomized clinical trial compared the effects of ADHD treatment alone (medication, parent training), intensive reading intervention alone, and their combination on the reading fluency and comprehension of students with both disorders. Students with ADHD and RD were randomly assigned to receive (a) Reading Intervention only (n=74), (b) ADHD Treatment only (n=78), or (c) simultaneous Combined ADHD and RD Treatment (n=70). For phonemic decoding fluency, the Reading Intervention group and the Combined Treatment group both had significantly better outcomes than the ADHD Treatment group, but did not differ from one another. For passage comprehension, the ADHD Treatment group had significantly better outcomes than the Reading Intervention group, while the other groups did not differ from one another. ADHD treatment may support passage comprehension in this population, while fluent decoding is best supported through intensive reading intervention.
| S-EPMC7518569 | biostudies-literature