Parenting Young Children in Pediatrics

NCT06273228 | Completed

• 2 other identifiers: STUDY00000788P50DA048756
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parenting; Parent-Child Relations; Substance Use Disorders; Stress; Depression; Anxiety; Parenting Self-efficacy; Pediatrics

Keywords

Parenting Intervention; Family Check-Up

Outcome Measures

Primary Outcomes (9)

• change from baseline in parenting skills

  Parenting skills will be measured with the Parenting Young Children Questionnaire (PARYC). Scores range from 1-7; a higher score indicates more positive parenting.

  Time Frame: baseline, 3 months

• change from baseline in parenting efficacy

  Parenting self-efficacy will be measured with the Behavioral Self-Efficacy subscale (PAREFF) of the Parenting Tasks Checklist. Scores range from 1-5; a higher score indicates greater parenting efficacy.

  baseline, 3 months

• change from baseline in parent executive functioning

  Parent executive functioning will be measured with the Behavior Rating Index of Executive Function (BRIEF). Scores range from 1-3; a higher score indicates greater difficulty with executive function.

  baseline, 3 months

• change from baseline in child social-emotional behavior

  Child social-emotional behavior will be measured with the Brief Infant-Toddler Social-Emotional Assessment (BITSEA). Scores range from 1-3; a higher score indicates more positive child social-emotional behavior.

  baseline, 3 months

• change from baseline in family conflict

  Family conflict will be measured with the Family Conflict Scale. Scores range from 1-7; a higher score indicates a higher frequency of family conflict.

  baseline, 3 months

• change from baseline in parental depression

  Parental depression will be measured with the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0-3; a higher score indicates greater depression.

  baseline, 3 months

• change from baseline in parental anxiety

  Parental anxiety will be measured with the General Anxiety Disorder-7 (GAD-7). Scores range from 0-3; a higher score indicates greater anxiety.

  baseline, 3 months

• change from baseline in parental stress

  Parental stress will be measured with the Perceived Stress Scale. Scores range from 0-56; a higher score indicates high perceived stress.

  baseline, 3 months

• change from baseline in parental impact of negative life events

  The impact of negative life events will be measured with the life events subscale of the Parent Self-Check (PARSC). Scores range from 1-5; a higher score indicates greater impact of negative life events.

  baseline, 3 months

Study Arms (1)

Parent participants

EXPERIMENTAL

Parents receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.

Behavioral: Family Check-Up Online

Interventions

Family Check-Up Online BEHAVIORAL

This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers.

Parent participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a parent of a child between the ages of 10 months and 5 years that lives in the parent's home at least 50% of the time;
• Must be over the age of 18;
• Must speak English fluently;
• Must have a smart phone with text messaging capability and access to email;
• Must endorse "yes" on at least one of the five following screening questions addressing lifetime family substance misuse: 1) participant has ever drunk alcohol or used drugs more than they meant to, 2) participant has ever participated in treatment for substance use, 3) participant has ever felt they wanted or needed to cut down on their drinking or drug use, 4) participant ever ever lived with someone who had a problem with drinking or using drugs, including prescription drugs, and 5) a family member's drinking or drug use ever impacted the participant's child. Note: Items 1, 3, and 5 were adapted from the Family Questions section of the Survey of Well-Being of Young Children (SWYC) screening form, which has been recommended by the American Academy of Pediatrics for use as a screening tool in pediatric primary care settings. Adaptations made reflect lifetime family substance misuse instead of family substance misuse in the past year. Item 2 was added to include parents in substance use treatment, and item 4 was adapted from the Adverse Childhood Experience Questionnaire for Adults to further reflect family substance use.

You may not qualify if:

• \- None

Sponsors & Collaborators

• University of Oregon: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Prevention Science Institute, University of Oregon

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Katherine Hails, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: September 27, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)