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Randomized Trial of First-Line Behavioral Intervention to Reduce Need for Medication in Children with ADHD.

ABSTRACT: A study conducted in an analogue summer treatment setting showed that when concurrently receiving behavioral intervention, many children with Attention-Deficit Hyperactivity Disorder (ADHD) did not need medication or maximized responsiveness at very low doses. The present study followed participants in that summer study into the subsequent school year to investigate whether the same pattern would extend to the natural school and home settings. There were 127 unmedicated children with ADHD between the ages of 5 and 13 who were randomly assigned to receive or not receive behavioral consultation (BC) at the start of the school year. Children were evaluated by teachers and parents each week to determine if central nervous system stimulant treatment was needed. Children who received BC were approximately half as likely those who did not (NoBC) to initiate medication use each week at school or home and used lower doses when medicated at school. This produced a 40% reduction in total methylphenidate exposure over the course of the school year. BC and NoBC groups did not significantly differ on end-of-year teacher or parent ratings of behavior, which were positive. Moreover, BC and NoBC groups did not significantly differ in cost of treatment; although children in the BC condition accrued additional costs via the BC, these costs were offset by the associated delay and reduction in medication use. Results add to a growing literature suggesting that the use of low-intensity behavioral intervention as a first-line treatment reduces or eliminates the need for medication in children with ADHD.

SUBMITTER: Coles EK

PROVIDER: S-EPMC7018583 | biostudies-literature | 2020 Sep-Oct

REPOSITORIES: biostudies-literature

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Randomized Trial of First-Line Behavioral Intervention to Reduce Need for Medication in Children with ADHD.

Coles Erika K EK Pelham William E WE Fabiano Gregory A GA Gnagy Elizabeth M EM Burrows-MacLean Lisa L Wymbs Brian T BT Chacko Anil A Walker Kathryn S KS Wymbs Frances F Robb Mazzant Jessica J Garefino Allison A Hoffman Martin T MT Massetti Greta M GM Page Timothy F TF Waschbusch Daniel A DA Waxmonsky James G JG Pelham William E WE

Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53 20190814 5

A study conducted in an analogue summer treatment setting showed that when concurrently receiving behavioral intervention, many children with Attention-Deficit Hyperactivity Disorder (ADHD) did not need medication or maximized responsiveness at very low doses. The present study followed participants in that summer study into the subsequent school year to investigate whether the same pattern would extend to the natural school and home settings. There were 127 unmedicated children with ADHD betwee ...[more]

PMID: 31411903

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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).

Project description:ContextAttention-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.ObjectiveTo test cognitive behavioral therapy for ADHD in adults treated with medication but who still have clinically significant symptoms.Design, setting, and patientsRandomized 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.InterventionsPatients were randomized to 12 individual sessions of either cognitive behavioral therapy or relaxation with educational support (which is an attention-matched comparison).Main outcome measuresThe 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.ResultsCognitive 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.ConclusionAmong 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.Trial registrationclinicaltrials.gov Identifier: NCT00118911.

Project description:ImportanceInadequate communication between caregivers and clinicians at hospital discharge contributes to medication dosing errors in children. Health literacy-informed communication strategies during medication counseling can reduce dosing errors but have not been tested in the pediatric hospital setting.ObjectiveTo test a health literacy-informed communication intervention to decrease liquid medication dosing errors compared with standard counseling in hospitalized children.Design, setting, and participantsThis parallel, randomized clinical trial was performed from June 22, 2021, to August 20, 2022, at a tertiary care, US children's hospital. English- and Spanish-speaking caregivers of hospitalized children 6 years or younger prescribed a new, scheduled liquid medication at discharge were included in the analysis.InterventionsPermuted block (n = 4) randomization (1:1) to a health literacy-informed discharge medication communication bundle (n = 99) compared with standard counseling (n = 99). A study team member delivered the intervention consisting of a written, pictogram-based medication instruction sheet, teach back (caregivers state information taught), and demonstration of dosing with show back (caregivers show how they would draw the liquid medication in the syringe).Main outcome and measuresObserved dosing errors, assessed using a caregiver-submitted photograph of their child's medication-filled syringe and expressed as the percentage difference from the prescribed dose. Secondary outcomes included caregiver-reported medication knowledge. Outcome measurements were blinded to participant group assignment.ResultsAmong 198 caregivers randomized (mean [SD] age, 31.4 [6.5] years; 186 women [93.9%]; 36 [18.2%] Hispanic or Latino and 158 [79.8%] White), the primary outcome was available for 151 (76.3%). The observed mean (SD) percentage dosing error was 1.0% (2.2 percentage points) among the intervention group and 3.3% (5.1 percentage points) among the standard counseling group (absolute difference, 2.3 [95% CI, 1.0-3.6] percentage points; P < .001). Twenty-four of 79 caregivers in the intervention group (30.4%) measured an incorrect dose compared with 39 of 72 (54.2%) in the standard counseling group (P = .003). The intervention enhanced caregiver-reported medication knowledge compared with the standard counseling group for medication dose (71 of 76 [93.4%] vs 55 of 69 [79.7%]; P = .03), duration of administration (65 of 76 [85.5%] vs 49 of 69 [71.0%]; P = .04), and correct reporting of 2 or more medication adverse effects (60 of 76 [78.9%] vs 13 of 69 [18.8%]; P < .001). There were no differences in knowledge of medication name, indication, frequency, or storage.Conclusions and relevanceA health literacy-informed discharge medication communication bundle reduced home liquid medication administration errors and enhanced caregiver medication knowledge compared with standard counseling. Routine use of these standardized strategies can promote patient safety following hospital discharge.Trial registrationClinicalTrials.gov Identifier: NCT05143047.

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 .

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Randomized Trial of First-Line Behavioral Intervention to Reduce Need for Medication in Children with ADHD.

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Randomized Trial of First-Line Behavioral Intervention to Reduce Need for Medication in Children with ADHD.

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