Clinical trial NCT05180487: Parenting Young Children Study
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parenting
Parent-Child Relations
Opioid Misuse
Opioid Use Disorder
Executive Function
Stress
Depression
Parenting Self-efficacy
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-01-06
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Families will be assigned to treatment vs. wait-list control. The investigators will assess families at baseline and at 3-, 6-, and 12-month follow-ups. Families in the treatment condition will receive the intervention between baseline and the 3-month follow-up. The control group will receive the intervention following the 12-month follow-up.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: change from baseline in parenting skills
timeFrame: baseline, 3 months, 6 months, 12 months
measure: change from baseline in parenting efficacy
timeFrame: baseline, 3 months, 6 months, 12 months
measure: change from baseline in parent executive functioning
timeFrame: baseline, 3 months, 6 months, 12 months
measure: change from baseline in child social-emotional behavior
timeFrame: baseline, 3 months, 6 months, 12 months
measure: change from baseline in family conflict
timeFrame: baseline, 3 months, 6 months, 12 months
measure: change from baseline in parental substance use
timeFrame: baseline, 3 months, 6 months, 12 months
measure: change from baseline in parental depression
timeFrame: baseline, 3 months, 6 months, 12 months
measure: change from baseline in parental anxiety
timeFrame: baseline, 3 months, 6 months, 12 months
measure: change from baseline in parental stress
timeFrame: baseline, 3 months, 6 months, 12 months
measure: change from baseline in parental impact of negative life events
timeFrame: baseline, 3 months, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: University of Oregon Prevention Science Institute
state: Oregon
Study officials:
affiliation: University of Oregon
name: Elizabeth Stormshak, PhD
role: PRINCIPAL_INVESTIGATOR
References: