Weiss Functional Impairment Rating Scale Research Articles

Longitudinal Predictors of Adaptive Functioning in Emerging Adults with and without Autism Spectrum Disorder.

Individuals with autism spectrum disorder (ASD) display heterogeneity in adaptive functioning, underscoring the need to identify predictors to inform clinical and scientific interventions. We investigated the longitudinal associations between an autism diagnosis, co-occurring psychopathology symptoms, executive functions (EF) and subsequent adaptive functioning in individuals with and without ASD (IQ > 70). Sixty-six individuals (26 with ASD, 40 without ASD) were assessed at baseline (mean age = 11.8 years, SD = 2.1) and at 10-year follow-up (mean age 21.4, SD = 2.3). The diagnostic evaluation comprised a comprehensive assessment of autism symptoms and emotional and cognitive functioning. Co-occurring psychopathology symptoms were assessed with two measures: self-reported depressive symptoms with the Short Mood and Feelings Questionnaire and parent-reported total problems with the Child Behavior Checklist 6-18. Participants completed neuropsychological tests to evaluate EF. We investigated adaptive functioning by using the Weiss Functional Impairment Rating Scale (WFIRS) which is a self-report measure of impairment in the following domains: family, work, school, life skills, self-concept, social and risk-taking. Among the emerging adults previously diagnosed with ASD, 46% reported living independently, 75% had at least one friend, and 71% were employed or in education. Individuals with ASD reported significantly lower adaptive functioning compared to individuals without ASD (WFIRS Total, Hedges' g = 0.92). Greater EF difficulties in childhood/adolescence predicted lower adaptive functioning in emerging adulthood, surpassing the influence of autism diagnosis and co-occurring symptoms. The findings highlight the influential role of EF, implying that interventions targeting EF difficulties could improve long-term outcomes for individuals with ASD.

Safety and effectiveness of methylphenidate ER multi-unit pellet system in ADHD patients: An open label study.

Attention deficit hyperactive disorder (ADHD) is a neurodevelopmental disorder occurring in children and adults. Pharmacotherapy remains the cornerstone of ADHD treatment. Stimulants such as methylphenidate are effective and have been one of the best studied and most frequently used treatment for ADHD. However, different delivery mechanisms and devices may potentially impact patient experience and real-life outcomes. This study evaluated the effectiveness of Multiple-Unit Pellet System Delivered Extended-Release Methylphenidate (Contramyl XR) on symptom control and reported outcomes in ADHD patients, in a real-world setting. A phase IV, open label, flexible dose, prospective, observational study conducted at six sites covering five provinces of South Africa. About 119 participants with ADHD (both newly diagnosed [treatment-naïve] and methylphenidate-treated [switch-over] patients) were enrolled and initiated either on Contramyl XR or switched over from methylphenidate to Contramyl XR. Primary efficacy was assessed by Weiss Functional Impairment Rating Scale (WFIRS) over 12 weeks. In all, 117 participants completed the study (treatment-naïve patients: 46% [n = 55] and switch-over patients: 54% [n = 64]). Mean change from baseline in total WFIRS (95% confidence interval) was -17.7 (-21.1, -14.3; p < 0.001) at week 4 and -29.3 (-33.5, -25.2; p < 0.001) at week 12. At week 12, there was significant improvement in WFIRS scores, with treatment satisfaction reported by treatment-naïve patients. Switch-over patients also demonstrated comparable effectiveness. Contramyl XR was found to be clinically effective either as de novo or as switch therapy. It was well tolerated, and all patients chose to continue with the treatment option. Despite distinct and different delivery mechanism of Contramyl XR, this study provides evidence for using it as an alternate treatment option versus reference methylphenidate, in both treatment-naïve and switch-over ADHD patients. Study participants willingness to continue Contramyl XR therapy post study, further strengthens the confidence on the effectiveness of Contramyl XR in managing ADHD patients.

Measuring clinical outcomes in adult ADHD clinics: psychometrics of a new scale, the adult ADHD Clinical Outcome Scale.

Adult attention-deficit hyperactivity disorder (ADHD) clinics are in their infancy in Ireland and internationally. There is an urgent need for clinical evaluation of these services. Until now, clinical outcomes have relied mainly on functional scales and/or quality of life. However, adult ADHD is a longstanding disorder with many comorbidities. Although medication for ADHD symptoms can have immediate effects, co-occurring problems may take considerably longer to remediate. To present the psychometrics of a short outcome measure of key clinical areas including symptoms. The ADHD Clinical Outcome Scale (ACOS), developed by the authors, is a clinician-rated scale and was administered in consecutive adults attending an ADHD clinic. A modified version was completed by the participant. A second clinician independently administered the scale in a subsample. ACOS consists of 15 items rated on a Likert scale. Two self-report scales, the Adult ADHD Quality of Life Questionnaire (AAQoL) and Weiss Functional Impairment Rating Scale (WFIRS), were also administered. The mean age of 148 participants was 30.1 years (s.d. = 9.71), and 81 were female (54.7%). The correlation for interrater reliability was r = 0.868, and that between the participant and clinician versions was r = 0.663. The intraclass correlation coefficient for the internal consistency was 0.829, and the correlations for concurrent validity with total AAQoL and WFIRS scores were r = -0.573 and r = 0.477, respectively. Factor analysis revealed four factors: (a) attentional/organisational problems; (b) hyperactivity/impulsivity; (c) comorbidities; and (d) alcohol/drug use, self-harm and tension in relationships. The psychometrics of the ACOS are promising, and the inclusion of typically co-occurring clinical domains makes it suitable for use as a clinician-rated outcome measure in every contact with patients attending adult ADHD clinics.

Functional impairment and quality of life in newly diagnosed adults attending a tertiary ADHD clinic in Ireland.

Attention Deficit-Hyperactive Disorder (ADHD) is a neurodevelopmental disorder, often persisting into adulthood. To investigate the levels of functionality and quality of life (QoL) in adult patients newly diagnosed with ADHD and to compare with those without an ADHD diagnosis. Consecutive patients who were referred to and assessed in a tertiary adult ADHD clinic enrolled in the study. Diagnosis of ADHD was based on DSM-5 criteria. Functionality was measured using the Weiss Functional Impairment Rating Scale (WFIRS) and the Global Assessment of Functioning Scale (GAF). QoL was assessed with the Adult ADHD Quality of Life Questionnaire (AAQoL). Three-hundred and forty participants were recruited, 177 (52.1%) females. Of them 293 (86.2%) were newly diagnosed with ADHD. Those with ADHD had significant lower functionality as it was measured with the WFIRS and GAF, and worse QoL (AAQoL) compared to those without. In addition, a significant correlation between GAF and WFIRS was found. The results show that adults with ADHD have decreased functionality and worse QoL when compared against those presenting with a similar symptomatology, but no ADHD diagnosis. ADHD is not just a behavioural disorder in childhood, but a lifelong condition with accumulating problems that can lead to lower QoL and impaired functioning throughout adulthood.

Emotion Regulation Mediates Functional Impairment in Thai Children with Attention-deficit/ hyperactivity Disorder: A Cross-Sectional Study

Objective: The study investigated the potential mediating effects of emotion regulation and emotion lability/negativity in the relationship between attention-deficit/hyperactivity disorder (ADHD) symptoms and functional impairment while also examining the associations between ADHD symptoms, emotion regulation, and impaired functioning in different life domains among children with ADHD. Materials and Methods: The clinical sample comprised 118 children diagnosed with ADHD aged 6–12 years. Primary caregivers completed parent reports on symptom severity using the Thai ADHD Screening Scale–Parent Version, assessed emotion regulation and lability/ negativity via the Emotion Regulation Checklist, and evaluated functional impairment using the Weiss Functional Impairment Rating Scale–Parent Version. Results: ADHD symptoms correlated negatively with overall emotion regulation (r = −0.515, p &lt; 0.01) and positively with lability/negativity (r = 0.583, p &lt; 0.01). Functional impairment exhibited a negative correlation with emotion regulation (r = −0.649, p &lt; 0.01) and a positive correlation with lability/negativity (r = 0.701, p &lt; 0.01). Elevated ADHD symptoms were linked with increased functional impairment (r = 0.639, p &lt; 0.01). The parallel mediational model showed that emotion lability/negativity partially mediated the association between ADHD symptoms and functional impairment (β = 0.282, p &lt; 0.001), suggesting that ADHD symptoms and emotion lability/negativity indirectly accentuate functional impairment. Thus, heightened ADHD symptoms may exacerbate emotion lability/negativity, contributing to increased functional impairments. Conclusion: Emotion regulation difficulties, particularly emotion lability/negativity, may serve as significant risk factors. Regular monitoring and targeting these challenges hold promise in alleviating adverse functional outcomes co-occurring with elevated ADHD symptoms.

Evaluation of p300 and spectral resolution in children with attention deficit hyperactivity disorder and specific learning disorder.

This study aims to examine auditory processing, P300 values and functional impairment levels among children with Attention Deficit and Hyperactivity Disorder (ADHD), Specific Learning Disorder (SLD), ADHD+SLD and healthy controls. Children with ADHD (n=17), SLD (n=15), ADHD+SLD (n=15), and healthy controls (n=15) between the ages of 7-12 were evaluated with K-SADS, Weiss Functional Impairment Rating Scale, Turgay DSM-IV Disruptive Behavior Disorders Rating Scale, The Mathematics, Reading, Writing Assessment Scale and Children's Auditory Performance Scale (CHAPS). Auditory P300 event-related potentials and Spectral-Temporally Modulated Ripple Test (SMRT) were applied. Three patient groups were found to be riskier than healthy controls according to the CHAPS. There was no significant difference between the groups in the SMRT. In post-hoc analyses of P300 parietal amplitudes, ADHD, SLD, and ADHD+SLD were found to be significantly lower than the control group. The amplitudes of the ADHD+SLD were by far the lowest. It has been shown that auditory performance skills and p300 amplitudes are lower in children diagnosed with only ADHD or SLD compared to the control group, with the lowest values observed in ADHD+SLD. This study suggests that the difficulties with attention and cognitive functions in the ADHD+SLD are more severe than ADHD and/or SLD without comorbidity.

Effect of non-pharmacological treatment on the full recovery of social functioning in patients with attention deficit hyperactivity disorder

Long-term treatment of attention deficit/hyperactivity disorder (ADHD) is associated with adverse events, such as nausea and vomiting, dizziness, and sleep disturbances, and poor maintenance of late ADHD medication compromises treatment outcomes and prolongs the recovery of patients' social functioning. To evaluate the effect of non-pharmacological treatment on the full recovery of social functioning in patients with ADHD. A total of 90 patients diagnosed with ADHD between May 2019 and August 2020 were included in the study and randomly assigned to either the pharmacological group (methylphenidate hydrochloride and tomoxetine hydrochloride) or the non-pharmacological group (parental training, behavior modification, sensory integration therapy, and sand tray therapy), with 45 cases in each group. Outcome measures included treatment compliance, Swanson, Nolan, and Pelham, Version IV (SNAP-IV) scores, Conners Parent Symptom Questionnaire (PSQ) scores, and Weiss Functional Impairment Rating Scale (WFIRS) scores. The non-pharmacological interventions resulted in significantly higher compliance in patients (95.56%) compared with medication (71.11%) (P < 0.05). However, no significant differences in SNAP-IV and PSQ scores, in addition to the learning/school, social activities, and adventure activities of the WFIRS scores were observed between the two groups (P > 0.05). Patients with non-pharmacological interventions showed higher WFIRS scores for family, daily life skills, and self-concept than those in the pharmacological group (P < 0.05). Non-pharmacological interventions, in contrast to the potential risks of adverse events after long-term medication, improve patient treatment compliance, alleviate patients' behavioral symptoms of attention, impulsivity, and hyperactivity, and improve their cognitive ability, thereby improving family relationships and patient self-evaluation.

Validation of the Weiss Functional Impairment Rating Scale (WFIRS-P) as a Functional Impairment Measure in a General Population of Schoolchildren.

Functional impairment rating scales are few in numbers and have mainly been examined in clinical populations. The Weiss Functional Impairment Rating Scale-Parent report (WFIRS-P) is a case in point. We tested the psychometric properties of the WFIRS-P in the largest general population study to date and for the first time examined the factor structure of the scale in a general population setting. Participants were 2,027 schoolchildren aged 6 to 11. Parents/caregivers completed the WFIRS-P and criterion measures of quality of life, attention-deficit/hyperactivity disorder, and behavioral/emotional symptoms. Confirmatory factor analysis and convergent/divergent validity analyses supported a six-factor structure: family, life skills, self-concept, social activities, and the separation of the school domain into two smaller domains covering school learning and school behavior. Children with and without a history of referral differed significantly on all six domains supporting the external validity. In conclusion, the WFIRS-P was found to generate valid scores in a general population sample.

TREATING OBSESSIVE COMPULSIVE DISORDER WITH ACCEPTANCE AND COMMITMENT THERAPY AND EXPOSURE AND RESPONSE PREVENTION– A CLINICAL CASE ILLUSTRATION

Obsessive Compulsive Disorder (OCD) is ranked the top 10 of the most handicapping illnesses by lost income and decreased quality of life. Hence the need to overcome OCD is imminent. With the present case of OCD, Acceptance and Commitment Therapy (ACT) and Exposure Prevention Response (ERP) were used for treating OCD. Assessment was done using Yale Brown Obsessive Compulsive Scale and Weiss Functional Impairment Rating Scale – Self report. Results show that OCD reduced signicantly after the treatment.

Effect of Past Pharmacotherapy for Attention-Deficit/Hyperactivity Disorder on Substance Use Disorder

Background: Substance use disorders (SUDs) are a considerable public health problem. Attention-deficit/hyperactivity disorder (ADHD) frequently occurs in patients with SUD. Several studies demonstrated that ADHD constitutes a significant risk factor for the development of SUDs and suggest that childhood ADHD pharmacotherapy might help prevent development of SUD. Objectives: The study aimed to explore the effect of childhood ADHD pharmacotherapy on later life’s functional impairment and substance use patterns. Methods: Treatment-seeking SUD patients with ADHD (n = 52) were recruited from various rehabilitation facilities in South Africa. Adult ADHD individuals without SUD (n = 48) were recruited from clinicians, retail pharmacies, and the general public. SUD participants in rehabilitation facilities were screened for and diagnosed with ADHD. Lifetime substance use was assessed using self-report. ADHD-related functional impairment was assessed by the Weiss Functional Impairment Rating Scale (WFIRS). Information on present and lifetime use of ADHD medication was obtained. Clinical outcomes between those with and without a history of ADHD pharmacotherapy were compared. Results: Medicated participants (n = 59) showed lower levels of ADHD-related impairment across all functional domains (p < 0.001), compared to non-medicated participants (n = 41). They also consumed less alcohol (p = 0.04), cannabis (p < 0.001), and illicit drugs (p = 0.006) compared to the non-medicated group. Furthermore, medicated participants had a lower frequency of tobacco use compared to non-medicated participants (p = 0.04). ADHD patients without SUD also more often received medication (100% vs. 18.6%; p < 0.001) and for a longer time (121.10 vs. 9.52 months; p < 0.001). Conclusion: Childhood ADHD pharmacotherapy might be associated with a decreased risk for substance use in adulthood and lower ADHD-related impairment. Despite study limitations, these findings underline the importance of early ADHD detection and treatment, which might prevent SUD.

Executive functions mediate the association between ADHD symptoms and anxiety in a clinical adolescent population.

ObjectiveAttention-deficit/hyperactivity disorder (ADHD) is associated with a high prevalence of anxiety disorders in children and adolescents. The reasons for this association are poorly understood. Preliminary findings with young adults have suggested that executive functions and functional impairment may mediate the relationship between symptoms of ADHD and mixed anxiety and depressive symptoms. The objective of this study was to explore whether ADHD symptoms, executive functions and functional impairment predict anxiety in a clinical adolescent population. In addition, we investigated the possible mediating role of executive functions and functional impairment in this relationship.MethodOne hundred adolescents with ADHD and their parents completed the ADHD Rating Scale IV (ADHD RS-IV), the Behavior Rating Inventory of Executive Function (BRIEF), and the Weiss Functional Impairment Rating Scale (WFIRS) in relation to an RCT study. The adolescents also completed the Screen for Child Anxiety-Related Emotional Disorders (SCARED). Analyses were conducted using regression and a serial multiple mediator model.ResultsIn the regression analyses, parent-rated ADHD symptoms were unable to predict anxiety, but ADHD inattention symptoms predicted anxiety in the self-ratings. Executive dysfunction and functional impairment predicted anxiety in both the parent- and self-reports. In the mediation analyses ADHD symptoms alone did not predict anxiety, but executive dysfunction mediated this relationship as expected. Functional impairment mediated this relationship indirectly through executive functions. The results were similar in the parent- and self- reports.ConclusionThe results pinpoint executive dysfunction as an important treatment target for alleviating anxiety in adolescents with impairing ADHD symptoms.

Quality of life, functional impairment and continuous performance task event-related potentials (ERPs) in young adults with ADHD and autism: A twin study.

Young adulthood is a key developmental period for understanding outcomes of childhood onset attention-deficit/hyperactivity disorder (ADHD) and autism. Measurement of functional impairment and quality of life (QoL) can provide important information on the real-life challenges associated with these conditions. Event-related potential (ERP) measures from the continuous performance task (CPT) have long been identified as altered in ADHD and autism but the role of these functions in the aetiological pathway to the disorders and associated impact on quality of life in young adulthood is unknown. We investigated the relationships between ADHD and autism, functional impairment, quality of life, and ERP measures from the cued CPT (CPT-OX) in a young adult twin sample (566 participants aged 22.43±0.96years old). We observed significant phenotypic correlations between ADHD/autism and lower quality of life with specific genetic overlap between ADHD and physical health, psychological, and environmental aspects. We found significant phenotypic and genetic correlations between ADHD and functional impairment in all domains, as well as between autism and impairment in social functioning and lower impairment in risk-taking. Both ADHD and autism were associated with attenuated amplitude of inhibitory and proactive control ERPs, with large genetic contributions to the overlap. We also found significant phenotypic correlations between these ERP measures and Weiss Functional Impairment Rating Scale (WFIRS) and QoL. This is the first study to investigate the phenotypic and genetic relationships between ADHD and autism, functional impairment, quality of life and ERP measures in young adulthood. Our findings could represent a step towards identifying ERP measures that are related to behaviour in the absence of overt symptoms.

How much impairment is required for ADHD? No evidence of a discrete threshold.

A diagnosis of attention-deficit/hyperactivity disorder (ADHD) requires the presence of impairment alongside symptoms above a specific frequency and severity threshold. However, the question of whether that symptom threshold represents anything more than an arbitrary cutoff on a continuum of impairment requires further empirical study. Therefore, we present the first study investigating if the relationship between ADHD symptom severity and functional impairment is nonlinear in a way that suggests a discrete, nonarbitrary symptom level threshold associated with a marked step increase in impairment. Parent reports on the ADHD-Rating Scale (ADHD-RS-IV), the Weiss Functional Impairment Rating Scale (WFIRS-P), and the Strengths and Difficulties Questionnaire were collected in a general population sample of 1st, 2nd, and 3rd graders (N = 1,914-2,044). Piecewise linear regression analyses and nonlinear regression modeling both demonstrated that the relationship between symptom severity (ADHD-RS-IV total score) and impairment (WFIRS-P mean score) was characterized by a gradual linear increase in impairment with higher symptom severity and no apparent step increase or changing rate of increase in impairment at a certain high ADHD-RS-IV total score level. Controlling for socioeconomic status, sex, and co-occurring conduct and emotional symptoms did not alter these results, though comorbid symptoms had a significant effect on impairment. There was no clear evidence for a discrete, nonarbitrary symptom severity threshold with regard to impairment. The results highlight the continued need to consider both symptoms and impairment in the diagnosis of ADHD.

Once-Daily SPN-812 200 and 400 mg in the treatment of ADHD in School-aged Children: A Phase III Randomized, Controlled Trial

PurposeSPN-812 (viloxazine extended-release) is under investigation for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. This Phase III study evaluated the efficacy and tolerability of SPN-812 200 and 400 mg once daily in children 6–11 years of age with ADHD. MethodsPatients were randomly assigned to receive SPN-812 200 mg, SPN-812 400 mg, or placebo, once daily for 8 weeks (including ≤3 weeks titration period). The primary efficacy endpoint was the change from baseline (CFB) in ADHD Rating Scale (RS)-5 Total score at end of study (EOS). Key secondary endpoints included Clinical Global Impression–Improvement (CGI-I) score at EOS, CFB in Conners 3–Parent Short Form (PS) composite T-score at EOS, and CFB in Weiss Functional Impairment Rating Scale–Parent (WFIRS-P) Total average score at EOS. FindingsA total of 313 patients were enrolled, with 301 in the intent-to-treat population (194 boys, 107 girls; mean age [SD], 8.4 [1.7] years). At EOS, the CFBs in ADHD-RS-5 Total score and CGI-I score were significantly improved with both 200- and 400-mg/d SPN-812 versus placebo (ADHD-RS-5, P = 0.0038 and 0.0063, respectively; CGI-I, P = 0.0028 and 0.0099). At EOS, the CFB in Conners 3-PS composite T-score was significantly improved with 200- (P = 0.0064), but not 400-mg/d (P = 0.0917), SPN-812 compared to placebo. No significant difference between the groups was found in WFIRS-P Total average score. The rate of discontinuations due to adverse events in both SPN-812 treatment groups combined was <5%. ImplicationsSPN-812 200 and 400 mg once daily was associated with improvements in ADHD symptoms in school-aged children and was generally well tolerated. ClinicalTrials.gov identifier: NCT03247543.

Public perceptions of adult ADHD: Indications of stigma?

Stigmatization represents a major barrier to treatment seeking across mental disorders. Despite this, stigma research on individual mental disorders remains in its infancy. Attention-deficit hyperactivity disorder (ADHD) in adults also represents an under-researched area—being far less studied than its child counterpart. This study examined the current state of public perceptions towards adult ADHD. A simulation group consisting of 105 participants performed the Weiss Functional Impairment Rating Scale (WFIRS) and Conners’ Adult ADHD Rating Scales (CAARS) as though they had ADHD. These scores were compared to a group consisting of 98 individuals with adult ADHD and a group of 117 healthy individuals both groups being instructed to complete the WFIRS and CAARS to the best of their abilities. Simulators were found to overestimate impairments in adult ADHD (to a large effect) in the domains of hyperactivity, DSM-IV hyperactivity-impulsivity, DSM-IV total, work, school, (to a medium effect) in family and social, and (to a negligible-small effect) in inattention, impulsivity, DSM-IV inattention, and life skills when compared to the ADHD group, and in all domains (to a large effect) when compared to the control group. Current and retrospective ADHD symptoms were found to be associated with more accurate perceptions in a number of domains. Evidence for the presence of perceptions considered to be stigmatizing was found, with largest effects present in the domains of hyperactivity, impulsivity, impairments at work, school, and engagement in risky behaviour.

Susceptibility of functional impairment ratings to noncredible reporting in postsecondary students undergoing screening for ADHD

Objective: Clinical evaluation for attention-deficit/hyperactivity disorder (ADHD) not only requires assessment of symptoms, but also consideration of the degree to which symptoms lead to impairment within various functional domains. However, ADHD evaluations in adulthood often rely on self-reported functional impairment, which might be vulnerable to malingering/noncredible responding. The present study utilized a clinical sample/known groups design to examine the relationship of noncredible presentation to functional impairment ratings by analyzing differential associations with both symptom and performance validity tests (SVTs and PVTs). Method: Participants were 168 postsecondary students who completed psychoeducational assessments for ADHD to determine their eligibility for academic accommodations and/or medications. Impairment ratings on the Weiss Functional Impairment Rating Scale (WFIRS) of 71 students who presented in a noncredible fashion were compared to 72 students who appeared to present credibly (controls) and 25 students diagnosed with ADHD who appeared to present credibly (clinical controls). Results: Relative to both control groups, individuals who presented noncredibly reported higher levels of disability on most functional domains and a higher percentage provided responses that fell in the impaired range on all functional domains of the WFIRS. Conclusions: Findings provide additional evidence that ADHD-related functional impairment ratings are susceptible to noncredible presentation and highlight the need for assessors to include both SVTs and PVTs in ADHD evaluations.

Psychometric properties of the Weiss Functional Impairment Rating Scale parent and self-reports in a Norwegian clinical sample of adolescents treated for ADHD

Objective To analyze the psychometric properties of the Norwegian version of the Weiss Functional Impairment Rating Scale parent and self-reports (WFIRS-P and WFIRS-S) in adolescents with ADHD. Methods 102 clinically referred patients, of which 86% were enrolled in an ongoing RCT program (Clinical trials NCT02937142), were diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Disorders version IV (DSM-IV). The conceptual framework of the WFIRS-P and the WFIRS-S was evaluated using confirmatory factor analysis (CFA), reliability was estimated using Cronbach’s alpha, convergent and divergent validity was assessed using correlations with the Children’s Global Assessment Scale (C-GAS) and the ADHD Rating Scale-IV (ADHD-RS-IV). Results CFA supported the original factor structure of the questionnaires, both a first-order and a second-order model revealed acceptable model fit. Internal consistency was satisfactory across domains. The parent-adolescent agreement was moderate. The correlations between the C-GAS and the total scores of the WFIRS-P and WFIRS-S were low to moderate (r = –0.29 to −0.38). The ADHD-RS-IV correlated moderately (r = 0.49) with WFIRS-P, the correlation with WFIRS-S was weak (r = 0.28) supporting divergent validity. In multiple regression analyses, the ADHD-RS total score was the strongest predictor of the total score in both the WFIRS questionnaires, with internalizing disorder showing an additional small contribution. Age, gender and full-scale IQ gave no additional contribution in explaining the variance. Conclusions The findings support the use of the Norwegian version of the WFIRS-S and the WFIRS-P in the evaluation of functional impairment in adolescents with ADHD.

A Phase III, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of Once-daily SPN-812 (Viloxazine Extended-release) in the Treatment of Attention-deficit/Hyperactivity Disorder in School-age Children

PurposeThe limitations of current US Food and Drug Administration (FDA)–approved medications for the treatment of attention-deficit/hyperactivity disorder (ADHD) set the need for the development of novel, effective, and tolerable medications to treat this disorder. The purpose of this study was to evaluate whether treatment with SPN-812 (viloxazine extended-release) significantly reduces symptoms of ADHD in children. MethodsThis study was a randomized, double-blind, placebo-controlled 6-week trial to assess the efficacy and safety of once-daily 100- and 200-mg SPN-812 in the treatment of ADHD in male and female children 6–11 years of age. Inclusion criteria required subjects to have a confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, ADHD diagnosis, an ADHD-Rating Scale-5 (ADHD-RS-5) score ≥28, a Clinical Global Impression-Severity score ≥4, and for subjects to be free of ADHD medication ≥1 week before randomization. The primary efficacy endpoint was the change from baseline (CFB) at end of study (EOS) in ADHD-RS-5 Total score. Key secondary endpoints included Clinical Global Impression-Improvement (CGI-I) scores at EOS and CFB at EOS in the Conners 3–Parent Short Form (Conners 3–PS) Composite T-score and the Weiss Functional Impairment Rating Scale–Parent (WFIRS–P) Total average score. Safety assessments included adverse events (AEs), laboratory tests, vital signs, physical examinations, ECGs, and the Columbia-Suicide Severity Rating Scale. The primary efficacy endpoint was analyzed by using a mixed model for repeated measures; all secondary measures were analyzed by using an ANCOVA model. ResultsA total of 477 subjects were randomized to treatment (intent-to-treat population, n = 460). The majority of subjects were male (63%) and either White (51.3%) or African American (43.7%). The demographic and baseline characteristics between the groups were similar. Statistically significant improvements in ADHD-RS-5 Total score were observed in both the 100- and 200-mg/day SPN-812 treatment groups compared to placebo at week 1 of treatment (P = 0.0004 and P = 0.0244, respectively), which was maintained through EOS (P = 0.0004 and P < 0.0001). Significant improvements were also observed at EOS in the CGI-I scale (P = 0.0020 and P < 0.0001), Conners 3–PS Composite T-score (P = 0.0003 and P = 0.0002), and WFIRS–P Total average score (P = 0.0019 and P = 0.0002) versus placebo. Treatment-related AEs reported in ≥5% of subjects included somnolence, decreased appetite, and headache. The discontinuation rate due to AEs was <5%. ImplicationsSPN-812 significantly reduced ADHD symptoms in children and was well tolerated. SPN-812 may prove to be an effective treatment for children with ADHD. ClinicalTrials.gov identifier: NCT03247530.

Review of Clinical Outcome Assessments in Pediatric Attention-Deficit/Hyperactivity Disorder.

PurposeVarious clinical outcome assessments (COAs) are used in clinical research to assess and monitor treatment efficacy in pediatric attention-deficit/hyperactivity disorder (ADHD) trials. It is unclear whether the concepts assessed are those that are important to patients and their caregivers. The concepts measured by commonly used COAs in this population have not been explicitly compared.MethodsWe conducted reviews of the qualitative literature to extract information on pediatric ADHD-related concepts reported by pediatric patients, parents, and teachers. Using these concepts, we developed a conceptual framework of pediatric ADHD using both the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria and the additional symptoms and behavioral impacts identified in the literature. We searched for COAs that have been used in pediatric ADHD research and mapped their items based on their conceptual underpinning.ResultsOf the 27 COAs found in the empirical literature, 4 COAs assessed only DSM symptoms. The most comprehensive coverage of our conceptual framework was seen in the Swanson, Nolan, and Pelham Rating Scale–DSM-IV (SNAP-IV). Eighteen COAs were used in at least 1 clinical trial: ADHD-Rating Scale-IV (ADHD-RS-IV) was used most often (n=77), followed by SNAP-IV (n=50), Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP; n=31), Weiss Functional Impairment Rating Scale (WFIRS; n=24), and Vanderbilt ADHD Diagnostic Rating Scale (VADRS; n=15).ConclusionWe identified symptoms and behavioral impacts from qualitative studies in pediatric ADHD that are not included in DSM-based criteria. Most COAs used in pediatric ADHD clinical trials measure only those symptoms listed in the DSM. While these COAs can measure symptom severity, they may not assess the full range of symptoms and impacts important to patients and their caregivers. Future research is needed to measure all concepts important to patients and caregivers within ADHD clinical trials.

Executive and Daily Life Functioning Influence the Relationship Between ADHD and Mood Symptoms in University Students

Objectives: Many studies have indicated a close relationship between ADHD and mood symptoms in university students. In the present study, we explore the role of daily functional impairments and executive functioning in the ADHD–mood relationship. Method: A total of 343 adults (126 males) filled out (a) the Conners’ Adult ADHD Rating Scale, (b) the Depression Anxiety and Stress Scale, (c) the Weiss Functional Impairment Rating Scale, and (d) the Executive Function Index Scale. Results: The correlation between mood symptoms and ADHD was .48 (moderate correlation) and dropped to .15 (weak correlation) when controlling for functional problems and executive functioning. Hierarchical regression analyses showed that both functional impairments and executive functioning significantly explained 42% to 53% of the variance of mood symptoms. The addition of ADHD symptoms to the model slightly increased the explained mood variance by only 1%. Conclusion: These findings underline the role of experienced difficulties in triggering mood symptoms in ADHD symptomatology.