Family Navigation to Improve ADHD Treatment Adherence for Minority Children

NCT04591951 | Active Not Recruiting

• 1 other identifier: 1K23MH125138-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

ADHD is the most common pediatric neurodevelopmental disorder and is associated with significant long-term impairments. Current guidelines recommend stimulant medication and/or behavioral therapy as first-line treatments for ADHD. Despite evidence that consistent treatment is important for effectively managing ADHD symptoms, treatment adherence remains suboptimal and is especially problematic among minority children. Hypothesized reasons for racial/ethnic disparities in ADHD treatment include uncertainties about medication efficacy and side effects, distrust of the health care system, and decreased access to mental health services. This study aims to develop and test the I2-ART intervention to improve treatment adherence in minority (Latinx and African American) children with ADHD. The proposed study involves three ORBIT phases: During phase 1a, the investigators will conduct focus groups with key stakeholders (i.e., caregivers, clinicians, and family navigators, n=24) to identify and develop I2-ART's basic elements. Next, during phase 1b, the investigators will train four family navigators to implement I2-ART with caregivers of treatment-naïve children with ADHD (n=8-12) in order to determine feasibility and acceptability. In phase 2, the investigators will use phase 1b findings to modify I2-ART as needed, and then will evaluate the preliminary efficacy of the revised I2-ART (n=40), compared to the "usual care" control condition (n=20), on ADHD treatment adherence. The preliminary data collected during the proposed study will inform a subsequent R01 randomized controlled trial to examine I2-ART efficacy.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Treatment adherence; Family navigation; Latinx; African American

Outcome Measures

Primary Outcomes (21)

• Number of Intervention Sessions

  The family navigators will record the number of sessions attended by caregivers.

  3 months after intervention, up to 6 months

• Length of Intervention Sessions

  The family navigators will record the length of sessions attended by caregivers.

  3 months after intervention, up to 6 months

• Satisfaction with Intervention Immediately after Intervention

  This is a 7-item Likert scale questionnaire that elicits caregivers' and family navigators' opinions regarding the format, content, length, and convenience of the intervention. Answers ranged from Strongly Agree to Strongly Disagree. Higher score means better outcome (satisfaction).

  Immediately after intervention, up to 3 months

• Satisfaction with Intervention 3 months after Intervention

  This is a 7-item Likert scale questionnaire that elicits caregivers' and family navigators' opinions regarding the format, content, length, and convenience of the intervention. Answers ranged from Strongly Agree to Strongly Disagree. Higher score means better outcome (satisfaction).

  3 months after intervention, up to 6 months

• System Usability Scale Immediately after Intervention

  The System Usability Scale is a 10-item Likert scale questionnaire that elicits family navigators' global views of the I2-ART treatment manual's usability. Answers ranged from Strongly Agree to Strongly Disagree. Higher score means better outcome (satisfaction).

  Immediately after intervention, up to 3 months

• System Usability Scale 3 months after Intervention

  The System Usability Scale is a 10-item Likert scale questionnaire that elicits family navigators' global views of the I2-ART treatment manual's usability. Answers ranged from Strongly Agree to Strongly Disagree. Higher score means better usability (outcome).

  3 months after intervention, up to 6 months

• Family Navigator Activities Checklist

  This 27-item checklist will document family navigator-caregiver activities, including emotional support, action planning, information provision, advocacy, and skill development. Higher score means better outcomes (more activities covered by family navigators).

  3 months after intervention, up to 6 months

• Implementation Questionnaire

  The implementation questionnaire will include 10 items recording information about treatment fidelity, time needed for the intervention, enrollment rate, reasons for declining participation, representativeness of the sample, facilitators/barriers to delivering the I2-ART intervention, facilitators/barriers for sustaining intervention after study completion, feedback regarding intervention. Higher score means better implementation (outcome).

  3 months after intervention, up to 6 months

• Change in Services Use in Children and Adolescents from Immediately after Intervention to 3 months after Intervention

  This structured interview assesses use of services for mental health and related issues (e.g., medication and/or behavior therapy).

  Immediately after intervention (up to 3 months) and 3 months after intervention (up to 6 months)

• ADHD medication initiation immediately after intervention

  We will obtain data regarding ADHD medication initiation based on Prescription Drug Monitoring Program records and medical chart review.

  Immediately after intervention, up to 3 months

• ADHD medication initiation 3 months after intervention

  We will obtain data regarding ADHD medication initiation based on Prescription Drug Monitoring Program records and medical chart review.

  3 months after intervention, up to 6 months

• Percent of days covered with ADHD medication immediately after intervention

  We will obtain data regarding percent of days covered with medication once initiated based on Prescription Drug Monitoring Program records.

  Immediately after intervention, up to 3 months

• Percent of days covered with ADHD medication 3 months after intervention

  We will obtain data regarding percent of days covered with medication once initiated based on Prescription Drug Monitoring Program records.

  3 months after intervention, up to 6 months

• Discontinuation of ADHD medication immediately after intervention

  We will obtain data regarding discontinuation of medication once initiated based on Prescription Drug Monitoring Program records and medical chart review.

  Immediately after intervention, up to 3 months

• Discontinuation of ADHD medication 3 months after intervention

  We will obtain data regarding discontinuation of medication once initiated based on Prescription Drug Monitoring Program records and medical chart review.

  3 months after intervention, up to 6 months

• Behavior Therapy Initiation immediately after intervention

  Through medical chart review, we will obtain data regarding initiation of behavior therapy when recommended by clinician.

  Immediately after intervention, up to 3 months

• Behavior Therapy Initiation 3 months after intervention

  Through medical chart review, we will obtain data regarding initiation of behavior therapy when recommended by clinician.

  3 months after intervention, up to 6 months

• Number of Behavior Therapy Visits immediately after intervention

  We will obtain data regarding the number of behavior therapy visits attended by family through medical chart review.

  Immediately after intervention, up to 3 months

• Number of Behavior Therapy Visits 3 months after intervention

  We will obtain data regarding the number of behavior therapy visits attended by family through medical chart review.

  3 months after intervention, up to 6 months

• Behavior Therapy Disengagement immediately after intervention

  We will obtain data regarding behavior therapy disengagement through medical chart review.

  Immediately after intervention, up to 3 months

• Behavior Therapy Disengagement 3 months after intervention

  We will obtain data regarding behavior therapy disengagement through medical chart review.

  3 months after intervention, up to 6 months

Secondary Outcomes (1)

• Change in Vanderbilt ADHD Parent Report Scale Scores from baseline to 3 months after intervention

  Baseline and 3 months after intervention

Other Outcomes (13)

• Working Alliance Inventory

  Baseline, after first session (up to 1 week), after intervention session (up to 1 month), after third session (up to 2 months), immediately after intervention (up to 3 months), 3 months after intervention (up to 6 months)

• Family Empowerment Scale

  Baseline, after first session (up to 1 week), after intervention session (up to 1 month), after third session (up to 2 months), immediately after intervention (up to 3 months), 3 months after intervention (up to 6 months)

• Collaborative Skills Questionnaire

  Baseline, immediately after intervention (up to 3 months), 3 months after intervention (up to 6 months)

Study Arms (2)

I2-ART Group

ACTIVE COMPARATOR

I2-ART intervention will be modeled based on the Parent Empowerment Program model. It will use methods of adult learning, direct instruction to share knowledge or techniques for practice, group support, modeling, vicarious learning, and practice opportunities (i.e., role rehearsals). I2-ART training includes 40 hours of didactic and interactive sessions (10 sessions of 4 hours each) covering the following areas: 1) conceptual framework, 2) listening, engagement, and boundary-setting skills; 3) ADHD psychoeducation (e.g., diagnosis, treatment, shared decision-making tools), and 4) service options. The caregivers in the I2-ART group will receive the intervention for 3 months. The I2-ART will be implemented by the family navigators and will include a 2-hour face-to-face meeting, at least three monthly in-person meetings, and intermittent contact between in-person meetings by phone calls, texts or emails, as determined by the family navigator-caregiver dyad.

Behavioral: I2-ART

Control Group

PLACEBO COMPARATOR

The caregivers in the control group will receive "usual care."

Other: Usual care

Interventions

I2-ART BEHAVIORAL

Based on the Parent Empowerment Program model, I2-ART will use methods of adult learning, direct instruction to share knowledge or techniques for practice, modeling, vicarious learning, and practice opportunities (i.e., role rehearsals). The research team will provide the family navigators with 3 months of I2-ART training, including 40 hours of didactic and interactive sessions (10 sessions of 4 hours each). Following training, the family navigators will implement the 3-month I2-ART intervention with the caregivers, including a 2-hour face-to-face meeting, at least three monthly in-person meetings, and intermittent contact between in-person meetings by phone calls, texts or emails, as determined by the family navigator-caregiver dyad.

I2-ART Group

Usual care OTHER

Care as usual

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently providing care for children with ADHD as psychologists, general pediatricians, or developmental pediatricians.
• \> 18 years old.
• Any race/ethnicity.

You may not qualify if:

• \* Unable to read/speak either English or Spanish.
• Family navigators.
• Having experience working as family navigator and/or community health worker.
• Latinx (Lx) or African American (AA).
• \> 18 years old.
• \* Unable to read/speak either English or Spanish.
• Caregivers.
• Phase 1a: current or former caregiver of a child with ADHD, with and without experience with ADHD treatment.
• Phases 1b and 2: current caregiver of a child (aged 7-11 years) with ADHD who is ADHD treatment-naïve at study enrollment.
• Lx or AA.
• \> 18 years old.
• \* Unable to read/speak either English or Spanish.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Kelly Kamimura-Nishimura, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 19, 2020
• Study Start: May 14, 2021
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)