ADHDPASSNCT04082234
Reducing Disparities in Behavioral Health Treatment for Children in Primary Care
A study testing Partnering to Achieve School Success (PASS) and Treatment as Usual (TAU) in people with ADHD, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of this study is to address a decisional dilemma faced by health system officials, policy makers, and clinical leaders: "Does it make sense to integrate behavior therapy into primary care practice to treat children with ADHD from low-income settings? More specifically, does integrated care improve access… Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Partnering to Achieve School Success (PASS) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of 5 and 11 years (as reported in EHR at the time of referral to the study team)
- Children receiving care in one of the seven targeted CHOP practices for this study
- Children with an existing diagnosis of ADHD (as indicated by the referring primary care provider or behavioral health provider and/or EHR)
- Children with one or more areas of impairment (score of 3 or 4 on scale ranging from 1 to 4)
- Evidence that child may be in a family of low-income status, as indicated by child eligibility for Medicaid or Children's Health Insurance Program (CHIP) OR child living in a census tract or census block with median income at or below two times the federal poverty level
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Who cannot join
- Child has autism spectrum disorder
- Child has an intellectual disability
- Child has a comorbid condition that is a major clinical concern and requires an alternative form of treatment
- Child is receiving behavioral health services from another provider at the time of recruitment
- Child has a sibling currently enrolled in the study
- Child has received Healthy Minds, Healthy Kids (CHOP's Integrated Behavioral Health Service) in the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to address a decisional dilemma faced by health system officials, policy makers, and clinical leaders: "Does it make sense to integrate behavior therapy into primary care practice to treat children with ADHD from low-income settings? More specifically, does integrated care improve access to services and patient-centered outcomes for underserved children with ADHD?" Participants will be randomly assigned to one of two groups: Behavior therapy integrated into primary care (Partnering to Achieve School Success; PASS program) to treatment as usual (TAU) informed by American Academy of Pediatrics (AAP) guidelines for ADHD practice and facilitated by electronic practice supports." Participants will be 300 children (ages 5-11) with ADHD and their caregivers served at Children's Hospital of Philadelphia Care Network Locations (primary care offices). Participants are drawn from primary care locations that serve primarily low-income and racial/ethnic minority population.
Read the detailed description
Context: Families of children with attention-deficit/hyperactivity disorder (ADHD) often have difficulty getting access to behavior therapy for their children. This project focuses on children and families of low-income, racial/ethnic minority background, who have particular difficulty getting access to behavior therapy. This study will compare enhanced behavior therapy integrated into primary care (known as Partnering to Achieve School Success [PASS]) to treatment as usual (TAU) informed by American Academy of Pediatrics (AAP) guidelines for the treatment of ADHD. In this study, behavior therapy will include components to address the unique needs of low-income families of minority status.
Objectives: This project is designed to improve family use of services for ADHD; improve children's academic achievement, behavioral compliance, interpersonal relationships, and life satisfaction; and reduce ADHD symptoms.
Study Design: The study is a randomized controlled trial.
Setting/Participants: The study is being conducted in seven CHOP primary care practices serving a high percentage of families of low-income, racial/ethnic minority status. Participants will be children ages 5 to 11 with ADHD. Children will be randomly assigned to PASS or TAU, with 150 per group.
Study Interventions and Measures: PASS is a behavioral intervention for childhood ADHD that includes behavior therapy strategies and enhancements to promote family engagement in treatment, team-based care, and high-quality therapy. PASS uses a fully integrated service model that includes regular collaboration between the PASS provider and primary care provider (PCP). The primary outcomes are patient-centered outcomes pertaining to child academic achievement, behavior compliance, interpersonal relationships, and life satisfaction, as assessed by parent/legal guardian (or caregiver), and child rating. Secondary outcomes are informant ratings of ADHD symptoms.
- Conditions
- ADHD
- Being tested
- Partnering to Achieve School Success (PASS), Treatment as Usual (TAU)
- Keywords
- Behavior Therapy, Integrated Primary Care, Reducing Disparities
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partnering to Achieve School Success (PASS)Behavioural
Individualized parent training program delivered at child's primary care provider office. Providers use engagement and motivation strategies during each session to reinforce help-seeking behavior and family empowerment, and encourage family adherence to recommended strategies. Also includes regular communication between pass provider and PCP and development of a problem-solving partnership between parents and teachers to address school problems. Families are supported in between sessions by a Community Health Partner who contacts families to promote attendance and implementation of strategies and assist in resolving barriers to treatment. The intervention is up to 12 sessions over the course of 16 weeks depending on caregiver goals.
Caregivers will work with their primary care physician to address their child's ADHD. Primary care physicians have been trained in and informed of American Academy of Pediatrics guidelines for treating ADHD. Treatment may include strategies to educate families about ADHD and evidence-based treatments, refer families to community mental health agencies that deliver evidence-based behavioral programming (other than PASS), engage families in shared decision making, titrate medication, and monitor treatment effects. In addition, families will have access to integrated behavioral health services that are typically offered at their child's primary care office.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Individualized Behavioral Parent Training | Experimental | 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. Receives: Behavioral: Partnering to Achieve School Success (PASS) |
| Treatment as Usual | Active comparator | 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Homework Performance
The Inattention/Task Avoidance factor of the Homework Problem Checklist (HPC) will be used as a parent-report measure of academic performance. This 12-item scale has strong psychometric properties and is responsive to family-school intervention programs.
Measured: Baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Behavior Compliance
Behavior compliance will be determined by assessing the severity of disruptive behavior using the eight items pertaining to oppositional-defiant disorder from the Vanderbilt parent scale and four items pertaining to oppositional-defiant disorder (ODD) from the Vanderbilt teacher scale. Both parents (primary outcome) and teachers (secondary outcome) will complete this measure. The psychometric properties of parent and teacher reports on this measure have been shown to be adequate.
Measured: Baseline, 8-weeks (mid-treatment; parent only), 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Symptoms of ADHD and Emotional and Behavioral Problems
Severity of ADHD symptoms will be assessed using the Vanderbilt Scales. This measure will be completed by parents and teachers. Parent and teacher ratings of ADHD symptoms have been demonstrated to have excellent psychometric properties and to be sensitive to change in response to treatment. A total symptom score will be used in this study. A child self-report measure of ADHD symptoms will not be included because children with ADHD have been shown to substantially overestimate their competence with regard to paying attention and regulating their behavior. All 18 ADHD symptom items will be completed at Baseline and all 9 ADHD Inattention items and 3 ADHD Hyperactivity/Impulsivity items will be administered at post-treatment and follow-up.
Measured: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Peer Relationships
The Patient Reported Outcomes Measurement Information System (PROMIS) peer relationships scales will be used to assess child relationships with their peers. The child-report version consists of 8 items and the parent-report measure has 7 items. These measures assess the quality of children's relationships with peers including the degree of peer acceptance. The scales have been shown to produce scores that are both reliable and valid based on analyses using item response theory.
Measured: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Life Satisfaction
The PROMIS life satisfaction scale consists of a 4-item child-report measure and a 4-item parent-report measure. It assesses children's and parents' evaluations of the quality of the child's life. Using analyses based in item response theory, these scales have been shown to be reliable with a wide range of life satisfaction levels [from 2.5 standard deviations (SDs) below the mean to 1 SD above the mean].
Measured: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Service Use
Service use for emotional and behavioral problems will be measured via a service use measure adapted for this study designed to gather information on the child's use of services to treat ADHD. In this study, we will collect data on service utilization in outpatient mental health settings and school settings, and treatment with medication.
Measured: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Secondary outcomes (10)
Changes in Parent-Child Relationship
The Parent-Child Relationship Questionnaire (PCRQ) will assess parent perceptions of their parenting practices. Four items from the positive Involvement factor and the full Negative/Ineffective Discipline factor (12 items) are included in the current trial.
Measured: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Family Empowerment
Parent empowerment with regard to their knowledge of how to obtain services for their children will be assessed using the Service System factor of the Family Empowerment Scale. This twelve-item scale has been shown to have adequate reliability (alpha=.87; test-retest=.77) and validity.
Measured: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Perceptions of Team-Based Care
To evaluate parental perceptions of team-based care, a seven-item scale was derived from the Clinician and Group Survey, Version 3.0 of the Consumer Assessment of Healthcare Providers and Systems (CAHPS, https://cahps.ahrq.gov/surveys-guidance/cg/about/index.html). The scale includes four Communication and three Care Coordination items.
Measured: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Parent-Teacher Involvement
Items from the Quality of Parent-Teacher Relationship subscale of the Parent-Teacher Involvement Questionnaire (PTIQ) will be used to evaluate the quality of the family-school relationship. The parent version of the form includes 6 items and the teacher version consists of 5 items. Subscales have been validated in families of youth with ADHD and have demonstrated acceptable internal consistency and validity.
Measured: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Satisfaction with Treatment
Parent satisfaction with PASS will be assessed using modified versions of the Treatment Evaluation Inventory (TEI).
Measured: 16-weeks (post-treatment)
Acceptability of PASS Delivery Modality
Parent/legal guardian/caregiver satisfaction with the modality of PASS delivery (i.e., in-person or telehealth) will be assessed using a novel Acceptability of PASS Delivery Modality measure.
Measured: 16-weeks (post-treatment)
Cultural Humility of Provider
Parent/legal guardian/caregiver perceptions of PASS provider cultural humility will be assessed using a novel Cultural Humility Measure at post-treatment.
Measured: 16-weeks (post-treatment)
Post-Treatment Interview
Parent/legal guardian/caregivers in the PASS condition will be offered the opportunity to complete a one-time, audio-recorded, qualitative interview at the post-treatment assessment timepoint. This interview will include questions related to perceptions of effectiveness, acceptability, feasibility, and usability of the PASS intervention and the Community Health Partner support, as well as the cultural humility of the PASS provider. The interview will be conducted once and take approximately 40 minutes to complete. Caregivers/legal guardians/parents will be asked to participate (i.e., not children or teachers). Caregivers/legal guardians/parents may participate in this interview whether they received any PASS sessions or not, as long as they had been randomized to the PASS condition and have not withdrawn from the study.
Measured: 16-weeks (post-treatment)
Changes in Academic Progress
The Academic Progress Report (APR) is a parent- and teacher-report measure of academic achievement. The APR assesses proficiency in academic subjects relative to standard expectations (1=Well below standard; 3=At standard; 5=Well above standard). The sum of ratings across academic subjects is the unit of analysis. Reliability is acceptable (alpha = .84), and this measure is sensitive to the effect of behavioral treatments.
Measured: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Behavior Compliance
Behavior compliance will be determined by assessing the severity of disruptive behavior using the eight items pertaining to oppositional-defiant disorder from the Vanderbilt parent scale and four items pertaining to oppositional-defiant disorder (ODD) from the Vanderbilt teacher scale. Both parents (primary outcome) and teachers (secondary outcome) will complete this measure. The psychometric properties of parent and teacher reports on this measure have been shown to be adequate.
Measured: Baseline, 8-weeks (mid-treatment; parent only), 16-weeks (post-treatment), 32-weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Nov 2019
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Jennifer A Mautone, PhD, NCSP, ABPP, Principal investigator, Children's Hospital of PhiladelphiaThomas J Power, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082234
- Sponsor's protocol ID
- 19-016315
- Acronym
- PASS
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2019
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per Patient-Centered Outcomes Institute (PCORI) requirements, the Full Data Package will be maintained for at least 7 years after the Final Research Report has been submitted and accepted. The final dataset will be exported from REDCap to Microsoft Excel and commonly used statistical software packages such as Statistical Package for the Social Sciences (SPSS) and Statistical Analysis Software (SAS), as requested by the individuals seeking access to the data. The research team will prepare a codebook to share with the requesting individuals. The codebook will provide information about all of the variables and how the composite variables (e.g. factor scores) were derived.
Publications
Mautone JA, Holdaway A, Chan W, Michel JJ, Guevara JP, Davis A, Desrochers C, Evans E, Gajary Z, Leavy S, Rios D, Tremont KL, Cacia J, Schwartz BS, Jawad AF, Power TJ. 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. BMC Prim Care. 2024 Jun 22;25(1):225. doi: 10.1186/s12875-024-02473-7.
PubMed 38909215
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Disparities in Behavioral Health Treatment for Children in Primary Care
- ClinicalTrials.gov ID
- NCT04082234
- Acronym / sponsor ID
- PASS / 19-016315
- Conditions
- ADHD
- Keywords
- Behavior Therapy, Integrated Primary Care, Reducing Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to address a decisional dilemma faced by health system officials, policy makers, and clinical leaders: "Does it make sense to integrate behavior therapy into primary care practice to treat children with ADHD from low-income settings? More specifically, does integrated care improve access to services and patient-centered outcomes for underserved children with ADHD?" Participants will be randomly assigned to one of two groups: Behavior therapy integrated into primary care (Partnering to Achieve School Success; PASS program) to treatment as usual (TAU) informed by American Academy of Pediatrics (AAP) guidelines for ADHD practice and facilitated by electronic practice supports." Participants will be 300 children (ages 5-11) with ADHD and their caregivers served at Children's Hospital of Philadelphia Care Network Locations (primary care offices). Participants are drawn from primary care locations that serve primarily low-income and racial/ethnic minority population.
Detailed description
Context: Families of children with attention-deficit/hyperactivity disorder (ADHD) often have difficulty getting access to behavior therapy for their children. This project focuses on children and families of low-income, racial/ethnic minority background, who have particular difficulty getting access to behavior therapy. This study will compare enhanced behavior therapy integrated into primary care (known as Partnering to Achieve School Success [PASS]) to treatment as usual (TAU) informed by American Academy of Pediatrics (AAP) guidelines for the treatment of ADHD. In this study, behavior therapy will include components to address the unique needs of low-income families of minority status.
Objectives: This project is designed to improve family use of services for ADHD; improve children's academic achievement, behavioral compliance, interpersonal relationships, and life satisfaction; and reduce ADHD symptoms.
Study Design: The study is a randomized controlled trial.
Setting/Participants: The study is being conducted in seven CHOP primary care practices serving a high percentage of families of low-income, racial/ethnic minority status. Participants will be children ages 5 to 11 with ADHD. Children will be randomly assigned to PASS or TAU, with 150 per group.
Study Interventions and Measures: PASS is a behavioral intervention for childhood ADHD that includes behavior therapy strategies and enhancements to promote family engagement in treatment, team-based care, and high-quality therapy. PASS uses a fully integrated service model that includes regular collaboration between the PASS provider and primary care provider (PCP). The primary outcomes are patient-centered outcomes pertaining to child academic achievement, behavior compliance, interpersonal relationships, and life satisfaction, as assessed by parent/legal guardian (or caregiver), and child rating. Secondary outcomes are informant ratings of ADHD symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Individualized Behavioral Parent Training | Experimental | Behavioral: Partnering to Achieve School Success (PASS)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. |
| Treatment as Usual | Active comparator | Other: Treatment as Usual (TAU)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. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children between the ages of 5 and 11 years (as reported in EHR at the time of referral to the study team)
- Children receiving care in one of the seven targeted CHOP practices for this study
- Children with an existing diagnosis of ADHD (as indicated by the referring primary care provider or behavioral health provider and/or EHR)
- Children with one or more areas of impairment (score of 3 or 4 on scale ranging from 1 to 4)
- Evidence that child may be in a family of low-income status, as indicated by child eligibility for Medicaid or Children's Health Insurance Program (CHIP) OR child living in a census tract or census block with median income at or below two times the federal poverty level
Key exclusion criteria (6 listed)
- Child has autism spectrum disorder
- Child has an intellectual disability
- Child has a comorbid condition that is a major clinical concern and requires an alternative form of treatment
- Child is receiving behavioral health services from another provider at the time of recruitment
- Child has a sibling currently enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partnering to Achieve School Success (PASS)Individualized parent training program delivered at child's primary care provider office. Providers use engagement and motivation strategies during each session to reinforce help-seeking behavior and family empowerment, and encourage family adherence to recommended strategies. Also includes regular communication between pass provider and PCP and development of a problem-solving partnership between parents and teachers to address school problems. Families are supported in between sessions by a Community Health Partner who contacts families to promote attendance and implementation of strategies and assist in resolving barriers to treatment. The intervention is up to 12 sessions over the course of 16 weeks depending on caregiver goals. | Behavioural | Integrated Individualized Behavioral Parent Training |
| Treatment as Usual (TAU)Caregivers will work with their primary care physician to address their child's ADHD. Primary care physicians have been trained in and informed of American Academy of Pediatrics guidelines for treating ADHD. Treatment may include strategies to educate families about ADHD and evidence-based treatments, refer families to community mental health agencies that deliver evidence-based behavioral programming (other than PASS), engage families in shared decision making, titrate medication, and monitor treatment effects. In addition, families will have access to integrated behavioral health services that are typically offered at their child's primary care office. | Other | Treatment as Usual |
Primary outcome
Changes in Homework Performance
Time frame: Baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up)
The Inattention/Task Avoidance factor of the Homework Problem Checklist (HPC) will be used as a parent-report measure of academic performance. This 12-item scale has strong psychometric properties and is responsive to family-school intervention programs.
Changes in Behavior Compliance
Time frame: Baseline, 8-weeks (mid-treatment; parent only), 16-weeks (post-treatment), 32-weeks (follow-up)
Behavior compliance will be determined by assessing the severity of disruptive behavior using the eight items pertaining to oppositional-defiant disorder from the Vanderbilt parent scale and four items pertaining to oppositional-defiant disorder (ODD) from the Vanderbilt teacher scale. Both parents (primary outcome) and teachers (secondary outcome) will complete this measure. The psychometric properties of parent and teacher reports on this measure have been shown to be adequate.
Changes in Symptoms of ADHD and Emotional and Behavioral Problems
Time frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Severity of ADHD symptoms will be assessed using the Vanderbilt Scales. This measure will be completed by parents and teachers. Parent and teacher ratings of ADHD symptoms have been demonstrated to have excellent psychometric properties and to be sensitive to change in response to treatment. A total symptom score will be used in this study. A child self-report measure of ADHD symptoms will not be included because children with ADHD have been shown to substantially overestimate their competence with regard to paying attention and regulating their behavior. All 18 ADHD symptom items will be completed at Baseline and all 9 ADHD Inattention items and 3 ADHD Hyperactivity/Impulsivity items will be administered at post-treatment and follow-up.
Changes in Peer Relationships
Time frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
The Patient Reported Outcomes Measurement Information System (PROMIS) peer relationships scales will be used to assess child relationships with their peers. The child-report version consists of 8 items and the parent-report measure has 7 items. These measures assess the quality of children's relationships with peers including the degree of peer acceptance. The scales have been shown to produce scores that are both reliable and valid based on analyses using item response theory.
Changes in Life Satisfaction
Time frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
The PROMIS life satisfaction scale consists of a 4-item child-report measure and a 4-item parent-report measure. It assesses children's and parents' evaluations of the quality of the child's life. Using analyses based in item response theory, these scales have been shown to be reliable with a wide range of life satisfaction levels [from 2.5 standard deviations (SDs) below the mean to 1 SD above the mean].
Changes in Service Use
Time frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Service use for emotional and behavioral problems will be measured via a service use measure adapted for this study designed to gather information on the child's use of services to treat ADHD. In this study, we will collect data on service utilization in outpatient mental health settings and school settings, and treatment with medication.
10 secondary outcomes
Changes in Parent-Child Relationship
Time frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Family Empowerment
Time frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Perceptions of Team-Based Care
Time frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Parent-Teacher Involvement
Time frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Satisfaction with Treatment
Time frame: 16-weeks (post-treatment)
Acceptability of PASS Delivery Modality
Time frame: 16-weeks (post-treatment)
Cultural Humility of Provider
Time frame: 16-weeks (post-treatment)
Post-Treatment Interview
Time frame: 16-weeks (post-treatment)
Changes in Academic Progress
Time frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Changes in Behavior Compliance
Time frame: Baseline, 8-weeks (mid-treatment; parent only), 16-weeks (post-treatment), 32-weeks (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 38909215Mautone JA, Holdaway A, Chan W, Michel JJ, Guevara JP, Davis A, Desrochers C, Evans E, Gajary Z, Leavy S, Rios D, Tremont KL, Cacia J, Schwartz BS, Jawad AF, Power TJ. 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. BMC Prim Care. 2024 Jun 22;25(1):225. doi: 10.1186/s12875-024-02473-7.
- Individual participant dataSharing planned: Yes. Per Patient-Centered Outcomes Institute (PCORI) requirements, the Full Data Package will be maintained for at least 7 years after the Final Research Report has been submitted and accepted. The final dataset will be exported from REDCap to Microsoft Excel and commonly used statistical software packages such as Statistical Package for the Social Sciences (SPSS) and Statistical Analysis Software (SAS), as requested by the individuals seeking access to the data. The research team will prepare a codebook to share with the requesting individuals. The codebook will provide information about all of the variables and how the composite variables (e.g. factor scores) were derived.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A Mautone, PhD, NCSP, ABPP principal investigator
Children's Hospital of Philadelphia
Thomas J Power, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partnering to Achieve School Success (PASS) and Treatment as Usual (TAU) in people with ADHD, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Homework Performance (time frame: Baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.