| Preparation | Community partnerships:•Stakeholders (e.g., child welfare, behavioral health, attorneys) have vested interest and involvement in improving outcomes for system-impacted youth and families. •Sustainable community partnerships are integral to successful clinical intervention research. | Mesosystem:•Identify key stakeholders from existing university partnerships, federal, state-wide, and local databases, and the youth and families directly. •Incorporate stakeholders as key collaborators in all stages of the research process, ideally from the generation of an unmet clinical need through data analysis and dissemination of findings. •Ensure relevant stakeholders understand the overall goals of the intervention, referral process, and how systems considerations (e.g., family reunification plans, supervision of contact) are being addressed. •Identify ways to promote intervention sustainability after research funding ends. •Incorporate youth, family, and other relevant stakeholder perspectives into iterative adaptation and design of interventions to ensure the approach meets local needs, is acceptable, and is feasible to implement. •When permissible, equitably compensate stakeholders for their time contributing to the research process. When stakeholders cannot accept financial compensation, provide refreshments as a gesture of gratitude for donating their time and expertise. |
| Regulatory approvals:•Some counties require court petitions and/or county behavioral health approval, in addition to university IRB approval. | Macrosystem:
•Spend ample time before study begins researching county-specific requirements for conducting clinical intervention research with system-impacted youth. •If recruiting from multiple counties, create a tracking log of all the counties of interest for recruiting families and their requirements ahead of time. •Ensure university IRB approval is obtained with sufficient time to submit alongside the required court petitions (e.g., several months in advance). •For counties requiring attorney approval to approach youth for informed consent, create attorney consent forms, a visual guide to explain study procedures, and a spreadsheet to track attorney contact information. •Initiate a conversation with each county about the “rights” to all data collected. A research team may need to draft a memorandum of understanding (MOU) or exemption form based on the county's expectations and unique history of data use in research. |
| Study clinicians:
•For brief interventions, partnering with community-based clinicians to deliver study interventions can reduce the number of external providers involved in a youth's care, promote long-term sustainability of the intervention, and increase likelihood stakeholders will make study referrals. •Community-based clinicians have varying experience with manualized interventions and maintaining fidelity in clinical research trials, and numerous competing demands from their primary professional role. | Exosystem:
•Create detailed workflows outlining research protocols relevant to clinicians (e.g., checklist of steps to prepare for a session); record training to facilitate onboarding of new clinicians and allow access to refresher material. •Provide training in flexible delivery of manualized interventions, including balancing of flexibility and fidelity in approach, and any empirically supported approaches necessary to deliver them (e.g., motivational interviewing). •Provide training in use of technology for intervention delivery and ensure clinicians' feel comfortable using any special features (e.g., screen sharing).
Macrosystem:
•Partner with supervisors to support community-based clinicians in incorporating the intervention into their standard care, including outside the research trial if there is already evidence to support the intervention's effectiveness. •Identify whether and how interventions can be billed as part of clinical services when delivered by community-based clinicians to promote long-term use. |
| Consent, Engagement, and Retention | Caregiver Consent:
•Caregiver consent for youth to participate in research is often required, however caregivers in system-impacted families may have had their parental rights terminated. •Caregivers may believe participation in clinical research will impact their ongoing dependency case. | Microsystem:
•During initial eligibility screening, ask caregivers if their parental rights have been terminated for the referred youth. If so, identify legal signing guardian (e.g., supervising social worker, family court presiding judge) prior to consent appointment. •Ensure consent process and recruitment materials make clear that participation in the clinical research trial will not impact their ongoing dependency case or decisions about reunification plan.
Exosystem:
•When appropriate, obtain a waiver of parental consent from the university IRB so youth can consent to research without caregiver consent (i.e., youth 12 years+) |
| Coordination with out-of-home placements:
•Youth in foster care are separated from their caregiver and may be without access to a personal form of communication. •Out-of-home placements have varying restrictions on technology use, including for therapeutic purposes with outside clinicians. | Mesosystem:•Coordinate research and intervention appointments with the caregiver and the youth's placement (e.g., group home, short-term residential treatment program) to ensure youth (and caregiver, when relevant) are present. Coordination with social workers and attorneys may also be necessary for screening and consent appointments. •Communicate with out-of-home placements to coordinate availability of a private space and necessary technology prior to the first appointment and send appointment reminders. |
| Clinical Intervention Accessibility:•System-impacted youth and families have diverse linguistic, cultural, and accessibility needs. •System-impacted youth and families are often separated, preventing access to family-based interventions. | Microsystem:•Conduct pre-intervention session with participants focused on enhancing engagement using motivational interviewing principles and troubleshooting possible barriers to session attendance and participation. •Collect data on cultural relevance/acceptability of intervention and adapt iteratively if indicated.
Exosystem:•Hire enthnoculturally diverse and bilingual/multilingual staff and clinicians. •Budget for translation and/or interpretation services in grants.
Macrosystem:
•Ensure accessibility of intervention materials to youth and families with: •Varying visual and auditory abilities (e.g., verbal discussion of intervention materials, enable auto- and/or live closed captioning during telehealth sessions). •Different linguistic (e.g., Spanish, Arabic, Hmong) and/or cultural (e.g., Latinx) backgrounds. |
| Technology Accessibility:
•Youth in foster care are disproportionately impacted by the digital divide and may not have access to necessary technology to participate in sessions. •Technology literacy can vary for both youth and caregivers. | Microsystem:•Develop a standardized set of questions to assess technology access (e.g., what devices youth and family have available, Wi-Fi access and stability of connection) and privacy considerations prior to beginning clinical intervention sessions; consider providing devices and funds for data plan costs to promote participation, as well as headphones to promote privacy. •Provide instructional resources on how to use technology platforms, in both written and visual (e.g., video) formats and in multiple languages; provide personal tutorials to families, as needed.
Macrosystem:
•Ensure handouts and videos are viewable on small screens (e.g., phone) so large device access is not required to participate. |
| Intervention | Clinical Intervention Relevance:•Youth in foster care experience elevated behavioral health needs (e.g., mental health, substance use), often resulting from complex trauma. •Placement out-of-home disrupts familial relationships, which may have already been strained. | Individual:•Ensure content is trauma-responsive (e.g., providing psychoeducation about the impact of trauma on development). •Focus skill-building on transdiagnostic areas such as emotion regulation; teach skills to both you and caregivers.
Microsystem:•Address maintenance of family connections (when appropriate) within imposed limitations by child welfare system; incorporate communication skill building to improve family relationships. |