protocolSection identificationModule nctId: NCT06273228, orgStudyIdInfo id: STUDY00000788, briefTitle: Parenting Young Children in Pediatrics, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of Oregon, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: Research suggests that one in eight children in the U.S. currently lives with a parent with a substance use disorder. Parents who misuse substances are at increased risk of using harsh and other negative parenting practices with their young children, who are more likely to face challenges with emotional and behavioral regulation and subsequently misuse substances themselves. There is thus an urgent need for evidence-based interventions to promote positive parenting skills in parents who misuse substances. Interventions must be convenient, non-stigmatizing, and accessible to parents with problematic substance use, who frequently face barriers to engaging with healthcare systems. Pediatric primary care is an ideal setting to offer a brief intervention for maladaptive parenting behaviors associated with parental substance use, as the vast majority of children under 5 access pediatric primary care at least annually and parents generally report high levels of trust in their child's pediatrician.The Family Check-Up (FCU) Online app, which was created specifically to promote positive parenting skills in parents with past or current substance misuse, is ideal for delivery to parents with pre-school age children in a pediatric primary care setting as it is brief, convenient, and delivered in a self-directed format that parents favor. The main objective of this pilot study is to test the feasibility and acceptability of the FCU-Online, a brief, app-based parenting intervention, for parents reporting lifetime problematic substance use in a pediatric primary care setting.In this study, investigators will partner with pediatric primary care providers to recruit parent participants, then evaluate feasibility and acceptability by systematically assessing parents' engagement with the FCU Online app. Engagement data from the app includes time spent in app overall and in each module, activities completed, and which modules were accessed. Investigators will also administer a consumer satisfaction survey, which will ask parents to report on their perceptions of the app (e.g., helpfulness, useability, and effects on parenting). To assess engagement in telehealth coaching sessions, investigators will use the following variables: number of telehealth sessions completed, length of session, content of sessions, and coaches' ratings of participant engagement in the session and barriers to using the app. Coaches will also rate participant engagement on a 3-point scale from "low" to "high." Lastly, investigators will conduct qualitative interviews with a sub-sample of participants to solicit additional feedback on the acceptability of the FCU Online, focusing particularly on the perception of acceptability within an integrated primary care context and stigma associated with endorsing substance use in this setting.A second aim of this study is to assess pediatric healthcare providers' perceptions and attitudes regarding the fit of the FCU Online with their practice settings as well as potential barriers to implementation. Through semi-structured focus groups and qualitative interviews with pediatric healthcare providers, investigators will assess provider- and practice-level factors that may facilitate or impede the implementation of the FCU Online in pediatric primary care settings., conditionsModule conditions: Parenting, conditions: Parent-Child Relations, conditions: Substance Use Disorders, conditions: Stress, conditions: Depression, conditions: Anxiety, conditions: Parenting Self-efficacy, conditions: Pediatrics, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Parents will be recruited in pediatric primary care settings and will be assessed at baseline and at a 3-month follow-up. Parents will receive the intervention between baseline and follow-up. Nine parents will be randomly selected for an additional follow-up interview., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Family Check-Up Online, outcomesModule primaryOutcomes measure: change from baseline in parenting skills, primaryOutcomes measure: change from baseline in parenting efficacy, primaryOutcomes measure: change from baseline in parent executive functioning, primaryOutcomes measure: change from baseline in child social-emotional behavior, primaryOutcomes measure: change from baseline in family conflict, primaryOutcomes measure: change from baseline in parental substance use, primaryOutcomes measure: change from baseline in parental depression, primaryOutcomes measure: change from baseline in parental anxiety, primaryOutcomes measure: change from baseline in parental stress, primaryOutcomes measure: change from baseline in parental impact of negative life events, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prevention Science Institute, University of Oregon, status: RECRUITING, city: Eugene, state: Oregon, zip: 97403, country: United States, contacts name: Katherine Hails, PhD, role: CONTACT, phone: 610-457-8627, email: khails@uoregon.edu, contacts name: Elizabeth Stormshak, PhD, role: CONTACT, phone: 541-912-3792, email: bstorm@uoregon.edu, contacts name: Katherine Hails, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.05207, lon: -123.08675, hasResults: False