Family Navigation to Improve ADHD Treatment Adherence for Minority Children

Not Applicable

Recruiting

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Other: Usual care; Behavioral: I2-ART

• Registration Number: NCT04591951
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-19
• Study Start: 2021-05-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Usual care	The caregivers in the control group will receive "usual care."
I2-ART Group	I2-ART	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.

Primary Outcome Measures

Name	Time	Method
System Usability Scale 3 months after Intervention	3 months after intervention, up to 6 months	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).
Satisfaction with Intervention 3 months after Intervention	3 months after intervention, up to 6 months	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).
System Usability Scale Immediately after Intervention	Immediately after intervention, up to 3 months	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).
Percent of days covered with ADHD medication 3 months after intervention	3 months after intervention, up to 6 months	We will obtain data regarding percent of days covered with medication once initiated based on Prescription Drug Monitoring Program records.
Discontinuation of ADHD medication immediately after intervention	Immediately after intervention, up to 3 months	We will obtain data regarding discontinuation of medication once initiated based on Prescription Drug Monitoring Program records and medical chart review.
Number of Behavior Therapy Visits immediately after intervention	Immediately after intervention, up to 3 months	We will obtain data regarding the number of behavior therapy visits attended by family through medical chart review.
Number of Intervention Sessions	3 months after intervention, up to 6 months	The family navigators will record the number of sessions attended by caregivers.
Length of Intervention Sessions	3 months after intervention, up to 6 months	The family navigators will record the length of sessions attended by caregivers.
Family Navigator Activities Checklist	3 months after intervention, up to 6 months	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).
Change in Services Use in Children and Adolescents from Immediately after Intervention to 3 months after Intervention	Immediately after intervention (up to 3 months) and 3 months after intervention (up to 6 months)	This structured interview assesses use of services for mental health and related issues (e.g., medication and/or behavior therapy).
Satisfaction with Intervention Immediately after Intervention	Immediately after intervention, up to 3 months	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).
Implementation Questionnaire	3 months after intervention, up to 6 months	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).
ADHD medication initiation immediately after intervention	Immediately after intervention, up to 3 months	We will obtain data regarding ADHD medication initiation based on Prescription Drug Monitoring Program records and medical chart review.
ADHD medication initiation 3 months after intervention	3 months after intervention, up to 6 months	We will obtain data regarding ADHD medication initiation based on Prescription Drug Monitoring Program records and medical chart review.
Percent of days covered with ADHD medication immediately after intervention	Immediately after intervention, up to 3 months	We will obtain data regarding percent of days covered with medication once initiated based on Prescription Drug Monitoring Program records.
Discontinuation of ADHD medication 3 months after intervention	3 months after intervention, up to 6 months	We will obtain data regarding discontinuation of medication once initiated based on Prescription Drug Monitoring Program records and medical chart review.
Behavior Therapy Initiation immediately after intervention	Immediately after intervention, up to 3 months	Through medical chart review, we will obtain data regarding initiation of behavior therapy when recommended by clinician.
Behavior Therapy Initiation 3 months after intervention	3 months after intervention, up to 6 months	Through medical chart review, we will obtain data regarding initiation of behavior therapy when recommended by clinician.
Number of Behavior Therapy Visits 3 months after intervention	3 months after intervention, up to 6 months	We will obtain data regarding the number of behavior therapy visits attended by family through medical chart review.
Behavior Therapy Disengagement immediately after intervention	Immediately after intervention, up to 3 months	We will obtain data regarding behavior therapy disengagement through medical chart review.
Behavior Therapy Disengagement 3 months after intervention	3 months after intervention, up to 6 months	We will obtain data regarding behavior therapy disengagement through medical chart review.

Secondary Outcome Measures

Name	Time	Method
Change in Vanderbilt ADHD Parent Report Scale Scores from baseline to 3 months after intervention	Baseline and 3 months after intervention	The Vanderbilt ADHD Parent Report Scale is a 25-item scale that assess ADHD symptoms, including 9 attention items and 9 hyperactivity/impulsive items. Answers ranged from (0) Never to (3) Very Often. Summary scores for the 2 ADHD symptom domains are created by summing the 9 inattention and the 9 hyperactivity/impulsivity items.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States