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Correlations Between Clinical Trial Outcomes Based on Symptoms, Functional Impairments, and Quality of Life in Children and Adolescents With ADHD.

ABSTRACT: OBJECTIVE:To assess relationships between treatment-associated changes in measures of ADHD symptoms, functional impairments, and health-related quality of life in children and adolescents with ADHD. METHOD:Pearson correlation coefficients were calculated post hoc for changes from baseline to endpoint in outcomes of one randomized, placebo- and active-controlled trial of lisdexamfetamine (osmotic-release methylphenidate reference) and one of guanfacine extended-release (atomoxetine reference). RESULTS:Changes in ADHD Rating Scale IV (ADHD-RS-IV) total score generally correlated moderately with changes in Child Health and Illness Profile-Child Edition: Parent Report Form (CHIP-CE:PRF) Achievement and Risk Avoidance ( r ? .4), but weakly with Resilience, Satisfaction, and Comfort ( r ? .2); and moderately with Weiss Functional Impairment Rating Scale-Parent (WFIRS-P) total score ( r ? .5). CHIP-CE:PRF Achievement and Risk Avoidance correlated moderately to strongly with WFIRS-P total score ( r ? .6). CONCLUSION:The ADHD-RS-IV, CHIP-CE:PRF, and WFIRS-P capture distinct but interconnected aspects of treatment response in individuals with ADHD.

SUBMITTER: Coghill DR

PROVIDER: S-EPMC6732817 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Correlations Between Clinical Trial Outcomes Based on Symptoms, Functional Impairments, and Quality of Life in Children and Adolescents With ADHD.

Coghill David R DR Joseph Alain A Sikirica Vanja V Kosinski Mark M Bliss Caleb C Huss Michael M

Journal of attention disorders 20170824 13

<h4>Objective</h4>To assess relationships between treatment-associated changes in measures of ADHD symptoms, functional impairments, and health-related quality of life in children and adolescents with ADHD.<h4>Method</h4>Pearson correlation coefficients were calculated post hoc for changes from baseline to endpoint in outcomes of one randomized, placebo- and active-controlled trial of lisdexamfetamine (osmotic-release methylphenidate reference) and one of guanfacine extended-release (atomoxetine ...[more]

PMID: 28836895

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Project description:BackgroundOptimal management of attention deficit hyperactivity disorder (ADHD) aims not only to ameliorate patients' symptoms, but also to improve health-related quality of life (HRQL) and functioning. A pivotal, 7-week, randomized, double-blind, placebo-controlled, phase III study in children and adolescents in ten European countries demonstrated that the stimulant prodrug lisdexamfetamine dimesylate (LDX) is an effective and generally well-tolerated treatment for symptoms of ADHD.ObjectiveThe aim of this study was to assess HRQL and functional impairment outcomes in this clinical trial, using the Child Health and Illness Profile-Child Edition: Parent Report Form (CHIP-CE:PRF) and the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P), respectively.MethodsPatients (aged 6-17 years) with diagnosed ADHD and a baseline ADHD Rating Scale IV total score ≥28 were randomized (1:1:1) to 7 weeks of double-blind treatment with once-daily LDX, placebo or the reference treatment, osmotic-release oral system methylphenidate (OROS-MPH). Participants' parents (or legally authorized representatives) completed the CHIP-CE:PRF and WFIRS-P questionnaires at baseline, at weeks 4 and 7, and/or at early termination. Endpoint was defined as the last on-treatment visit with valid data (≤30 % missing items). The CHIP-CE:PRF Achievement domain was pre-specified as the primary HRQL outcome.ResultsThe full analysis set comprised 317 patients (LDX, n = 104; placebo, n = 106; OROS-MPH, n = 107), the majority of whom completed the study (LDX, n = 77; placebo, n = 42; OROS-MPH, n = 72). Baseline CHIP-CE:PRF T-scores in four of the five domains were ≥1 standard deviation below norms (US community samples). Compared with placebo, LDX was associated with statistically significantly improved T-scores from baseline to endpoint in these four domains, with effect sizes of 1.280 (p < 0.001) in Achievement, 1.079 (p < 0.001) in Risk Avoidance, 0.421 (p < 0.01) in Resilience and 0.365 (p < 0.05) in Satisfaction. In LDX-treated patients, placebo-adjusted improvements from baseline to endpoint in WFIRS-P scores were statistically significant (p < 0.001) for total score and four of the six domains, with effect sizes of 0.924 (total score), 1.249 (Learning and School), 0.730 (Family), 0.643 (Social Activities) and 0.640 (Risky Activities). OROS-MPH treatment showed similar patterns of improvement from baseline to endpoint in both CHIP-CE:PRF and WFIRS-P scores.ConclusionsBaseline HRQL and functional impairment scores reflect the burden of untreated ADHD. The benefits of short-term stimulant treatment in children and adolescents with ADHD extend beyond symptomatic relief and impact positively on HRQL and daily functioning.

Project description:PurposeThe ADHD Rating Scale (ADHD-RS) assesses 18 symptoms of inattention and hyperactivity/impulsivity and has been used in many clinical trials to evaluate the treatment effect of drugs on ADHD. The fifth edition of this scale (ADHD-RS-5) also assesses the impact of inattention and hyperactivity/impulsivity symptoms on six domains of functional impairment (FI): family relationships, peer relationships, completing/returning homework, academic performance at school, controlling behavior at school, and self-esteem. Here, we report the effect of viloxazine extended-release capsules (viloxazine ER), a novel nonstimulant treatment for ADHD in children and adolescents (ages 6-17 years), on FI from a post hoc analysis of four randomized, double-blind, placebo-controlled Phase 3 clinical trials (N=1354).Patients and methodsADHD-RS-5 investigator ratings of ADHD symptoms and FIs were conducted at baseline and weekly post-baseline for 6-8 weeks in the four trials. Change from baseline (CFB) in ADHD-RS-5 FI scores (Total score [sum of 12 FI items] and Inattention and Hyperactivity/Impulsivity subscale scores [sum of 6 corresponding FI items]) and the 30% and 50% Responder Rates (ADHD-RS-5 FI Total score) were compared between viloxazine ER and placebo.ResultsThe reduction (improvement) in ADHD-RS-5 FI scores (Total and subscale scores) and the percentage of responders (30% and 50%) at Week 6 were significantly greater in each viloxazine ER dose group vs placebo. In the 100-400 mg/day viloxazine ER groups, improvements were found as early as Week 1 (100-mg/day) or Week 2 (200-, 400-mg/day) of treatment. Analysis of individual items of ADHD-related FIs demonstrated that the effect of viloxazine ER was observed across all domains of impairment.ConclusionSignificant improvements observed in ADHD-related FIs are consistent with the reduction in inattention and hyperactivity/impulsivity symptoms demonstrated in the viloxazine ER Phase 3 pediatric trials. Therefore, viloxazine ER provides clinically meaningful improvement of ADHD symptoms and functioning in children and adolescents with ADHD, starting as early as Week 1-2 of treatment.

Project description:BackgroundCognitive behavioural therapy (CBT) is recommended for attention-deficit/hyperactivity-disorder (ADHD) in adolescents. However, all CBTs are not created equal, and the guidelines do not specify which CBT interventions are the most effective for this patient group. This study examines the efficacy of a group CBT without parent involvement as follow-up treatment compared to no additional CBT in adolescents with persistent and impairing ADHD symptoms after a short psychoeducational intervention and medical treatment.MethodsThe authors conducted a two-arm parallel randomized controlled trial in two child and adolescent mental health outpatient clinics in Norway. One hundred patients aged 14-18 years with a diagnosis of ADHD (66%) or subthreshold ADHD (34%) were randomized to either a 12-week group CBT program (N = 50) or a non-CBT control condition (N = 50). Assessments were made at admission to the clinic, two weeks before and two weeks after treatment. The primary outcomes were parent-, teacher- and self-ratings of ADHD symptoms (ADHD Rating Scale-IV), and the secondary outcomes were ratings of ADHD symptom severity, executive function, functional impairment, and emotional problems. Evaluators blinded to group allocation rated ADHD symptom severity with the Clinical Global Impression Scale for Severity (CGI-S) at baseline and post-treatment.ResultsAnalyses using mixed-effects models showed no difference between the treatment arms from baseline to post treatment in primary and secondary outcomes.ConclusionsContrary to our hypothesis, we found no incremental treatment effect on the part of a group CBT as follow-up to psychoeducation and pharmacological treatment on ADHD symptoms and accompanying impairments. Limitations with the CBT was the large number and low dosage of treatment components, causing restricted time for practice. Unlike evidence-based, individualized targeted CBTs with parent involvement, a group CBT directed solely at the adolescents with no parent involvement does not appear effective for treating ADHD.Trial registrationNCT02937142 , 18/10/2016.

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Correlations Between Clinical Trial Outcomes Based on Symptoms, Functional Impairments, and Quality of Life in Children and Adolescents With ADHD.

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Correlations Between Clinical Trial Outcomes Based on Symptoms, Functional Impairments, and Quality of Life in Children and Adolescents With ADHD.

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