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.
