Behavior Therapy for ADHD in Primary Care

(PASS Trial)

Overseen By Jaclyn Cacia, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Autism, Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 44

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether integrating behavior therapy into regular doctor visits can improve treatment for children with ADHD from low-income families. Children will either participate in a special program called PASS (Partnering to Achieve School Success), which includes up to 12 therapy sessions over 16 weeks, or continue with standard treatment guided by the American Academy of Pediatrics. The goal is to determine if this approach improves access to effective ADHD care for underserved children. Children aged 5-11 with ADHD who are already receiving care at certain Philadelphia locations and come from low-income families may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative ADHD treatment strategies for underserved communities.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this behavior therapy is safe for children with ADHD?

Research has shown that behavioral therapies like the Partnering to Achieve School Success (PASS) program are generally safe and well-received. These therapies typically avoid harmful side effects by focusing on teaching skills and strategies rather than using medication.

PASS is a personalized behavior therapy for children with ADHD, employing proven techniques effective in past research. This therapy includes up to 12 sessions with a behavioral health provider, tailored to each family's goals and values.

Because PASS does not involve medication, it avoids the common side effects associated with ADHD drugs. Instead, PASS helps children and their families learn positive ways to manage symptoms and improve behavior.

In summary, PASS is considered safe, with no reported negative effects in previous studies. It emphasizes changing behavior and increasing family involvement, making it a low-risk option for managing ADHD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Partnering to Achieve School Success (PASS) program because it offers a personalized and enhanced approach to behavior therapy for ADHD. Unlike standard treatments that might rely heavily on medication or general behavioral strategies, PASS tailors its sessions to align with each family's specific goals and values, enhancing family engagement and collaboration. This individualized attention, combined with team-based care and high-quality therapy, sets PASS apart by potentially improving both the effectiveness of treatment and the family's experience in managing ADHD.

What evidence suggests that this trial's treatments could be effective for ADHD?

Studies have shown that the Partnering to Achieve School Success (PASS) program, a treatment option in this trial, benefits children with ADHD, especially in primary care settings. Research indicates that enhanced behavior therapy, such as PASS, helps reduce disparities in ADHD treatment for underserved families. Early results suggest that the PASS program improves family involvement and provides high-quality therapy tailored to each child's needs. The program includes up to 12 personalized sessions with a behavioral health provider, focusing on goals important to the caregiver. This approach can improve outcomes by fostering teamwork and consistent care. ^{1 2 3 5 6}

Who Is on the Research Team?

Jennifer A Mautone, PhD, NCSP, ABPP

Principal Investigator

Children's Hospital of Philadelphia

Thomas J Power, PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for children aged 5-11 with ADHD from low-income families, primarily served at CHOP Care Network Locations. Eligible participants must have an ADHD diagnosis and significant impairment in daily activities. They should not be receiving other behavioral treatments or have autism, intellectual disabilities, or conditions needing different treatment.

Inclusion Criteria

My child is being treated at one of the six CHOP practices involved in this study.

My child has been diagnosed with ADHD by a healthcare provider.

My child has significant impairment in one or more areas.

Exclusion Criteria

Child is receiving behavioral health services from another provider at the time of recruitment

My child has a serious health condition that needs a different treatment.

Child has a sibling currently enrolled in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive behavior therapy integrated into primary care or treatment as usual for ADHD over 16 weeks

16 weeks

Up to 12 sessions with a behavioral health provider

Follow-up

Participants are monitored for changes in ADHD symptoms, academic progress, and other outcomes

16 weeks

Assessments at 32 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Partnering to Achieve School Success (PASS)
• Treatment as Usual (TAU)
• Treatment as Usual (TAU) plus Family Education

Trial Overview

The study compares two approaches to treating ADHD in underserved kids: the PASS program which integrates behavior therapy into primary care versus the usual treatment informed by AAP guidelines. The goal is to see if integrated care improves access and outcomes for these children.

How Is the Trial Designed?

Group I: Integrated Individualized Behavioral Parent Training Experimental Treatment 1 Intervention

Partnering to Achieve School Success (PASS) is a personalized, enhanced behavioral intervention for ADHD that includes evidence-based behavior therapy strategies and enhancements to promote family engagement in treatment, team-based care, and high quality therapy. Caregivers engage in up to 12 sessions with a behavioral health provider over the course of 16 weeks that are specifically tailored to caregiver goals and values.

Group II: Treatment as Usual Active Control 1 Intervention

The control condition will be TAU informed by AAP guidelines for managing ADHD and facilitated by electronic practice supports, which have been successfully incorporated into the electronic health record (EHR) to guide primary care providers (PCPs) in implementing ADHD guidelines. At CHOP, PCPs across the primary care network were invited to participate in a distance learning, quality improvement initiative to promote implementation of AAP guidelines, including strategies to educate families about ADHD and evidence-based treatments, engage families in shared decision making, titrate medication, and monitor treatment effects. The six practices participating in this study participated in that project.

Partnering to Achieve School Success (PASS) is already approved in United States for the following indications:

Approved in United States as Partnering to Achieve School Success for:

• Attention Deficit/Hyperactivity Disorder (ADHD) in children

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

The Medication Integration Protocol (MIP) was evaluated in a pilot study with 14 inner-city adolescents, showing improved adherence to treatment protocols and a stronger therapeutic alliance compared to a historical control group of 21 teens.

MIP led to higher rates of psychiatric evaluations and initiation of ADHD medication, indicating its potential effectiveness in promoting medication utilization among adolescents with ADHD in outpatient behavioral care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Evaluation of the Medication Integration Protocol for Adolescents with ADHD in Behavioral Care: Treatment Fidelity and Medication Uptake. Hogue, A., Lichvar, E., Bobek, M.[2021]

Training pediatric primary care providers (PCPs) in stimulant diversion prevention significantly increased their use of patient/family education strategies to prevent medication misuse among adolescents with ADHD, with effects lasting up to 18 months.

The training improved PCPs' knowledge and skills, accounting for nearly half of the increase in education strategy use, although it did not significantly change their approaches to medication management or mental health assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Training on Use of Stimulant Diversion Prevention Strategies by Pediatric Primary Care Providers: Results from a Cluster-Randomized Trial. McGuier, EA., Kolko, DJ., Pedersen, SL., et al.[2023]

In a 16-week study involving 303 adolescents with ADHD and substance use disorders, osmotic-release methylphenidate (OROS-MPH) did not show greater efficacy than placebo in reducing ADHD symptoms or substance use days, indicating it may not be more effective than a placebo in this population.

However, OROS-MPH was well tolerated and showed some modest improvements in secondary outcomes, such as lower parent-reported ADHD symptoms and more negative urine drug screens, suggesting it may have some benefits when used alongside cognitive-behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders. Riggs, PD., Winhusen, T., Davies, RD., et al.[2021]

The study tested two family-based interventions for adolescents with ADHD, finding that the combination of Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA) and Medication Integration Protocol (MIP) led to greater improvements in inattentive symptoms and delinquent behavior over one year compared to CASH-AA alone.

Both treatment protocols were effective in addressing ADHD symptoms and related issues, with non-substance users benefiting from increased treatment attendance, while substance users showed improvements in hyperactive symptoms when only receiving CASH-AA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Academic Training and Medication Decision-Making for Adolescents with ADHD in Usual Care. Hogue, A., Horan Fisher, J., Dauber, S., et al.[2021]

The integration of medication-assisted treatment (MAT) for opioid use disorder into family medicine residency programs allows residents to manage a diverse range of chronic medical comorbidities, enhancing their clinical experience.

In a study of 157 active MAT patients, 66% were managed as primary care patients, with an average of 2.3 chronic comorbidities per patient, highlighting the significant healthcare needs of this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Buprenorphine Treatment Into Family Medicine Resident Clinic. Tiemstra, JD., Walsh, LH.[2021]

Adolescents with ADHD often do not receive adequate treatment, particularly with stimulant medications, which are the first-line therapy for this condition.

The Medication Integration Protocol (MIP) combines three behavioral interventions to enhance medication integration in treatment planning, emphasizing the importance of family involvement and therapist leadership in managing ADHD effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Strategies for Integrating Medication Interventions Into Behavioral Treatment for Adolescent ADHD: The Medication Integration Protocol. Hogue, A., Bobek, M., Tau, GZ., et al.[2020]

Stimulant medication, particularly methylphenidate, is the primary treatment for ADHD among children, with 88% of diagnosed children receiving it, despite concerns about its use.

There is a significant discrepancy in ADHD diagnoses, as only 72% of children diagnosed by physicians met the DSM-III-R criteria based on structured interviews, highlighting the need for more accurate diagnostic practices and greater use of behavioral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulant medication use by primary care physicians in the treatment of attention deficit hyperactivity disorder. Wolraich, ML., Lindgren, S., Stromquist, A., et al.[2015]

A survey of 161 children diagnosed with ADHD revealed that 16% had been approached to sell or trade their prescribed stimulants, indicating a potential risk for misuse among peers.

44% of the children and 37% of schools reported that stimulants were stored unlocked during school hours, highlighting a safety concern regarding the management of these medications in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulant use and the potential for abuse in Wisconsin as reported by school administrators and longitudinally followed children. Musser, CJ., Ahmann, PA., Theye, FW., et al.[2019]

A study involving 18 patients and 14 physicians identified seven key themes of success in medication for opioid use disorder (MOUD), emphasizing that treatment success should include not just sobriety but also improvements in mental health, relationships, and overall functioning.

Both patients and physicians highlighted the importance of tapering off buprenorphine and reducing stigma, suggesting that a broader perspective on treatment outcomes is essential for evaluating MOUD programs in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is success in treatment for opioid use disorder? Perspectives of physicians and patients in primary care settings. Hooker, SA., Sherman, MD., Lonergan-Cullum, M., et al.[2022]

A community-based trial involving 278 adolescents showed that behavior therapy (STAND) for ADHD did not significantly outperform usual care overall, but it was more effective in reducing conduct problems when delivered by licensed clinicians.

The study highlights the importance of using licensed professionals for ADHD treatment in community settings to enhance effectiveness, particularly for adolescents with comorbid conduct issues, and suggests addressing barriers for unlicensed clinicians to improve implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Community-Based Trial of Behavior Therapy vs. Usual Care for Adolescent ADHD: Secondary Outcomes and Effects on Comorbidity. Sibley, MH., Graziano, PA., Coxe, SJ., et al.[2023]

Buprenorphine, particularly in combination with naloxone, is an effective alternative to methadone for treating opioid addiction, offering a more accessible option for patients in primary care settings due to fewer regulatory restrictions.

The integration of medication-assisted treatment with behavioral counseling can enhance recovery outcomes for opioid-dependent individuals, especially among racial and ethnic minorities who may prefer primary care over specialty mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid addiction and abuse in primary care practice: a comparison of methadone and buprenorphine as treatment options. Bonhomme, J., Shim, RS., Gooden, R., et al.[2021]

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