Collaborative Care for Children With ADHD Symptoms: A Randomized Comparative Effectiveness Trial

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Collaborative Care for Children With

ADHD Symptoms: A Randomized

Comparative Effectiveness Trial

Michael Silverstein, MD, MPHa_{, L. Kari Hironaka, MD, MPH}a_{, Heather J. Walter, MD, MPH}b_{, Emily Feinberg, ScD}a,c_, Jenna Sandler, MPHa_{, Michelle Pellicer, MPH}a_{, Ning Chen, MA}a_{, Howard Cabral, PhD, MPH}d

abstract

OBJECTIVES:Although many attention-deﬁcit/hyperactivity disorder (ADHD) care models have

been studied, few have demonstrated individual-level symptom improvement. We sought to test whether complementing basic collaborative care with interventions that address common reasons for symptom persistence improves outcomes for children with inattention and hyperactivity/impulsivity.

METHODS:We conducted a randomized comparative effectiveness trial of 2 care management systems for 6- to 12-year-old children being evaluated for ADHD (n= 156). All participants received care management with decision support. Care managers in the enhanced care arm also were trained in motivational and parent management techniques to help parents engage in their child’s treatment, address their own mental health needs, and manage challenging child behaviors. We used multivariable models to assess inattention, hyperactivity/impulsivity, oppositionality, and social skills over 1 year.

RESULTS:Both treatment arms generated guideline concordant diagnostic processes in 94% of cases; 40% of children had presentations consistent with ADHD. For the entire sample, there were no differences in symptom trajectories between study arms; mean differences in change scores at 12 months were–0.14 (95% conﬁdence interval–0.34 to 0.07) for inattention;–0.13 (–0.31 to 0.05) for hyperactivity/impulsivity;–0.09 (–0.28 to 0.11) for oppositionality; and 3.30 (–1.23 to 7.82) for social skills. Among children with ADHD-consistent presentations, enhanced arm participants experienced superior change scores for hyperactivity/impulsivity of–0.36 (–0.69 to–0.03), oppositionality–0.40 (–0.75 to –0.05), and social skills 9.57 (1.85 to 17.28).

CONCLUSIONS:Among children with ADHD-consistent presentations, addressing barriers to engagement with care and challenging child behaviors has potential to improve the effectiveness of collaborative care.

WHAT’S KNOWN ON THIS SUBJECT:Collaborative care is known to be an effective system to manage child behavioral health conditions in the primary care setting.

WHAT THIS STUDY ADDS:Among urban children with attention-deﬁcit/hyperactivity disorder, using lay care managers to address barriers to engagement with care and challenging child behaviors has the potential to improve the effectiveness of conventional collaborative care.

Departments ofa_{Pediatrics, and}b_{Psychiatry, Boston University School of Medicine, Boston Medical Center, Boston,}

Massachusetts; and Departments ofcCommunity Health Sciences, anddBiostatistics, Boston University School of Public Health, Boston, Massachusetts

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Attention-deﬁcit hyperactivity disorder (ADHD) affects 8% to 12% of US school-aged children.1_{Far more}

children, however, demonstrate functionally impairing inattention or hyperactivity/impulsivity, but do not meet full diagnostic criteria for ADHD. Although most children with ADHD symptoms are managed by their primary care provider,2,3

diagnostic processes and treatment plans in this setting often fail to uphold evidence-based standards.4

To address this gap between evidence and practice, a number of ADHD care management models have been developed. These models have focused largely on communication of patient data or assistance with medical decision-making (decision support) and have succeeded in improving guideline adherence for ADHD diagnosis and management.5–7

There is a paucity of literature, however, on the impact of these care models on individual level outcomes.

One approach to improving outcomes is to augment evidence-based models of care with lay-delivered

interventions designed to address speciﬁc reasons for lack of clinical improvement. This approach could be particularly important for low-income and minority children, who have limited access to mental health specialists and often receive their care in underresourced settings.8,9

Although many reasons for symptom persistence exist, 3 reasons may be particularly salient for urban children. First, engagement with behavioral health care is often problematic.10–14

Second, low-income parents, particularly those of inattentive or hyperactive/impulsive children, have an increased prevalence of depression and adult ADHD,15_{which have been}

associated with poorer child symptom trajectories.16,17_{Third, behavioral}

comorbidities, particularly

oppositionality, are highly prevalent among low-income populations, and can limit the effectiveness of strategies designed to address core ADHD symptoms.18,19

In this context, we conducted a randomized comparative

effectiveness trial to test the hypothesis that augmenting a basic collaborative care system (whereby primary care clinicians work with specialists via care manager intermediaries) with

interventions to address speciﬁc reasons for protracted symptoms could improve outcomes for low-income children with inattention and hyperactivity/impulsivity. Because we were interested in real-world applicability in a Medical Home context,20_{all care management}

processes were conducted by lay providers without formal mental health backgrounds; and study procedures, whenever possible, adhered to principles of effectiveness research.21

Because we were interested in symptomatic improvement among all children presenting to primary care with relevant behavioral concerns, we enrolled subjects at the point of initiation of an ADHD workup, as opposed to the point of diagnosis.

In our 2-arm trial, all participants received care management and decision support, based largely on evidence-based collaborative care models that have been applied to different clinical populations.22,23

Care managers in the enhanced study arm also were trained in motivational interviewing techniques to help parents engage with care for their children, and to seek care for their own behavioral health concerns.24

These care managers also were trained in Triple P’s Primary Care module, a series of techniques effective in reducing coercive parenting and behavioral problems in children.25–27_{We followed families}

for 1 year and measured children’s inattention, hyperactivity/impulsivity, oppositionality, and social skills.

METHODS

Study Design and Setting

We conducted a 2-site, parallel-group comparative effectiveness trial with 1:1 randomization. Both sites were

urban primary care pediatric practices serving low-income

populations: one, within an academic medical center; the other,

a community health center.

Participants

We recruited 6- to 12-year-old children, whose primary care provider initiated an evaluation for ADHD based on parental report of inattentive or hyperactive/impulsive behavior. Those with existing ADHD diagnoses, documentation of autism spectrum or bipolar disorder, and those already receiving care from a pediatric neurologist, psychiatrist, or developmental-behavioral pediatrician were excluded. We restricted our sample to English- and Spanish-speaking families.

Recruitment and Enrollment

We enrolled participants from October 2010 to July 2013. To emulate real-world circumstances, primary care providers initiated evaluations for ADHD at their own discretion, and made referrals via the electronic medical record for care management. A central coordinator offered care management services, irrespective of participation in the trial. Those participating in the trial subsequently met with study staff, who obtained written informed consent.

Randomization

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Interventions

Both study arms were modeled on the concept of collaborative care. We retained lay care managers

(bachelor’s or master’s level) without formal mental health training or clinical experience. Care managers’ responsibilities were threefold:ﬁrst, they obtained symptom reports, by using the Vanderbilt ADHD Diagnostic Rating scales,28_{from both parents}

and teachers. These scales were obtained as part of the initial diagnostic process, and the ongoing monitoring process for those with ADHD-consistent presentations. To obtain teacher ratings, care managers sent forms, along with a signed release, to a centralized school administrator who in turn contacted teachers. Second, care managers received brief training in medical history taking, and obtained clinical information from families on behavioral symptoms and social and family history. Third, care managers served as liaisons between primary care providers and a decision support panel consisting of 1 child

psychiatrist (HJW), 1 developmental-behavioral pediatrician (LKH), and 1 primary care pediatrician.

Decision support focused on whether clinical presentations were consistent with ADHD (combined, inattentive, hyperactive/impulsive, or not-otherwise-speciﬁed types), or whether alternative diagnoses should be entertained. An“ADHD-consistent presentation”was deﬁned as meeting

Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, symptom criteria on both the parent and teacher Vanderbilt scales, in the absence of a plausible alternative explanation for the child’s symptoms, as determined from narrative clinical information. If an ADHD diagnosis was conﬁrmed by the primary care provider, the decision support team provided guideline-concordant pharmacological guidance,29_and

advice on monitoring and treating to a target symptom score. Decision

support was phrased in nonspeciﬁc terms: for example, if a suggestion was made to start a stimulant medication, a speciﬁc medication was not named. For those with ADHD-inconsistent presentations, the decision support team provided guidance about diagnostic next steps. The electronic health record provided the medium for communication.

Enhanced care managers received additional training to address 3 common reasons for ADHD symptom persistence: ambivalence toward engagement with behavioral health care,14_{parental mental health,}30_and

oppositional child behavior.18_To

address theﬁrst 2, care managers were trained in motivational interviewing31

and followed a standardized script to resolve ambivalence toward treatment. Consistent with previous work,25_care

managers used motivational interviewing principles to explore parents’stressors, and to offer referrals to adult behavioral health services if indicated. Last, enhanced care managers were certiﬁed by a master trainer in Triple P’s Primary Care module. Whereas basic care managers conducted their work in person only until the initial diagnostic decision support meeting (and by telephone thereafter), enhanced care managers met with clients in person as often as necessary to accomplish these aims.

Intervention Training and Fidelity All enhanced care managers underwent a 5-day training in motivational interviewing conducted by a trainer certiﬁed by the

Motivational Interviewing Network of Trainers, and were judged to have appropriate skills on assessment of videotaped interactions with standardized patients. Because our study was an effectiveness trial, we took an unobtrusive approach to care manager supervision andﬁdelity monitoring.21_{Skills were maintained}

through weekly supervision sessions with a social worker and through annual booster sessions with the motivational interviewing trainer.

During these annual sessions, the trainer assessed skills based on a standard set of criteria consistent with best practices in motivational interviewing.31_{Triple P training}

involved a commercially available training and certiﬁcation module. We implemented Triple P as it would be in a real-world practice setting and did not deploy any additional training than provided in the original module.

Measures and Outcome Assessment At baseline, we recorded the age and gender of all children. We chose our outcome measures to be congruent with the Multimodal Treatment of ADHD Study,32_{a seminal study}

comparing treatment approaches for children with ADHD. We used the Swanson, Nolan, and Pelham (SNAP-IV) scale to assess behavioral symptoms. This scale, which has a range of 0 to 3, has a factor structure that includes 2 ADHD subscales (inattention and hyperactivity/ impulsivity) and an oppositionality subscale.33_{We used standard scores}

from Social Skills Rating System to assess children’s social skills.34_For

adult caregivers, we assessed age, relationship to the child, marital and work status, education, and race and ethnicity. We assessed caregiver depressive symptoms by using the Quick Inventory of Depressive Symptoms35_{; adult ADHD symptoms,}

by using the Adult ADHD Self-Report Scale36_{; and health literacy, by using}

the Brief Test of Functional Health Literacy.37_{For each measure, we used}

published clinical cutpoints.

Our primary outcome was ADHD symptoms, measured by parent SNAP-IV report, 6 and 12 months after randomization. Secondary outcomes included oppositional symptoms and social skills.

Statistical Analysis

We conducted an intention-to-treat analysis, excluding 1 subject who was found to be ineligible

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from baseline for inattention, hyperactivity/impulsivity,

oppositionality, and social skills, we used 2-samplet-tests.

By using multivariable linear regression models, we assessed differences in symptom changes across intervention groups, accounting for relevant baseline differences, and enrollment site as aﬁxed effect.38_{We calculated}

standardized effect sizes as the adjusted difference between groups divided by the pooled SD, by using the Cohen d statistic. We conducted stratiﬁed analyses to determine if there was differential impact among children whose presentations were consistent, or inconsistent, with ADHD. We assessed effect modiﬁcation by ADHD-consistent presentation by entering treatment arm–by–ADHD interaction terms into the models. Because outcomes data were missing in only 9% of subjects, we employed no special techniques to handle missing data.

To explore possible intervention mechanisms of action, we

supplemented the intention-to-treat analysis with an as-treated analysis, in which we divided the sample into those receiving no enhanced care sessions, those receiving 1 to 3 sessions, and those receiving 4 to 5 sessions, irrespective of random assignment. We analyzed differences in outcomes via analysis of variance, restricting this analysis to 12-month outcomes because all intervention “doses”had been delivered by this time. We used thex2test to assess differences between study groups in ADHD medication prescription receipt and receipt of specialty behavioral health services. Small cell sizes precluded formal

mediation analyses or multivariable modeling of potential mechanistic pathways.

Sample Size

We estimated our sample size to generate adequate power to test

a clinically signiﬁcant difference across intervention arms on decreasing SNAP-IV scores over 12 months. We assumed from the Multimodal Treatment of ADHD study that at baseline, SNAP-IV scores would average 2.2 (SD 0.70).39_We

assumed that among subjects in the basic arm, follow-up scores would average 1.8 at 6 months and 1.4 at 12 months; in the enhanced arm, 1.7 at 6 months and 1.1 at 12 months, differences in score trajectories considered clinically signiﬁcant.42,43

We assumed a 2-sidedaof 0.05, 80% power, and 10% loss to follow-up, leading to our goal of randomizing 156 subjects.

The Boston University Medical Center Institutional Review Board approved this study (Clinical Trials.gov NCT01275378).

RESULTS Enrollment

Primary care providers referred 418 children to the central coordinator (Fig 1). Of these, 116 did not meet inclusion criteria, 100 could not be contacted, and 46 refused to

participate. Of the 156 subjects in the trial, 114 were recruited from the hospital clinic. One subject in the basic care arm was found to be ineligible after randomization and excluded. Of the 155 eligible, randomized subjects, 141 (91%) were assessed at the 12-month follow-up point.

Baseline Characteristics Our sample of children was predominantly male (69%), with a mean age of 8.73 years (SD 2.07). The sample was 60% black and 27% Latina. Most baseline characteristics were balanced between the 2 study groups (Table 1); however, whereas 76% of caregivers in the enhanced care arm had attained a high school diploma, 63% in the basic care arm had. Overall, randomization appeared to be effective.

Baseline child inattention, hyperactivity/impulsivity, oppositionality, and social skills scores reﬂected a study population with the expected behavioral challenges. Based on SNAP-IV norms, 54% of the children in the sample scored in the top 5%, nationally, for inattention; 68%, in the top 5% for hyperactivity/impulsivity; and 31% in the top 5% for oppositionality. The mean rank of children in our sample for social skills was the 23rd percentile nationally. None of these scores differed between intervention groups at baseline.

Process Data

Initial steps of the ADHD diagnostic process for children in both care groups adhered well to established quality metrics, including evaluation with symptom inventories and assessment of comorbid conditions (Table 2). Overall, 40% of cases were judged to be consistent with ADHD. By design, basic care managers did not meet with families in person after initial decision support was

provided; by contrast, enhanced care managers had up to 5 in-person follow-up meetings (mean, 1.58; SD 1.73) with their clients. All enhanced care managers were deemed to have maintained motivational interviewing skills throughout the study period. Thirty-seven study parents (47%) in the enhanced care arm engaged in at least 1 aspect of Triple P; 7 parents (9%) engaged in a discussion about their own mental health. There were no known adverse events in either arm.

Inattention, Hyperactivity/ Impulsivity, Oppositionality, and Social Skills

At both 6 and 12 months of follow-up, mean changes in scores for

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through 6 and 12 months demonstrated no signiﬁcant differences across study arms (Table 4).

Subgroup Analyses

Among children with ADHD-consistent presentations, multivariable models estimating differences in symptom changes from baseline demonstrated better trajectories among those receiving enhanced care (Table 4). At

12 months, those in the enhanced arm experienced greater

improvements in hyperactivity/ impulsivity (–0.36; 95% conﬁdence interval [CI]–0.69 to–0.03),

oppositionality (–0.40; 95% CI–0.75 to–0.05), and social skills (9.57; 95% CI 1.85 to 17.28) than those in the basic arm. Effect sizes for these outcomes were moderate to large: 0.57 for hyperactivity/impulsivity, 0.55 for oppositionality, and 0.69 for social skills. Treatment arm-by-ADHD

interaction terms indicated statistically signiﬁcant effect modiﬁcation for each of these measures (P= .04 for hyperactivity/impulsivity,P= .02 for oppositionality,P= .01 for social skills).

Intervention Dose, Medication Prescription and Specialty Behavioral Health Care

An unadjusted as-treated analysis suggested better 12-month change scores for inattention (P= .07) and social skills (P= .04) among children FIGURE 1

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with ADHD-consistent presentations, whose families received 1 to 3 enhanced care sessions. Whereas the proportion of children with

ADHD-consistent presentations to receive specialty behavioral health services was similar across study arms, there was a clinically

meaningful (but statistically nonsigniﬁcant) difference in the proportion of children with ADHD-consistent presentations to be prescribed an ADHD medication (52% in basic care versus 72% in enhanced care;P= .10).

DISCUSSION

Our study tested the comparative effectiveness of 2 collaborative care systems on urban children’s trajectories of inattention, hyperactivity/impulsivity, oppositionality, and social skills. Across the entire sample, there were no differences in outcomes between study arms. However, among children with ADHD-consistent presentations, those in the enhanced care arm experienced better symptom trajectories than those in the basic care arm. Among this subgroup, differences between arms appeared greater in the second half of the follow-up period than theﬁrst, with moderate to large effect sizes observed.

Consistent with recent novel approaches to pediatric behavioral health,23,41_{we enrolled children in}

our trial based on presenting symptoms, as opposed to ultimate diagnoses. This family-centered approach represents a departure from much of the extant ADHD literature. Furthermore, whereas most studies to date have tested care systems against usual care, our trial is novel in studying whether augmenting collaborative care with lay-delivered strategies to address common reasons for symptom persistence improves outcomes. These dimensions, along with our emphasis on urban, low-income children, make our results relevant to primary care providers, those interested in operationalizing the principles of the Medical Home,20

and those interested in designing care for vulnerable populations.

Because our intervention has multiple facets, determining which TABLE 1 Baseline Characteristics by Study Group

Enhanced Collaborative Care,n= 78

Basic Collaborative Care,n= 77 Mean child age, y (SD) 8.69 (1.95) 8.67 (2.14)

Boys,n(%) 55 (71) 52 (67)

Child SNAP-IV scores (SD)

Inattentive subscale 1.94 (0.56) 1.81 (0.62) Hyperactive/impulsive subscale 1.79 (0.78) 1.78 (0.77) Oppositional deﬁant subscale 1.31 (0.78) 1.39 (0.74) Social Skills Rating Scale scores (SD) 82.51 (16.65) 84.96 (16.19) Caregiver relation to child,n(%)

Mother 69 (88) 68 (87)

Father 4 (5) 4 (5)

Legal guardian 5 (6) 6 (8)

Mean caregiver age, y (SD) 36.59 (9.30) 37.38 (8.27)

Black,n(%) 48 (62) 46 (59)

Latina,n(%) 19 (24) 23 (29)

US born,n(%) 48 (62) 50 (66)

High school graduate,n(%) 60 (77) 49 (63) Work outside home,n(%) 36 (46) 37 (47) Mean depression score (SD) 6.94 (4.76) 7.60 (5.04) Parent with symptoms of adult ADHD,n(%) 16 (21) 18 (23) Inadequate parental health literacy,n(%) 12 (16) 13 (17) Recruited from hospital site,n(%) 57 (73) 57 (73) Recruited from community health center,n(%) 21 (27) 21 (27)

TABLE 2 Clinical and Process Data

Basic Collaborative Care,n= 77 Diagnostic assessment

Decision support assessment consistent with ADHD (%) 34 (44) 29 (37) ADHD inattentive (%) 11 (14) 8 (10) ADHD hyperactive/impulsive (%) 4 (5) 7 (9) ADHD combined type (%) 15 (19) 12 (15) Quality metrics

Evaluated with parent Vanderbilt scale (%) 76/76 (100) 76/76 (100) Evaluated with teacher Vanderbilt scale (%) 76/76 (100) 71/76 (93) Coexistent conditions assessed (%) 76/76 (100) 72/75 (96) Number of in-person meetings with care manager after initial decision support

0 36 —

1 8 —

2 9 —

3 4 —

4 20 —

5 1 —

Number to receive an ADHD medication prescription (% among those with ADHD-consistent presentations)

23 (72) 15 (52)

Number to receive specialty behavioral health (% among those with ADHD-consistent presentations)

16 (52) 14 (50)

Key care management processes

Received Triple P (%) 37/78 (47) — Discussed maternal mental health (%) 7/78 (9) —

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model component was responsible for the observed differences among children with ADHD-consistent presentations is difﬁcult. Because only 9% of enhanced care parents discussed their own mental health, it is unlikely that this component was critical. Similarly, because receipt of specialty behavioral health services was equal across intervention groups, this was also unlikely a key driver of outcomes. By contrast, although there

is no direct evidence that Triple P was responsible for our results, its uptake among enhanced care families was nearly 50%, and it could well explain enhanced care’s preferential impact on hyperactivity/impulsivity. Last, among children with ADHD-consistent presentations in the enhanced care group, there was a clinically meaningful increase in ADHD medication prescriptions. Given that the motivational

interviewing script deliberately focused on medication use, it is possible that motivational interviewing started a cascade of events leading to increased

receptivity to ADHD medication, and that this, in turn, could have led to improved outcomes.

The principal strengths of our study are its comparative effectiveness design and real-world applicability. These particular strengths, however, TABLE 3 ADHD and ODD Symptoms and Social Skills at 6 and 12 Months

6-mo Outcomes 12-mo Outcomes

Basic Collaborative Care,n= 73

P Enhanced Collaborative Care,n= 71

Basic Collaborative Care,n= 71

P

Main effects

Mean SNAP IV inattention score (SD) 20.29 (0.65) 20.29 (0.60) .98 20.38 (0.73) 20.25 (0.53) .19 Mean SNAP IV hyperactivity/

impulsivity score (SD)

20.24 (0.56) 20.33 (0.53) .31 20.44 (0.59) 20.32 (0.53) .20

Mean SNAP IV ODD score (SD) 20.14 (0.55) 20.19 (0.55) .59 20.31 (0.65) 20.23 (0.52) .43 Mean social skills standard score (SD) 2.81 (11.95) 2.29 (9.84) .77 5.54 (15.46) 2.35 (11.82) .18 ADHD consistent presentation n= 30 n= 28 n= 29 n= 27

20.40 (0.60) 20.15 (0.40) .07 20.53 (0.78) 20.17 (0.43) .04

Mean SNAP IV ODD score (SD) 20.24 (0.62) 20.13 (0.62) .50 20.40 (0.77) 20.04 (0.51) .04 Mean social skills standard score (SD) 4.23 (13.70) 3.04 (9.30) .70 10.21 (17.53) 0.48 (10.34) .01 ADHD inconsistent presentation n= 43 n= 45 n= 42 n= 44

20.12 (0.50) 20.44 (0.58) .01 20.37 (0.41) 20.40 (0.57) .75

Mean SNAP IV ODD score (SD) 20.08 (0.49) 20.24 (0.51) .15 20.24 (0.56) 20.35 (0.50) .36 Mean social skills standard score (SD) 1.81 (10.62) 1.82 (10.23) 1.00 2.14 (13.07) 3.50 (12.62) .63

Lower scores indicate fewer symptoms for all SNAP-IV measures; higher scores indicate better social skills. ODD, oppositional deﬁant disorder.

TABLE 4 Multivariable Symptom Change Models

Outcome Difference in Symptom Score Between Enhanced and Basic Collaborative Care Groups

6 mon= 146 12 mon= 142

Mean Difference (95% CI) Effect Size Mean Difference (95% CI) Effect Size Main effects

SNAP inattention score 0.00 (–0.21 to 0.20) 0.00 20.14 (–0.34 to 0.07) 0.21 SNAP hyperactivity/impulsivity score 0.09 (–0.09 to 0.27) 20.17 20.13 (–0.31 to 0.05) 0.20 SNAP ODD score 0.05 (–0.13 to 0.23) 20.09 20.09 (–0.28 to 0.11) 0.17 Social skills score 0.59 (–2.98 to 4.16) 20.06 3.30 (–1.23 to 7.82) 0.23 ADHD consistent presentation

SNAP inattention score 20.05 (–0.37 to 0.27) 0.08 20.16 (–0.50 to 0.18) 0.24 SNAP hyperactivity/impulsivity score 20.22 (–0.48 to 0.04) 0.49 20.36 (–0.69 to–0.03) 0.57 SNAP ODD score 20.10 (–0.42 to 0.23) 0.18 20.40 (–0.75 to–0.05) 0.55 Social skills score 1.68 (–4.49 to 7.85) 0.13 9.57 (1.85 to 17.28) 0.69 ADHD inconsistent presentation

SNAP inattention score 0.02 (–0.25 to 0.28) 20.05 20.15 (–0.41 to 0.10) 0.19 SNAP hyperactivity/impulsivity score 0.31 (0.08 to 0.54) 20.58 0.03 (–0.18 to 0.24) 20.08 SNAP ODD score 0.14 (–0.06 to 0.34) 20.31 0.09 (–0.13 to 0.31) 20.11 Social skills score 20.01 (–4.35 to 4.32) 0.00 21.14 (–6.46 to 4.17) 20.10

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introduce 2 important limitations. Theﬁrst is that disentangling the impact of individual intervention components, which likely act both independently and

interdependently,42,43_{often requires}

strict standardization in intervention implementation, which is largely impossible in an effectiveness design.44_{This, combined with the fact}

that we would not expect the beneﬁts of enhanced care to accrue through the same pathway for all study participants, limits our ability to isolate key mediating factors of our model. Second, staying true to an effectiveness study design limits us to monitoring interventionﬁdelity through unobtrusive means,21_which

are inherently less exacting than techniques typically used in efﬁcacy trials.

Additionally, our study was

conducted in a single geographic area. Most of our subjects attended school in a district in which there was usually not a single, easily identiﬁable teacher who knew the child best; therefore, we conﬁned our outcome assessments to parent report. Although a limitation, this approach to measuring outcomes is

consistent with existing studies of collaborative behavioral health care for children,41_{and previous work}

indicates that our outcome measures tend to be stable across parent and teacher reports.39

With these limitations in mind, it appears that adding certain theory-based components to a basic collaborative care system produces no added beneﬁt for a population of

urban children with symptoms of inattention and hyperactivity/ impulsivity. However, among children with presentations

consistent with ADHD, using lay care managers to address barriers to engagement and challenging child behaviors could have some added beneﬁt. Because our positive

findings occurred in a study subgroup, as opposed to the main sample, thesefindings need to be replicated in a larger study, powered not only to confirm intervention impact, but also to decipher its mechanism of action.

ACKNOWLEDGMENTS

We thank Megan Bair-Merritt for her thoughtful review of the manuscript.

This trial has been registered at www.clinicaltrials.gov (identiﬁer NCT01275378). www.pediatrics.org/cgi/doi/10.1542/peds.2014-3221

DOI:10.1542/peds.2014-3221 Accepted for publication Jan 15, 2015

Address correspondence to Michael Silverstein, MD, MPH, Vose Hall 3, Boston Medical Center, Boston, MA 02118. E-mail: [email protected]

FINANCIAL DISCLOSURE:The authors have indicated they have noﬁnancial relationships relevant to this article to disclose.

FUNDING:Health Resources and Services Administration, Maternal Child Health Bureau, grant R40MC17181.

POTENTIAL CONFLICT OF INTEREST:The authors have indicated they have no potential conﬂicts of interest to disclose.

COMPANION PAPER:A companion to this article can be found on page e1042, online at www.pediatrics.org/cgi/doi/10.1542/peds.2015-0070.

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DOI: 10.1542/peds.2014-3221 originally published online March 23, 2015;

2015;135;e858

Pediatrics

Sandler, Michelle Pellicer, Ning Chen and Howard Cabral

Michael Silverstein, L. Kari Hironaka, Heather J. Walter, Emily Feinberg, Jenna

Comparative Effectiveness Trial

Collaborative Care for Children With ADHD Symptoms: A Randomized

Services

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Collaborative Care for Children With ADHD Symptoms: A Randomized Comparative Effectiveness Trial

Collaborative Care for Children With

ADHD Symptoms: A Randomized

Comparative Effectiveness Trial

abstract