Results Summary and Professional Abstract

Results Summary

Results Summary

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What was the research about?

Attention-deficit/hyperactivity disorder, or ADHD, is a condition that makes it hard for people to focus and organize their activities. Youth with ADHD may have behavior problems at home and school. Some studies have shown that therapy and medicine can improve symptoms and functioning at school.

In this study, the research team compared two approaches for helping youth with ADHD:

• Therapy alone: Therapists held sessions with youth and families to help youth improve school functioning. The sessions focused on topics like homework, organization, and attendance. Therapists also worked to engage families with school services.
• Therapy plus support for making decisions about medicines, called integrated care: Youth received therapy. Therapists also taught families about ADHD, medicines to treat it, and ways that families can decide whether youth should take medicine.

The research team looked at how well the approaches helped reduce ADHD symptoms and improve behavior and school functioning. The team also tracked how often youth saw their therapists and used ADHD medicine.

What were the results?

Compared with youth who received therapy alone, youth who received integrated care reported

• Increased ability to pay attention
• Fewer behavior problems

Youth in the two groups didn’t differ in

• Impulse control
• Mood
• Drug and alcohol use
• School functioning, such as grades and minutes spent on homework
• How often youth saw therapists or their doctors about ADHD medicines
• Use of ADHD medicines

Who was in the study?

The study included 145 youth with ADHD. All were receiving care at one of five mental health clinics in the New York City metro area. Of the youth, 42 percent were white, 15 percent were African American, and 6 percent were more than one race; 37 percent were Hispanic. The average age was 15, and 72 percent were boys.

What did the research team do?

The research team assigned therapists by chance to provide either therapy alone or integrated care when treating youth with ADHD.

The research team interviewed youth and their caregivers about their mental health and school functioning before therapy and then 3, 6, and 12 months later. The team also looked at health records to learn how often youth went to therapy and how often they saw their doctors about medicine.

Researchers, youth and family advocates, people who worked at mental health clinics, and youth with ADHD and their caregivers gave input about the study design and data collection.

What were the limits of the study?

The study took place in five clinics in one metro area. Findings may differ in other places. Therapists volunteered to be part of the study. Findings might have been different if the research team chose therapists by chance.

Future research could compare the two approaches in other places.

How can people use the results?

Therapists, youth, and their parents can use these results when considering approaches to decrease ADHD symptoms and improve behavior.

Professional Abstract

Professional Abstract

Objective

To compare the effectiveness of behavioral treatment augmented by medication decision-making assistance versus behavioral treatment alone in improving functioning and service utilization among adolescents with attention-deficit/hyperactivity disorder (ADHD)

Study Design

Design Elements	Description
Design	Randomized controlled trial
Population	Population 145 adolescents ages 12–18 with ADHD seeking treatment in 1 of 5 outpatient behavioral health clinics
Interventions/ Comparators	Behavioral treatment alone: therapists provided academic support focusing on organization, attendance, and family engagement Integrated treatment: behavioral treatment augmented by family-based assistance for making medication decisions
Outcomes	Primary: adolescent- and caregiver-reported ADHD symptoms (inattention, hyperactivity/impulsivity), adolescent- and caregiver-reported mood problems, adolescent-reported delinquency and substance (drug and alcohol) use, caregiver-reported executive functioning (self-regulation, self-organization), school functioning (adolescent-reported grades and self-efficacy, caregiver-reported homework issues) Secondary: treatment attendance, medication management, caregiver-reported adolescent medication use
Timeframe	1-year follow-up for primary outcomes

This cluster-randomized trial compared the effectiveness of two treatment approaches in improving symptoms and school functioning and increasing health services utilization among adolescents with ADHD. Researchers randomly assigned therapists to deliver one of two treatment approaches for their adolescent clients with ADHD:

• Behavioral treatment alone: Trained therapists delivered an academic support protocol in family and individual sessions that focused on strategies to improve homework management, organization, attendance, and family engagement with school services.
• Behavioral treatment plus support for medication decisions, called integrated treatment: Trained therapists delivered the same behavioral treatment augmented by family-based assistance for making medication decisions. The added protocol focused on education about ADHD, available medications, and family decision making about whether youth should take medication.

The study included 145 adolescents who met the diagnostic criteria for ADHD and were receiving treatment at one of five outpatient behavioral health clinics in the New York City metro area. Of the adolescents, 42% were white, 15% were African American, and 6% were more than one race; 37% were Hispanic. The average adolescent age was 15, and 72% were male.

Researchers interviewed adolescents and their caregivers at baseline and again 3, 6, and 12 months later. Researchers also obtained information on treatment attendance and medication management from medical records.

Clinical researchers, youth and family advocates, clinical site administrators and staff, and former youth with ADHD and their caregivers consulted with the researchers throughout the study.

Results

Compared with adolescents who received behavioral treatment alone, those who received integrated treatment reported greater declines in ADHD inattentive symptoms (95% confidence interval [CI]: -.59, -.03) and fewer delinquent acts (95% CI: -.40, 0). The two treatment approaches did not differ significantly for other primary or any secondary outcomes, including caregiver-reported adolescent medication use.

Limitations

The study took place in five behavioral health clinics in one metro area; results may differ for other clinics or locations. Participating therapists at each site self-selected into the study, so selection bias may have affected findings.

Conclusions and Relevance

In this study, behavioral treatment augmented by medication decision-making assistance reduced inattentiveness and delinquent acts among adolescents with ADHD more than behavioral treatment alone.

Future Research Needs

Future research could compare the two treatment approaches in other mental health clinics and other geographic locations, and randomly select therapists to participate.

More on this Project  

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

• The reviewers had many comments about how the researchers presented results . They noted that the researchers included so many outcomes that it was difficult to discern which were clinically meaningful. In addition, the researchers mostly reported standardized effect estimates rather than mean differences between groups, making the results more difficult to interpret. The researchers responded by emphasizing the primary outcomes in their narrative and by including estimated mean differences at 12 months in presenting their results. They noted that presenting estimated mean differences for the whole time period was not possible since the differences would vary by time point. However, the researchers primarily added this level of information for outcomes that were statistically significant rather than for all outcomes, as the reviewers asked. The researchers felt that it was important to provide the results for all of the outcome measures but stated that they limited the statistics reported for the nonsignificant measures to save space. In describing the strengths and limitations of the study, the researchers also acknowledged that testing multiple outcomes in multiple domains could open the door to spurious statistical findings. However, they felt that it was important to conduct so many statistical tests in order to better understand the complex impacts of behavioral interventions. The researchers cautioned the reader to be conservative in their interpretation of study results.  
• The reviewers expressed concern about the way that the researchers interpreted the results; it seemed that the report emphasized some results that might not be clinically meaningful, and in other cases emphasized results that showed trends toward statistical significance without actually demonstrating statistical or clinical significance. The researchers revised their abstract, results, and discussion to provide a more balanced presentation of the results. They removed references to statistical trends and put more emphasis on key measures even if they showed no significant differences.
• The reviewers asked about the protocols used, how widespread their use is, and how easy they would be to implement in a typical clinic setting. The researchers emphasized that the two protocols were developed recently, one specifically for this study, and so neither is in widespread use. But the researchers said the protocols were designed for use in a typical clinic setting. This report is the first test of their effectiveness in such a setting.

Conflict of Interest Disclosures

The Conflict of Interest Disclosures for this project will be posted here soon.

Project Details

Principal Investigator

Aaron Hogue, PhD

Project Status

Completed; PCORI Public and Professional Abstracts Posted

Project Title

Randomized Comparison of Evidence-Based Protocols for Adolescents with ADHD in Specialty Care: Behavioral Only Versus Integrated Behavioral and Medication Interventions

Board Approval Date

September 2014

Project End Date

June 2020

Organization

CASAColumbia

Year Awarded

2014

State

New York

Year Completed

2020

Project Type

Research Project

Health Conditions  

Mental/Behavioral Health

ADHD

Addiction/Substance Abuse

Intervention Strategies

Behavioral Interventions
Drug Interventions
Other Clinical Interventions
Shared Decision Making
Other Health Services Interventions
Training and Education Interventions

Populations

Children -- 18 and under
Low Income
Racial/Ethnic Minorities
Urban

Funding Announcement

Assessment of Prevention, Diagnosis, and Treatment Options

Project Budget

$2,151,689

Study Registration Information

HSRP20153240

NCT02420990