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OpenTrials
Completed

NCT Number: NCT06273228

Parenting Young Children in Pediatrics

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.

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Key information

Conditions

Parenting Anxiety Anxiety Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Mental Disorders Parent-Child Relations Parenting Self-efficacy Pediatrics Stress Substance Use Disorders Substance-Related Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prevention Science Institute, University of Oregon

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • None

Treatment and study plan

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.

Primary outcomes

  1. change from baseline in parenting skills

    Time frame: Time Frame: baseline, 3 months

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

  2. change from baseline in parenting efficacy

    Time frame: baseline, 3 months

    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.

  3. change from baseline in parent executive functioning

    Time frame: baseline, 3 months

    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.

  4. change from baseline in child social-emotional behavior

    Time frame: baseline, 3 months

    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.

  5. change from baseline in family conflict

    Time frame: baseline, 3 months

    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.

  6. change from baseline in parental depression

    Time frame: baseline, 3 months

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

  7. change from baseline in parental anxiety

    Time frame: baseline, 3 months

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

  8. change from baseline in parental stress

    Time frame: baseline, 3 months

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

  9. change from baseline in parental impact of negative life events

    Time frame: baseline, 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

An Online Parenting Intervention for Families Affected by Substance Misuse in Pediatric Primary Care

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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