Clinical trial NCT04591951: Family Navigation to Improve ADHD Treatment Adherence for Minority Children
Official title: A Family Navigator Intervention to Improve ADHD- Related Treatment Adherence (I2-ART) for Minority Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Treatment adherence
Family navigation
Latinx
African American
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Intervention Sessions
timeFrame: 3 months after intervention, up to 6 months
measure: Length of Intervention Sessions
timeFrame: 3 months after intervention, up to 6 months
measure: Satisfaction with Intervention Immediately after Intervention
timeFrame: Immediately after intervention, up to 3 months
measure: Satisfaction with Intervention 3 months after Intervention
timeFrame: 3 months after intervention, up to 6 months
measure: System Usability Scale Immediately after Intervention
timeFrame: Immediately after intervention, up to 3 months
measure: System Usability Scale 3 months after Intervention
timeFrame: 3 months after intervention, up to 6 months
measure: Family Navigator Activities Checklist
timeFrame: 3 months after intervention, up to 6 months
measure: Implementation Questionnaire
timeFrame: 3 months after intervention, up to 6 months
measure: Change in Services Use in Children and Adolescents from Immediately after Intervention to 3 months after Intervention
timeFrame: Immediately after intervention (up to 3 months) and 3 months after intervention (up to 6 months)
measure: ADHD medication initiation immediately after intervention
timeFrame: Immediately after intervention, up to 3 months
measure: ADHD medication initiation 3 months after intervention
timeFrame: 3 months after intervention, up to 6 months
measure: Percent of days covered with ADHD medication immediately after intervention
timeFrame: Immediately after intervention, up to 3 months
measure: Percent of days covered with ADHD medication 3 months after intervention
timeFrame: 3 months after intervention, up to 6 months
measure: Discontinuation of ADHD medication immediately after intervention
timeFrame: Immediately after intervention, up to 3 months
measure: Discontinuation of ADHD medication 3 months after intervention
timeFrame: 3 months after intervention, up to 6 months
measure: Behavior Therapy Initiation immediately after intervention
timeFrame: Immediately after intervention, up to 3 months
measure: Behavior Therapy Initiation 3 months after intervention
timeFrame: 3 months after intervention, up to 6 months
measure: Number of Behavior Therapy Visits immediately after intervention
timeFrame: Immediately after intervention, up to 3 months
measure: Number of Behavior Therapy Visits 3 months after intervention
timeFrame: 3 months after intervention, up to 6 months
measure: Behavior Therapy Disengagement immediately after intervention
timeFrame: Immediately after intervention, up to 3 months
measure: Behavior Therapy Disengagement 3 months after intervention
timeFrame: 3 months after intervention, up to 6 months
Secondary outcomes:
measure: Change in Vanderbilt ADHD Parent Report Scale Scores from baseline to 3 months after intervention
timeFrame: Baseline and 3 months after intervention
Other outcomes:
measure: Working Alliance Inventory
timeFrame: 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)
measure: Family Empowerment Scale
timeFrame: 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)
measure: Collaborative Skills Questionnaire
timeFrame: Baseline, immediately after intervention (up to 3 months), 3 months after intervention (up to 6 months)
measure: Vanderbilt Mental Health Services Efficacy
timeFrame: Baseline, immediately after intervention (up to 3 months), 3 months after intervention (up to 6 months)
measure: Brief Illness Perceptions Questionnaire
timeFrame: 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)
measure: Beliefs about Medicines Questionnaire
timeFrame: Baseline, immediately after intervention (up to 3 months), 3 months after intervention (up to 6 months)
measure: Decisional Conflict Scale
timeFrame: Baseline, immediately after intervention (up to 3 months), 3 months after intervention (up to 6 months)
measure: Participants' Age
timeFrame: Baseline
measure: Participants' Race and Ethnicity
timeFrame: Baseline
measure: Participants' Employment Status
timeFrame: Baseline
measure: Caregivers' Income
timeFrame: Baseline
measure: Caregivers' Educational Level
timeFrame: Baseline
measure: Caregivers' Marital Status
timeFrame: Baseline
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Kelly Kamimura-Nishimura, MD
role: PRINCIPAL_INVESTIGATOR
References: