Family Navigation to Improve ADHD Treatment Adherence for Minority Children
Family Navigation to Improve ADHD Treatment Adherence for Minority Children
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.
The proposed project involves three phases consistent with the ORBIT model:

 Phase 1a (9 months): The Parent Empowerment Program (PEP) developed by Dr. Hoagwood
 (consultant), has been tested in a diverse population of children and adults with mental
 illnesses, such as anxiety and depression, and has been shown to increase family empowerment,
 access to mental health services, and self-efficacy skills. However, PEP has not focused on
 ADHD care. The investigators will use the PEP program as I2-ART's foundation but specifically
 tailor the intervention to improve adherence to ADHD treatments using findings from the
 empirical literature regarding facilitators and barriers to adherence for African American
 (AA) and Latinx (Lx) youth with ADHD and their families. The investigators will gather
 feedback from the focus groups in Phase 1a to make adaptations to I2-ART and determine the
 most effective ways to deploy I2-ART, which will be needed to implement the intervention
 during Phase 1b. Focus groups participants (N=24) will include 6 clinicians (e.g.,
 psychologists, general pediatricians, and developmental pediatricians), 6 experienced family
 navigators from prior PI and co-mentors' studies (3 Lx, 3 AA), 6 caregivers who are
 experienced with ADHD treatment for their child (3 Lx, 3 AA), and 6 caregivers of
 treatment-naïve children with ADHD (3 Lx, 3 AA). Eight focus groups will be conducted using
 the well-established Morgan & Krueger approach (e.g., group size of 3-6 participants).
 Separate focus groups will be conducted for each stakeholder group and for Spanish-speaking
 participants, including at least one focus group for clinicians, two for family navigators (1
 Lx, 1 AA), and four for caregivers (2 Lx, 2 AA). First, the investigators will gather
 information from caregivers of children with ADHD who are experienced with ADHD treatment
 (Parent Focus Group 1) regarding their receptivity to collaboration with a family navigator
 as well as the most effective ways to introduce family navigator/caregiver dyads to each
 other and support their relationship. Then, the investigators will conduct focus groups with
 clinicians to obtain their perspective on needed PEP adaptations to address barriers to ADHD
 treatment adherence and how to identify patients within their clinical practices who may
 benefit from working with a family navigator. Next, the investigators will hold focus groups
 with family navigators to understand preferences for intervention delivery, including their
 feedback on the use of ADHD shared decision-making tools and animated videos to overview
 session key points with minority families. Feedback from all focus groups will be used to
 modify the I2-ART treatment manual and implementation plans, which will subsequently be
 reviewed by focus groups of caregivers of treatment-naïve children with ADHD (Parent Focus
 Group 2) for additional modifications. Throughout the focus groups, the investigators will
 use feedback to ensure I2-ART's cultural appropriateness. All focus groups will be
 facilitated by the PI and co-mentors experienced with focus groups (Drs. Modi, Crosby and
 Jacquez), and will last 1-2 hours. All sessions will be audio-/video-recorded, field notes
 composed, and sessions transcribed verbatim. The primary deliverable is the design and
 content for the I2-ART intervention, including a draft treatment manual.

 Phase 1b (12 months): Four family navigators (2 Lx, 2 AA) will receive I2-ART training, and
 then will implement I2-ART with 2-3 culturally matched caregivers each (n=8-12). Feasibility,
 acceptability, and satisfaction with I2-ART will be assessed after intervention
 implementation. The investigators will make modifications to the I2-ART treatment manual
 based upon family navigator and caregiver feedback. Based on the PEP 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). The family
 navigators' I2-ART training will include these 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. Following training, the family
 navigators will implement the 3-month I2-ART intervention with the caregivers, including a
 2-hour face-to-face meeting (session 1), at least three monthly in-person meetings (sessions
 2, 3, and 4), and intermittent contact between in-person meetings by phone calls, texts or
 emails, as determined by the family navigator-caregiver dyad. Family navigators will meet
 weekly with research staff for supervision and case review. Family navigators and caregivers
 will complete questionnaires at baseline (B), after session 1 (Time 1), after session 2 (Time
 2), after session 3 (Time 3), and immediately post-intervention (Time 4), and 3 months
 post-intervention (Time 5). In addition, the PI will interview the family navigators and
 caregivers to gain a more detailed understanding of their I2-ART experiences. After Phase 1b
 completion, the investigators will modify I2-ART as needed.

 Phase 2 (24 months): Using a 2-wave approach, the investigators will evaluate the preliminary
 effectiveness of the revised I2-ART intervention, compared to a "usual care" control
 condition, on ADHD treatment adherence (e.g., initiation, implementation, and discontinuation
 of ADHD medication and/or behavioral treatment) in minority children (Lx, AA) with ADHD. Four
 family navigators (2 Lx, 2 AA) will implement the I2-ART treatment manual in 2 waves:

 Wave 1 (12 months): Thirty caregivers (15 Lx, 15 AA) will be randomly assigned to the
 intervention group (n=20; 10Lx, 10AA) or "usual care" control group (n=10; 5Lx, 5AA). A
 research liaison at each recruitment site will request caregivers' permission for research
 staff to contact potential participants. Research staff will phone these families, and then
 meet face-to-face with those interested in study participation for informed consent. After
 enrollment, primary caregivers from both groups will meet with research staff to complete
 demographic and baseline measures (B). Then, for the intervention group, the family
 navigators will implement I2-ART for 3 months (including a 2-hour face-to-face meeting with
 the caregivers, at least three monthly in-person meetings, and intermittent contact between
 in-person meetings by phone calls, texts or emails). Family navigators will also meet weekly
 with research staff for supervision and case review. Caregivers in the control group will
 receive "usual care." In addition to completing the baseline surveys, family navigators and
 caregivers from both the intervention and control groups will complete questionnaires at Time
 4 (immediately post-I2-ART for the intervention group) and Time 5 (3-months post-I2-ART for
 the intervention group).

 Wave 2 (12 months): Thirty caregivers (15 Lx, 15 AA) will be randomly assigned to the
 intervention group (n=20; 10Lx, 10AA) or "usual care" control group (n=10; 5Lx, 5AA), and
 will use the same procedures as described for Wave 1.

 Treatment fidelity will be measured through self-report from family navigators and
 caregivers, as well as through research staff assessment. For self-report, family navigators
 and caregivers will complete questionnaires to indicate whether they implemented/received
 identified intervention components. In addition, the investigators will audio record all
 family navigator/caregiver sessions (n=48 for Phase 1b, n=240 for Phase 2); then, the
 investigators will code 10% of the Phase 1b sessions (n=4) and 20% of the Phase 2 sessions
 (n=48) for fidelity. As with prior mentors' projects (Drs. Epstein and Froehlich),4,5 two
 independent coders (PI and research coordinator) will be trained and calibrated on the coding
 scheme and Noldus® software until reaching 90% reliability. The investigators will double
 code half of the coded sessions and will compute intraclass correlation coefficients to
 determine reliability of the fidelity coding. In addition, to ensure uniformity of
 intervention delivery, the investigators will develop an animated video using Vyond (an
 animated software tool) to provide an overview of core concepts and key points for each
 family navigator/caregiver session. This animated video overview of each session's contents
 will be viewed jointly by the family navigator and caregiver, and used as a springboard for
 discussion.
1. Clinicians.

 Inclusion Criteria:

 -  Currently providing care for children with ADHD as psychologists, general
 pediatricians, or developmental pediatricians.

 -  > 18 years old.

 -  Any race/ethnicity.

 Exclusion Criteria:

 * Unable to read/speak either English or Spanish.

 2. Family navigators.

 Inclusion Criteria:

 -  Having experience working as family navigator and/or community health worker.

 -  Latinx (Lx) or African American (AA).

 -  > 18 years old.

 Exclusion Criteria:

 * Unable to read/speak either English or Spanish.

 3. Caregivers.

 Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 * Unable to read/speak either English or Spanish.