Parenting Young Children in Pediatrics

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273228
• Other study ID #: STUDY00000788
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: University of Oregon
• Contact: Katherine Hails, PhD
• Phone: 610-457-8627
• Email: khails[@]uoregon.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 respond "yes" to any of the five following screening questions addressing lifetime family substance misuse: 1) Have you ever drunk alcohol or used drugs more than you meant to? 2) Have you ever participated in treatment for substance use? 3) Have you ever felt you wanted or needed to cut down on your drinking or drug use? 4) Have you ever lived with anyone who had a problem with drinking or using drugs, including prescription drugs? 5) Has a family member's drinking or drug use ever impacted your 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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Prevention Science Institute, University of Oregon	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Oregon	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	change from baseline in parental substance use	Parental substance use will be measured with the Opioid and Other Substance Use Involvement measure from the HEAL Prevention Cooperative Common Constructs. This measure assesses participants' use of alcohol, cannabis, prescription opioids, illegally manufactured opioids, and stimulants. Items ask about initiation of substance use, frequency of recent use, and if use reaches threshold of Substance Use Disorder. Items can currently be used as individual outcome measures. Analysts are currently determining how best to create an overall subscale score for each of these substances.	baseline, 3 months
Primary	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
Primary	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
Primary	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
Primary	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