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

300 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Partnering to Achieve School Success (PASS) for ADHD?

The Medication Integration Protocol (MIP), a family-based intervention for ADHD, showed greater completion of psychiatric evaluations and initiation of ADHD medication compared to a control group, suggesting that family-centered approaches like PASS may enhance treatment engagement and outcomes. ^{1 2 3 4 5}

Is behavior therapy for ADHD safe for humans?

The studies reviewed focus on integrating medication with behavioral therapy for ADHD, highlighting the importance of family involvement and education. While specific safety data for behavior therapy alone isn't detailed, the integration of medication and therapy is generally considered safe when managed properly, with attention to medication management and family decision-making. ^{3 6 7 8 9}

How does the PASS treatment for ADHD differ from other treatments?

The PASS treatment for ADHD is unique because it combines behavior therapy with family education, aiming to improve school success by involving both the child and their family in the treatment process. This approach is different from standard treatments that often focus solely on medication or individual therapy. ^{4 7 8 10 11}

What is the purpose of this trial?

This trial tests a special behavior therapy provided in the doctor's office for low-income children with ADHD. The therapy works closely with the child's regular doctor to help improve behavior, school performance, and relationships.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

What is success in treatment for opioid use disorder? Perspectives of physicians and patients in primary care settings. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Integrating Buprenorphine Treatment Into Family Medicine Resident Clinic. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Pilot Evaluation of the Medication Integration Protocol for Adolescents with ADHD in Behavioral Care: Treatment Fidelity and Medication Uptake. [2021]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Opioid addiction and abuse in primary care practice: a comparison of methadone and buprenorphine as treatment options. [2021]

6. United States 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical Strategies for Integrating Medication Interventions Into Behavioral Treatment for Adolescent ADHD: The Medication Integration Protocol. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Randomized Trial of Academic Training and Medication Decision-Making for Adolescents with ADHD in Usual Care. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Stimulant use and the potential for abuse in Wisconsin as reported by school administrators and longitudinally followed children. [2019]

10. England 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Stimulant medication use by primary care physicians in the treatment of attention deficit hyperactivity disorder. [2015]