Family Check-Up for Enhancing Parenting Skills

Overseen By Project Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oregon

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

356 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on enhancing parenting skills through an online program, so it's best to consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Family Check-Up for enhancing parenting skills?

Research shows that the Family Check-Up treatment helps reduce child behavior problems and improve parenting skills by providing tailored support and strategies. Parents reported satisfaction with the program, noting benefits like better family relationships and learning new parenting techniques. ^{1 2 3 4 5}

Is the Family Check-Up program safe for participants?

The Family Check-Up program is generally considered safe for participants, as it focuses on improving parenting skills and child behavioral health without any reported safety concerns in the studies reviewed. ^{1 5 6 7 8}

How is the Family Check-Up treatment different from other parenting interventions?

The Family Check-Up is unique because it is a trauma-informed, strengths-based intervention that focuses on promoting positive parenting skills and reducing child behavior problems by evaluating various ecological and contextual factors. It is tailored to individual family needs and includes components like motivational interviewing, videotaping, and home practice to engage families and support long-term change. ^{1 2 5 9 10}

Research Team

Elizabeth Stormshak, PhD

Principal Investigator

University of Oregon

Eligibility Criteria

This trial is for parents or legal guardians in rural Oregon with children aged 18 months to 5 years, who are willing to use a telehealth program aimed at improving parenting. Participants must have a smartphone and access to email, acknowledge binge drinking or drug use within the last year, or feel depressed recently.

Inclusion Criteria

I am a parent or guardian of a young child who lives with me most of the time.

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

You have engaged in binge drinking and/or recreational drug use in the past year, have a history of prescription opioid use, or have felt very sad for the past two weeks.

Exclusion Criteria

N/A

must have a smart phone with text messaging capability and access to email

I live in Oregon and am a parent or guardian of a young child who lives with me at least half the time.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Study

A 2-month feasibility study to test the adapted version of the FCU Online and refine intervention procedures and usability

8 weeks

Treatment

Participants receive the FCU Online intervention or services as usual, with telehealth coaching and support

12 months

Telehealth sessions as needed

Follow-up

Participants are monitored for changes in parental stress, child social-emotional behavior, family conflict, and other outcomes

12 months

Data collection at baseline, 3 months, 6 months, and 12 months

Treatment Details

Interventions

• Family Check-Up

Trial Overview The study tests the Family Check-Up Online (FCU Online), designed to enhance parenting skills and prevent opioid misuse among parents. It involves coaching via telehealth and focuses on stress management, self-regulation, and building positive parent-child relationships.

Participant Groups

Group I: FCU Online + Coach Experimental Treatment 1 Intervention

Parents in this arm will 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.

Group II: Waitlist Control Active Control 1 Intervention

Parents in this arm will initially serve as the control group but will receive access to the FCU Online website and telehealth coaching after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).

Who Is Running the Clinical Trial?

University of Oregon

Lead Sponsor

Trials

91

Recruited

46,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

The Family Check-Up (FCU) intervention significantly reduces conduct problems in children, especially for those whose parents reported high levels of conduct problems at the start of the study, involving 731 mother-child dyads followed from ages 2 to 9.5.

The FCU not only decreased conduct problems but also improved positive interactions between parents and children, demonstrating its effectiveness in enhancing family dynamics regardless of the initial level of conduct problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Family Check-Up on reducing growth in conduct problems from toddlerhood through school age: An analysis of moderated mediation. Shelleby, EC., Shaw, DS., Dishion, TJ., et al.[2020]

The DELFIN behavioral group training program significantly improved parenting behavior in conflict situations among parents of children with type 1 diabetes after 3 months, with effects remaining stable after 12 months.

Parents in the intervention group experienced reduced depression and anxiety scores, indicating potential psychological benefits, although the differences compared to the control group were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing stress and supporting positive relations in families of young children with type 1 diabetes: a randomized controlled study for evaluating the effects of the DELFIN parenting program. Sassmann, H., de Hair, M., Danne, T., et al.[2021]

The Family Check-Up 4 Health (FCU4Health) program, tested on 240 pediatric patients with elevated BMI, showed significant improvements in parenting skills and child behavioral health within 6 months compared to usual care.

Improvements in parenting were linked to better child self-regulation, which subsequently led to reductions in conduct and emotional problems, indicating a positive chain reaction from the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Family Check-Up 4 Health on Parenting and Child Behavioral Health: A Randomized Clinical Trial in Primary Care. Berkel, C., Fu, E., Carroll, AJ., et al.[2021]

The Family Check-Up (FCU) intervention, involving 593 ethnically diverse families, effectively reduced the escalation of adolescent problem behaviors, including family conflict, antisocial behavior, and alcohol use, during the transition to high school.

Youth whose parents participated in the FCU showed significantly lower rates of these problem behaviors compared to a matched control group, highlighting the importance of engaging families in interventions to support adolescent development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging parents in the family check-up in middle school: longitudinal effects on family conflict and problem behavior through the high school transition. Van Ryzin, MJ., Stormshak, EA., Dishion, TJ.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Swedish parents' satisfaction and experience of facilitators and barriers with Family Check-up: A mixed methods study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of the Family Check-Up on reducing growth in conduct problems from toddlerhood through school age: An analysis of moderated mediation. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Reducing stress and supporting positive relations in families of young children with type 1 diabetes: a randomized controlled study for evaluating the effects of the DELFIN parenting program. [2021]

4. England pubmed.ncbi.nlm.nih.gov

An evaluation of a service to keep children safe in families with mental health and/or substance abuse issues. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Family Check-Up: Ecological Family-Based Assessments in the Context of Potential Child Abuse or Chaotic Home Environments. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of the Family Check-Up 4 Health on Parenting and Child Behavioral Health: A Randomized Clinical Trial in Primary Care. [2021]

7. England pubmed.ncbi.nlm.nih.gov

'Baby Check' in the inner city--use and value to parents. [2019]

8. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of the strategy of parental support at primary health care as a reinforcement of the online course 'Gaining health and wellbeing from birth to three'.] [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Engaging parents in the family check-up in middle school: longitudinal effects on family conflict and problem behavior through the high school transition. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Predictors of Participation in the Family Check-Up Program: a Randomized Trial of Yearly Services from Age 2 to 10 Years. [2020]