Reducing disparities in behavioral health treatment in pediatric primary care: a randomized controlled trial comparing Partnering to Achieve School Success (PASS) to usual ADHD care for children ages 5 to 11 - study protocol.

BACKGROUND: Integrating behavioral health services into pediatric primary care can improve access to care, especially for children marginalized by poverty and racial/ethnic minority status. In primary care, a common presenting concern is attention-deficit/hyperactivity disorder (ADHD). Services in primary care for marginalized children with ADHD typically include medication alone; therapy to improve skills and build relationships is less available. This study evaluates the effectiveness of a behavioral intervention offered through primary care for marginalized families coping with ADHD (Partnering to Achieve School Success, PASS) compared to treatment as usual (TAU). METHOD: Three hundred participants will be randomly assigned to PASS or TAU. Participants include children ages 5 to 11 who have ADHD and are from economically marginalized families. PASS is a personalized, enhanced behavioral intervention that includes evidence-based behavior therapy strategies and enhancements to promote family engagement, increase caregiver distress tolerance, and provide team-based care to improve academic and behavioral functioning. TAU includes services offered by primary care providers and referral for integrated behavioral health or community mental health services. Outcomes will be assessed at mid-treatment (8 weeks after baseline), post-treatment (16 weeks), and follow-up (32 weeks) using parent- and teacher-report measures of service use, child academic, behavioral, and social functioning, parenting practices, family empowerment, and team-based care. Mixed effects models will examine between-group differences at post-treatment and follow-up. Analyses will examine the mediating role of parenting practices, family empowerment, and team-based care. Subgroup analyses will examine differential effects of intervention by child clinical characteristics and socioeconomic factors. DISCUSSION: This study is unique in targeting a population of children with ADHD marginalized by low socioeconomic resources and examining an intervention designed to address the challenges of families coping with chronic stress related to poverty. TRIAL REGISTRATION: This study was registered on clinicaltrials.gov (NCT04082234) on September 5, 2019, prior to enrollment of the first participant. The current version of the protocol and IRB approval date is October 4, 2023. Results will be submitted to ClinicalTrials.gov no later than 30 days prior to the due date for the submission of the draft of the final research report to the Patient-Centered Outcomes Research Institute.

Do Externalizing and Internalizing Symptoms Moderate Medication Response in Preschool Attention-Deficit/Hyperactivity Disorder? A DBPNet Study.

OBJECTIVES: This study aimed to determine whether parent ratings of attention-deficit/hyperactivity disorder (ADHD) symptom severity or externalizing symptoms (EXT) or internalizing symptoms (INT) moderate response to stimulants (STIM) and alpha-2 adrenergic agonists (A2As) in preschool ADHD. METHODS: Health records for children treated with medication for ADHD and with parent rating scale data available (N = 309; age <72 months) were reviewed at 7 Developmental-Behavioral Pediatric Research Network sites. Severity of ADHD was defined as the number of ADHD symptoms occurring often or very often on DSM-IV-based parent rating scales. EXT or INT from standardized rating scales were categorized as T score <60, 60 to <70, or ≥70. Ordinal logistic regression models predicting response to medication were calculated. RESULTS: The median (interquartile range) age at ADHD diagnosis was 59 (54-65) months. One hundred eighty-three participants had ADHD symptom severity, and 195 had EXT or INT data. ADHD severity was not associated with medication response. Both EXT and INT were associated with medication response but with significant medication class by EXT/INT interactions. Children with higher EXT were less likely to respond to STIM, with percentage of nonresponders for T-score categories <60, 60 to <70, and ≥70 being 3.6%, 25.7%, and 33.3% (p = 0.016) and, for A2As, being 60%, 50%, and 33.3% (p = 0.55), respectively. A similar pattern was observed for INT categories: STIM 19.4%, 22.5%, and 50.0% (p = 0.002) and A2As 42.3%, 30%, and 42.3% (p = 0.48), respectively. CONCLUSION: For preschool ADHD, low ratings of EXT or INT are associated with a high likelihood of response to STIM. By contrast, response rates to STIM and A2As are more similar for children with high levels of EXT or INT.

Receipt of Behavioral Therapy in Preschool-Age Children with ADHD and Coexisting Conditions: A DBPNet Study.

OBJECTIVE: Practice guidelines from the American Academy of Pediatrics and Society for Developmental and Behavioral Pediatrics recommend evidence-based behavioral therapy (BT) as first-line treatment for preschool-age children with ADHD, prior to medication initiation. Thus, this study's objective is to present the frequency of physician-documented receipt of BT in preschool-age children with ADHD prior to medication initiation and to determine factors associated with receipt BT receipt. METHODS: This retrospective medical record review was conducted across 7 Developmental Behavioral Pediatrics Research Network (DBPNet) sites. Data were abstracted for children <72 months old seen by a DBP clinician and initiated on ADHD medication between 1/1/2013-7/1/2017. From narrative text of the medical records, BT receipt was coded as: parent training in behavior management (PTBM), Applied Behavior Analysis (ABA), other, or did not receive. RESULTS: Of the 497 children in this study; 225 children (45%) had reported receipt of any BT prior to ADHD medication initiation, with 15.9% (n = 79) receiving PTBM. Children with co-existing diagnoses of ASD or disruptive behavior disorder were more likely to receive BT than children without co-existing conditions (59.3% vs 69.0% vs 30.6%). There was significant site variability in reported receipt of BT, ranging from 22.4% to 74.1%, and sex and insurance were not associated with BT rates. CONCLUSION: The percentage of children with documented receipt of any BT, and particularly PTBM, was low across all sites and co-existing conditions. These findings highlight the universal need to increase receipt of evidence-based BT for all young children with ADHD.

Provider and Caregiver Perspectives on Telehealth Assessments for Autism Spectrum Disorder in Young Children: A Multimethod DBPNet Study Exploring Equity.

BACKGROUND: Telehealth uptake increased dramatically during the COVID-19 pandemic, including for autism spectrum disorder (ASD) assessment by developmental-behavioral pediatric (DBP) clinicians. However, little is known about the acceptability of telehealth or its impact on equity in DBP care. OBJECTIVE: Engage providers and caregivers to glean their perspectives on the use of telehealth for ASD assessment in young children, exploring acceptability, benefits, concerns, and its potential role in ameliorating or exacerbating disparities in access to and quality of DBP care. METHODS: This multimethod study used surveys and semistructured interviews to describe provider and family perspectives around the use of telehealth in DBP evaluation of children younger than 5 years with possible ASD between 3/2020 and 12/2021. Surveys were completed by 13 DBP clinicians and 22 caregivers. Semistructured interviews with 12 DBP clinicians and 14 caregivers were conducted, transcribed, coded, and analyzed thematically. RESULTS: Acceptance of and satisfaction with telehealth for ASD assessments in DBP were high for clinicians and most caregivers. Pros and cons concerning assessment quality and access to care were noted. Providers raised concerns about equity of telehealth access, particularly for families with a preferred language other than English. CONCLUSION: This study's results can inform the adoption of telehealth in DBP in an equitable manner beyond the pandemic. DBP providers and families desire the ability to choose telehealth care for different assessment components. Unique factors related to performing observational assessments of young children with developmental and behavioral concerns make telehealth particularly well-suited for DBP care.

Adverse Effects of α-2 Adrenergic Agonists and Stimulants in Preschool-age Attention-deficit/Hyperactivity Disorder: A Developmental-Behavioral Pediatrics Research Network Study.

OBJECTIVES: To characterize and compare the type and frequency of a range of common and uncommon adverse effects (AEs) associated with α-2 adrenergic agonist (A2A) and stimulant treatment of attention-deficit/hyperactivity disorder at preschool-age as well as to evaluate the impact of age on common AEs. STUDY DESIGN: This was a retrospective electronic medical record review of children <72 months of age (n = 497) evaluated at outpatient developmental-behavioral pediatric practices at 7 US academic medical centers within the Developmental-Behavioral Pediatrics Research Network. Data on AEs were abstracted for children who had treatment initiated by a developmental-behavioral pediatrician with an A2A or stimulant medication between January 2013 and July 2017; follow-up was complete by February 2019. RESULTS: A2A and stimulants had distinctive AE profiles. A2A compared with stimulants had a greater proportion with daytime sleepiness and headaches; stimulants had significantly greater proportions for most other AE, including moodiness/irritability, difficulty with sleep, appetite suppression, stomachaches, skin picking/repetitive behaviors, withdrawn behavior, and weight loss. Younger age was associated with disruptive behavior and difficulty with sleep. CONCLUSIONS: Stimulants had a greater rate of most AEs compared with A2A. AE profiles, together with efficacy, should inform clinical decision-making. Prospective randomized clinical trials are needed to fully compare efficacy and AE profiles of A2A and stimulants.

Clinician Diagnostic Certainty and the Role of the Autism Diagnostic Observation Schedule in Autism Spectrum Disorder Diagnosis in Young Children.

Importance: Autism spectrum disorder (ASD) affects 1 in 44 children. The Autism Diagnostic Observation Schedule (ADOS) is a semi-structured observation developed for use in research but is considered a component of gold standard clinical diagnosis. The ADOS adds time and cost to diagnostic assessments. Objective: To evaluate consistency between clinical diagnosis (index ASD diagnosis) and diagnosis incorporating the ADOS (reference standard ASD diagnosis) and to examine clinician and child factors that predict consistency between index diagnoses and reference standard diagnoses. Design, Setting, and Participants: This prospective diagnostic study was conducted between May 2019 and February 2020. Developmental-behavioral pediatricians (DBPs) made a diagnosis based on clinical assessment (index ASD diagnosis). The ADOS was then administered, after which the DBP made a second diagnosis (reference standard ASD diagnosis). DBPs self-reported diagnostic certainty at the time of the index diagnoses and reference standard diagnoses. The study took place at 8 sites (7 US and 1 European) that provided subspecialty assessments for children with concerns for ASD. Participants included children aged 18 months to 5 years, 11 months, without a prior ASD diagnosis, consecutively referred for possible ASD. Among 648 eligible children, 23 refused, 376 enrolled, and 349 completed the study. All 40 eligible DBPs participated. Exposures: ADOS administered to all child participants. Main Outcomes and Measures: Index diagnoses and reference standard diagnoses of ASD (yes/no). Results: Among the 349 children (279 [79.7%] male; mean [SD] age, 39.9 [13.4] months), index diagnoses and reference standard diagnoses were consistent for 314 (90%) (ASD = 250; not ASD = 64) and changed for 35. Clinician diagnostic certainty was the most sensitive and specific predictor of diagnostic consistency (area under curve = 0.860; P < .001). In a multilevel logistic regression, no child or clinician factors improved prediction of diagnostic consistency based solely on clinician diagnostic certainty at time of index diagnosis. Conclusions and Relevance: In this prospective diagnostic study, clinical diagnoses of ASD by DBPs with vs without the ADOS were consistent in 90.0% of cases. Clinician diagnostic certainty predicted consistency of index diagnoses and reference standard diagnoses. This study suggests that the ADOS is generally not required for diagnosis of ASD in young children by DBPs and that DBPs can identify children for whom the ADOS may be needed.

Association of Coexisting Conditions, Attention-Deficit/Hyperactivity Disorder Medication Choice, and Likelihood of Improvement in Preschool-Age Children: A Developmental Behavioral Pediatrics Research Network Study.

Objectives: To determine whether conditions coexisting with attention-deficit/hyperactivity disorder (ADHD) in preschool-age children are associated with choice of stimulants or alpha-2 adrenergic agonists (A2As) and/or likelihood of improvement in ADHD symptoms. Methods: A retrospective electronic health record review of 497 children from 7 Developmental Behavioral Pediatrics Research Network (DBPNet) sites. Children were <72 months when treated with medication for ADHD from January 1, 2013 to July 1, 2017. We abstracted coexisting conditions, initial medication prescribed, and whether the medication was associated with improvement in symptoms. Analysis of improvement was adjusted for clustering by clinician and site. Results: The median (interquartile range) child age at the time of initiation of ADHD medication was 62 (54-67) months. The most common coexisting conditions included language disorders (40%), sleep disorders (28%), disruptive behavior disorders (22.7%), autism spectrum disorder (ASD; 21.8%), and motor disorders (19.9%). No coexisting conditions were present in 17.1%; 1 in 36.8%, 2 in 26.8%, and ≥3 in 19.3%. Stimulants were initially prescribed for 322 (64.8%) and A2A for 175 (35.2%) children. Children prescribed stimulants were more likely to have no coexisting conditions than those prescribed A2A (22.3% vs. 7.4%; p < 0.001). Coexisting ASD and sleep disorder were associated with increased likelihood of starting A2As versus stimulants (p < 0.0005; p = 0.002). The association between medication treatment and improvement varied by number of coexisting conditions for 0, 1, 2, or ≥3, respectively (84.7%, 73.8%, 72.9%, 64.6%; p = 0.031). Children with ≥3 coexisting conditions were less likely to respond to stimulants than children with no coexisting conditions (67.4% vs. 79.9%; p = 0.037). Conclusions: Among preschool-age children with ADHD, those with ≥3 coexisting conditions were less likely to respond to stimulants than those with no coexisting conditions. This was not found for A2A, but further research is needed as very few children with no coexisting conditions were treated with A2A.

α2-Adrenergic Agonists or Stimulants for Preschool-Age Children With Attention-Deficit/Hyperactivity Disorder.

Importance: Attention-deficit/hyperactivity disorder (ADHD) is diagnosed in approximately 2.4% of preschool-age children. Stimulants are recommended as first-line medication treatment. However, up to 25% of preschool-age children with ADHD are treated with α2-adrenergic agonist medications, despite minimal evidence about their efficacy or adverse effects in this age range. Objective: To determine the frequency of reported improvement in ADHD symptoms and adverse effects associated with α2-adrenergic agonists and stimulant medication for initial ADHD medication treatment in preschool-age children. Design, Setting, and Participants: Retrospective electronic health record review. Data were obtained from health records of children seen at 7 outpatient developmental-behavioral pediatric practices in the Developmental Behavioral Pediatrics Research Network in the US. Data were abstracted for 497 consecutive children who were younger than 72 months when treatment with an α2-adrenergic agonist or stimulant medication was initiated by a developmental-behavioral pediatrician for ADHD and were treated between January 1, 2013, and July 1, 2017. Follow-up was complete on February 27, 2019. Exposures: α2-Adrenergic agonist vs stimulant medication as initial ADHD medication treatment. Main Outcomes and Measures: Reported improvement in ADHD symptoms and adverse effects. Results: Data were abstracted from electronic health records of 497 preschool-age children with ADHD receiving α2-adrenergic agonists or stimulants. Median child age was 62 months at ADHD medication initiation, and 409 children (82%) were males. For initial ADHD medication treatment, α2-adrenergic agonists were prescribed to 175 children (35%; median length of α2-adrenergic agonist use, 136 days) and stimulants were prescribed to 322 children (65%; median length of stimulant use, 133 days). Improvement was reported in 66% (95% CI, 57.5%-73.9%) of children who initiated α2-adrenergic agonists and 78% (95% CI, 72.4%-83.4%) of children who initiated stimulants. Only daytime sleepiness was more common for those receiving α2-adrenergic agonists vs stimulants (38% vs 3%); several adverse effects were reported more commonly for those receiving stimulants vs α2-adrenergic agonists, including moodiness/irritability (50% vs 29%), appetite suppression (38% vs 7%), and difficulty sleeping (21% vs 11%). Conclusions and Relevance: In this retrospective review of health records of preschool-age children with ADHD treated in developmental-behavioral pediatric practices, improvement was noted in the majority of children who received α2-adrenergic agonists or stimulants, with differing adverse effect profiles between medication classes. Further research, including from randomized clinical trials, is needed to assess comparative effectiveness of α2-adrenergic agonists vs stimulants.

Preschool Attention-Deficit/Hyperactivity Disorder and Telephone Medication Management at Developmental-Behavioral Pediatric Network Sites.

OBJECTIVE: To understand developmental-behavioral pediatricians' (DBPs') use of clinic versus telephone encounters for preschool attention-deficit/hyperactivity disorder (ADHD) medication management. Understanding use of telephone encounters for pharmacologic management of ADHD in preschoolers may inform care for children with ADHD. METHODS: DBP investigators within Developmental Behavioral Pediatrics Research Network abstracted data from medical records of 503 children aged younger than 72 months treated for ADHD with medication by a DBP clinician between January 1, 2013, and July 1, 2017, across 7 sites. We abstracted data about medication treatment episodes (defined as start and end/change of a specific type, dose, and frequency of ADHD medication) and encounter type (clinic vs telephone). We present descriptive statistics related to encounter types and χ2 analyses to compare frequencies across reasons for the end of treatment episode and across sites. RESULTS: The study included 503 participants with a total of 1734 treatment episodes. The initial medication was started via a clinic encounter 85.9% of the time and via telephone encounters 14.1% of the time. When evaluating reasons for end of treatment episode, decreases in dose/frequency of medication were less common for clinic versus telephone encounters (27% vs 73%; p < 0.001) and adding an additional medication was more common at clinic versus telephone encounters (64% vs 36% p < 0.001). Sites varied significantly in frequency of telephone encounters, ranging from 16.9% to 68.9% (mean 45.7%). CONCLUSION: Telephone encounters were used for pharmacologic management of ADHD in preschoolers to varying degrees across 7 DBP sites. These findings suggest that telephone management serves an important role in ADHD care.

Implementation of targeted mental health interventions in urban schools: Preliminary findings for impact of training strategy on program fidelity.

School-based mental health programs are increasingly recognized as methods by which to improve children's access to evidence-based practices (EBPs), particularly in urban under resourced communities. School-wide positive behavior interventions and supports (PBIS) is one approach to integrating mental health services into school-based programming; however, school providers require training and support to implement programs as intended. We have conducted a randomized controlled trial to compare two models for training school-based personnel to deliver group EBPs to children at high risk of developing internalizing or externalizing problems. School personnel (N = 24) from 6 schools in a large urban school district were trained with either a basic training and consultation strategy, or an enhanced training and consultation strategy. Preliminary findings show that the enhanced strategy resulted in 9% higher content fidelity than the basic strategy. School personnel who were switched to the basic strategy had slightly lower content fidelity for the last two years of the trial and school personnel who continued to receive basic consultation during the step-down phase saw their fidelity decline. The two conditions did not differ with regard to process fidelity.

Group CBT for Externalizing Disorders in Urban Schools: Effect of Training Strategy on Treatment Fidelity and Child Outcomes.

Public schools are an ideal setting for the delivery of mental health services to children. Unfortunately, services provided in schools, and more so in urban schools, have been found to lead to little or no significant clinical improvements. Studies with urban school children seldom report on the effects of clinician training on treatment fidelity and child outcomes. This study examines the differential effects of two levels of school-based counselor training: training workshop with basic consultation (C) vs. training workshop plus enhanced consultation (C+) on treatment fidelity and child outcomes. Fourteen school staff members (counselors) were randomly assigned to C or C+. Counselors implemented a group cognitive behavioral therapy protocol (Coping Power Program, CPP) for children with or at risk for externalizing behavior disorders. Independent coders coded each CPP session for content and process fidelity. Changes in outcomes from pre to post were assessed via a parent psychiatric interview and interviewer-rated severity of illness and global impairment. Counselors in C+ delivered CPP with significantly higher levels of content and process fidelity compared to counselors in C. Both C and C+ resulted in significant improvement in interviewer-rated impairment; the conditions did not differ from each other with regard to impairment. Groups did not differ with regard to pre- to- posttreatment changes in diagnostic severity level. School-based behavioral health staff in urban schools are able to implement interventions with fidelity and clinical effectiveness when provided with ongoing consultation. Enhanced consultation resulted in higher fidelity. Enhanced consultation did not result in better student outcomes compared to basic consultation. Implications for resource allocation decisions with staff training in EBP are discussed.

A hybrid effectiveness-implementation cluster randomized trial of group CBT for anxiety in urban schools: rationale, design, and methods.

BACKGROUND: Schools present a context with great potential for the implementation of psychosocial evidence-based practices. Cognitive behavioral therapy (CBT) is an evidence-based practice that has been found to be very effective in treating anxiety in various community settings, including schools. Friends for Life (FRIENDS) is an efficacious group CBT protocol for anxiety. Unfortunately, evidence-based practices for anxiety are seldom employed in under-resourced urban schools, because many treatment protocols are not a good fit for the urban school context or the population, existing behavioral health staff do not receive adequate training or support to allow them to implement the treatment with fidelity, or school districts do not have the resources to contract with external consultants. In our prior work, we adapted FRIENDS to create a more culturally sensitive, focused, and feasible CBT protocol for anxiety disorders (CBT for Anxiety Treatment in Schools (CATS)). METHODS/DESIGN: The aim of this 5-year study is to evaluate both the effectiveness of CATS for urban public schools compared to the original FRIENDS as well as compare the implementation strategies (train-the-trainer vs. train-the-trainer + ongoing consultation) by conducting a three-arm, parallel group, type 2 hybrid effectiveness-implementation trial in 18 K-8 urban public schools. We will also assess the cost-effectiveness and the mediators and moderators of fidelity. Ninety therapists, 18 agency supervisors, and 360 children will participate. The interactive systems framework for dissemination and implementation guides the training and support procedures for therapists and supervisors. DISCUSSION: This study has the potential to demonstrate that agency therapists and supervisors who have had little to no prior exposure to evidence-based practices (EBPs) can implement an anxiety disorder EBP with fidelity. Comparisons of the implementation strategies would provide large urban mental health systems with data to make decisions about the adoption of EBPs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02651402.

A cluster randomized trial to evaluate external support for the implementation of positive behavioral interventions and supports by school personnel.

BACKGROUND: Urban schools lag behind non-urban schools in attending to the behavioral health needs of their students. This is especially evident with regard to the level of use of evidence-based interventions with school children. Increased used of evidence-based interventions in urban schools would contribute to reducing mental health services disparities in low-income communities. School-wide positive behavioral interventions and supports (SWPBIS) is a service delivery framework that can be used to deliver universal preventive interventions and evidence-based behavioral health treatments, such as group cognitive behavioral therapy. In this article, we describe our ongoing research on creating internal capacity for program implementation. We also examine the cost-effectiveness and resulting school climate when two different levels of external support are provided to personnel as they implement a two-tier SWPBIS program. METHODS/DESIGN: The study follows six K - 8 schools in the School District of Philadelphia randomly assigned to consultation support or consultation-plus-coaching support. Participants are: approximately 48 leadership team members, 180 school staff and 3,900 students in Tier 1, and 12 counselors, and 306 child participants in Tier 2. Children who meet inclusion criteria for Tier 2 will participate in group cognitive behavioral therapy for externalizing or anxiety disorders. The study has three phases, baseline/training, implementation, and sustainability. We will measure implementation outcomes, service outcomes, child outcomes, and cost. DISCUSSION: Findings from this study will provide evidence as to the appropriateness of school-wide prevention and treatment service delivery models for addressing services disparities in schools. The effectiveness and cost-effectiveness analyses of the two levels of training and consultation should help urban school districts and policymakers with the planning and deployment of cost-effective strategies for the implementation of evidence-based interventions for some of the most common behavioral health problems in school children. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01941069.