Parenting Young Children Study

Depression Clinical Trial

Official title:

Rural Families Affected by Opioid Use: An Online Parenting Intervention; and Supplement to Prevention Research Center: Parenting Among Women Who Are Opioid Users, Project 2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05180487
• Other study ID #: 10212019.029
• Secondary ID: P50DA048756P50DA
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 6, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Opioid use is rising at unprecedented levels and has reached epidemic proportions in some areas of the country, particularly rural areas. Although research on the detrimental effects of opioid use on parenting and children is relatively new, it is clear that parents with opioid use struggle with a variety of parenting skills, especially contingent responsivity and warmth. As such, to have long-term sustained effects on preventing Opioid Use Disorder (OUD) in parents and to help prevent substance use and related problem behaviors in the next generation, it is critical to prevent opioid use, opioid misuse, and OUD in new parents, in tandem with providing support for parenting skills.

The Family Check-Up Online (FCU Online) focuses on supporting parents by increasing parenting self-efficacy, stress management skills, self-regulation skills, and sleep routines, which are hypothesized to lead to the prevention of opioid misuse and OUD as well as improve mental health and increase responsive parenting. The FCU Online is based on the Family Check-Up, which has been tested in more than 25 years of research, across multiple settings, and is an evidence-based program for reducing high-risk behavior, enhancing parenting skills, and preventing substance use through emerging adulthood. It is named in NIDA's "Principles of Substance Use Prevention for Early Childhood" as one of only three effective selective prevention programs for substance abuse among families with young children. The FCU has also been endorsed as an evidence-based practice by the Maternal Infant and Early Childhood Home Visiting Program (MIECHV), and has been listed as a promising program by the Blueprints for Healthy Youth Development since 2013.

The current project aims to address barriers of access to prevention services by delivering the FCU in a telehealth model using the FCU Online. In this research study the investigators will:

1. Work with community stakeholders in rural Oregon to expand the FCU Online to target early childhood (ages 18 months-5 years) and mothers with opioid misuse and addiction. Guided by focus group feedback, the FCU Online will be adapted to target parenting skills relevant to mothers with opioid misuse, including positive parenting, parent-child relationship building, executive functioning to help manage stress and depression, and negative parenting. A 2-month feasibility study (n=10) will test the adapted version of the FCU Online and help investigators refine intervention procedures and usability, recruitment steps, and assessment delivery.

2. Examine the efficacy of the FCU Online for rural families with opioid or other substance misuse. 400 parents with preschool children ages 18 months to 5 years and who have been identified with substance misuse, opioid misuse, or addiction will be randomly assigned to receive the FCU Online or services as usual and followed for one year. A telehealth model will be used for intervention delivery that includes targeted coaching and support. The investigators predicted that parents assigned to the FCU Online intervention will (a) show improvements in parenting skills linked to improvements in child behavior and long-term risk for subsequent substance abuse, and (b) show improvements in self-regulation and executive functioning (inhibitory control, attention shifting), which will mediate intervention effects. The investigators will also examine moderators, including neonatal abstinence syndrome/neonatal opioid withdrawal syndrome, and model intervention effects over time.

3. Examine factors related to successful uptake and implementation. To facilitate dissemination on a national scale, investigators will assess the feasibility of the FCU as an Internet-delivered intervention in rural communities with high levels of opioid use, including the extent to which participants engaged in the intervention, completed the program, and were satisfied with the program. Investigators will also assess feasibility, usage, fidelity, and uptake through engagement data collected via the online web portal. The investigators will develop materials and briefings for community agencies that will increase knowledge dissemination and, ultimately, reach a greater number of families throughout the United States who need information and services for parenting support in the context of opioid misuse.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 356
• Est. completion date: May 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be a parent or legal guardian of a child between the ages of 18 months and 5 years old that lives in the parent's home at least 50% of time;

• Must have a smart phone with text messaging capability and access to email;

• Must be willing to complete phone interviews and use a telehealth program that focuses on strengthening parenting;

• Must respond 'yes' to binge drinking and/or recreational drug use in the last year, lifetime use of prescription opioids, or depressed mood in the last two weeks.

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Depression
• Executive Function
• Opioid Misuse
• Opioid Use Disorder
• Opioid-Related Disorders
• Parent-Child Relations
• Parenting
• Parenting Self-efficacy
• Stress

Intervention

Behavioral:
• Family Check-Up
This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.

Locations

Country	Name	City	State
United States	University of Oregon Prevention Science Institute	Portland	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.	baseline, 3 months, 6 months, 12 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, 6 months, 12 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, 6 months, 12 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, 6 months, 12 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, 6 months, 12 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, 6 months, 12 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, 6 months, 12 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, 6 months, 12 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, 6 months, 12 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, 6 months, 12 months