Study Navigator Contact Form🔗

Name	Study Navigator Contact Form
Concatenated Data	study_navigator/
Construct	Recruitment/Retention
Study Visits	Filled out by the Study Navigator during and/or between study visits.
Type	In-person/Remote Interview
Quality Control	This form is under development for HBCD. Data was collected with guidance using the HBCD Study Navigation Contact Form Guide. Data review and cleaning has occurred 3 times (September 2024, February 2025, and November 2025). Minor updates to the form and the form guide were completed in September 2024 and October 2025.

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Instrument Details🔗

The Study Navigator Contact Form captures visit-specific information when participant support is provided, provided as concatenated data within the HBCD data release.

Recruitment and retention in studies involving pregnant individuals who use substances can be challenged by mistrust due to SUD-related stigma. To address this, the HBCD Study integrates certified peer support specialists and/or other support professionals (case managers, doulas, social workers, etc.) i.e., Study Navigators, to provide participant-centered support (substance-involved or otherwise) throughout the study. A “contact” includes all scheduled or unscheduled interactions relevant to the study or when providing additional support services to the participant. Contacts can be face-to-face interactions, phone calls, text chats, or other forms of communication between a participant and a research team member providing navigation services. The breadth of the provision of Study Navigator support is determined based on the needs and capacity of each HBCD site. For details on the conceptual framework, core skills, training, and team integration of support professionals, see Hilliard et al. 2025.

The HBCD Study Navigator Workgroup created this form in 2022 by integrating contact form information from other behavioral health practices. The “Support Services Offered” section of the form is original and was created specifically for the HBCD study. This data is purely descriptive and thus not scored. It documents: visit details (date, time, location, scheduling, etc.), support topics discussed, and actions taken during each contact. Options for actions taken include the following:

• Referrals: The navigator initiates a connection between individuals or entities (e.g., a community service, clinical service, or research team member) to help the participant access needed support or services.
• Resources: The navigator shares information (e.g., flyers, brochures, websites) that the participant can use to obtain additional information, support, or services.
• Discussion: The participant asks the navigator to listen and/or discuss sensitive matters related to the research study or their personal life. When appropriate, navigators remind participants that they are mandatory reporters. A discussion may lead to a referral or the provision of resources.
• Other: Any other support provided by the navigator that does not fit the categories of referral, resource, or discussion.

General Variables🔗

Variable	Description	Possible Values (if categorical)
FORM_SITE	Study site of contact	—
CV_CUSTOM_ID_COPY	Participant ID number	—
FORM_SOURCE	Respondent	CH (Child); BP (Birth Parent)
WHO_SCHEDULED_CONTACT	Who scheduled visit	participant; navigator; research_coordinator_ra; other
SINGLE_OR_MULTIPLE_CONTACTS	Single or multiple contacts	one_contact; multiple_contacts
CONTACT_SITE	Site of contact	clinic; community; home; hospital; other; phone; research_facility; zoom
SUCCESSFUL_CONTACT	Navigator completed a contact with the participant	yes; no
WHY_UNABLE_TO_CONTACT	Reason if unable to contact	declined_to_continue; did_not_present; did_not_respond_to_contact; other; participant_left_b4_contact; prefer_to_complete_later; unable_to_complete_due_to_circumstances
IS_FOLLOW_UP_NEEDED	Follow-up needed	yes; no
IS_CONTACT_SCHEDULED	Follow-up contact scheduled	yes; no
AGE_IN_WEEKS_EDD_AT_CONTACT	Age at contact	—
AGE_IN_WEEKS_EDD_NEXT_CONTACT	Age at next contact	—
AGE_IN_WEEKS_EDD_FINAL_NAV_CONTACT	Age at final contact	—
AGE_IN_EDD_WEEKS_DATE_OF_COMPLETION	Age on completion date	—

Barriers Variables🔗

NOTE: All RESPONSE OPTION values are appended with the relevant actions taken to barriers faced, including referrals, resources, discussion, and/or other (example: biosensors/referrals).

Variable/Barrier Type	Response Options
BARRIERS_TO_STUDY_ASSESSMENT_CHECKBOXES Relevant study domains	biosensors; biospecimen_collection; eeg; mri; observational_assessments; surveys; other
BARRIERS_TO_STUDY_ASSESSMENT_CHECKBOXES_PART_2 General	childcare; concerns_about_confidentiality; family_instability; lack_of_time; transportation; other
PREGNANCY_AND_LABOR_CHECKBOXES Pregnancy & labor	newborn_and_infant_care; labor_birth; maternal_perinatal_health; postpartum_care; other
CHILD_HEALTH_CHECKBOXES Child health	mental_health; physical_health; safety; other
PARENTS_GUARDIANS_CHECKBOXES Parent or guardians	mental_health; parenting; physical_health; safety; other
BROADER_FAMILY_HEALTH_CHECKBOXES Family health	caregiving; mental_health; physical_health; safety; other
SOCIOECONOMIC_RESOURCES_CHECKBOXES Socioeconomic	childcare; financial; food_nutrition; housing; transportation; other
SUBSTANCE_USE_CHECKBOXES Substance use	behavioral; medical; recovery; other
OTHER_CHECKBOXES Other	family_crisis; court_or_legal; other

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