ParentingNCT05180487
Parenting Young Children Study
A study testing Family Check-Up in people with Parenting and Parent-Child Relations, run by University of Oregon at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Parent-Child Relations, Opioid Misuse
- What is being tested?
- Family Check-Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oregon Prevention Science Institute
Portland, Oregon, 97209
About this 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
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.
Read more
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:
- 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.
- 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.
- 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.
- Conditions
- Parenting, Parent-Child Relations, Opioid Misuse, Opioid Use Disorder, Stress, Depression
- Being tested
- Family Check-Up
- Medical subject headings
- Opioid-Related Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Check-UpBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FCU Online + Coach | Experimental | 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. Receives: Behavioral: Family Check-Up |
| Waitlist Control | No intervention | Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Parenting Skills: Supporting Positive Behavior
Parents' skill in supporting positive behavior was measured with the "supporting positive behavior" subscale of the Parenting Young Children Questionnaire (PARYC). Scores could range from 7-49; a higher score indicates greater skill in supporting positive behavior.
Measured: baseline, 3 months, 6 months, 12 months
Change From Baseline in Parenting Skills: Setting Limits
Parents' skill in setting limits was measured with the "setting limits" subscale of the Parenting Young Children Questionnaire (PARYC). Scores could range from 7-49; a higher score indicates greater skill in setting limits.
Measured: baseline, 3 months, 6 months, 12 months
Change From Baseline in Parenting Skills: Proactive Parenting
Parents' skill in proactive parenting was measured with the "proactive parenting" subscale of the Parenting Young Children Questionnaire (PARYC). Scores could range from 7-49; a higher score indicates greater skill in proactive parenting.
Measured: baseline, 3 months, 6 months, 12 months
Change From Baseline in Parenting Confidence
Parents' confidence in their parenting skills was measured with the Behavioral Self-Efficacy subscale (PAREFF) of the Parenting Tasks Checklist. Scores could range from 1-5; a higher score indicates greater parent confidence.
Measured: baseline, 3 months, 6 months, 12 months
Change From Baseline in Parent Alcohol Use
Parent substance use was 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. A series of questions were asked about each substance of interest, starting with a question assessing if the parent had ever used the substance. Parents who responded "yes" received additional questions about that substance. Parents who responded "no" did not receive additional questions about that substance.
Parents who indicated prior alcohol use were asked: "During the past 30 days, how many days did you drink alcohol?" Responses could range from 0-30 days. Higher scores indicate more frequent use of alcohol.
Measured: baseline, 3 months, 6 months, 12 months
Change From Baseline in Parent Marijuana Use
Parent substance use was 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. A series of questions were asked about each substance of interest, starting with a question assessing if the parent had ever used the substance. Parents who responded "yes" received additional questions about that substance; parents who responded "no" did not. The following header was included at the beginning of the section about marijuana use: "The next questions are about marijuana. Marijuana is also called pot, weed, or cannabis. These questions DO NOT include CBD only."
Parents with prior marijuana use were asked: "During the past 30 days, how many days did you use marijuana?" Responses could range from 0-30 days. Higher scores indicate more frequent use of marijuana.
Measured: baseline, 3 months, 6 months, 12 months
Change From Baseline in Parent Prescription Opioid Use
Parent substance use was measured with the Opioid and Other Substance Use Involvement measure from the HEAL Prevention Cooperative. For each substance, parents were asked if they had ever used it. Parents who responded "yes" received additional questions; parents who responded "no" did not. A header in the section about use of prescription opioids read: "This next item asks about using prescription opioids for pain relief or treatment...in any way a doctor or medical provider did not tell you to use them. This includes:
- Using without a prescription of your own (for example, someone else's medicine)
- Using more or for longer than you were told to take it
- Using for reasons other than pain (such as to get high, to sleep, or for anxiety)"
Parents with prior prescription opioid misuse were asked: "During the past 30 days, how many days did you use a prescription opioid?" Responses could range from 0-30 days. Higher scores indicate more frequent use of prescription opioids.
Measured: baseline, 3 months, 6 months, 12 months
Change From Baseline in Parent Use of Illegally Manufactured Opioids
Parent substance use was 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. A series of questions were asked about each substance of interest, starting with a question assessing if the parent had ever used the substance. Parents who responded "yes" received additional questions about that substance; parents who responded "no" did not. The following header was included at the beginning of the section about illegally manufactured opioids: "The next questions ask about manufactured opioids including heroin (also called black tar, poppy, or smack) and Fentanyl."
Parents with prior use of illegally manufactured opioids were asked: "During the past 30 days, how many days did you use heroin?" Responses could range from 0-30 days. Higher scores indicate more frequent use of heroin.
Measured: baseline, 3 months, 6 months, 12 months
Change From Baseline in Parent Stimulant Use
Parent substance use was measured with the Opioid and Other Substance Use Involvement measure from the HEAL Prevention Cooperative Common Constructs. A series of questions were asked about each substance of interest, starting with a question assessing if the parent had ever used the substance. Parents who responded "yes" received additional questions about that substance; parents who responded "no" did not. The following header was included at the beginning of the section about use of stimulants: "The next questions ask about stimulants. Some examples of stimulants include: Adderall, Concerta, Cylert, Provigil, Ritalin or Dexedrine, speed, amphetamine, methamphetamine, uppers, bennies, pep pills, crystal, crank."
Parents with prior stimulant use were asked: "During the past 30 days, how many days did you use stimulants?" Responses could range from 0-30 days. Higher scores indicate more frequent use of stimulants.
Measured: baseline, 3 months, 6 months, 12 months
Change From Baseline in Parental Depression
Parental depression was measured with the Patient Health Questionnaire-9 (PHQ-9). Scores could range from 0-27; a higher score indicates greater depression.
Measured: baseline, 3 months, 6 months, 12 months
Change From Baseline in Parental Anxiety
Parental anxiety was measured with the General Anxiety Disorder-7 (GAD-7). Scores could range from 0-21; a higher score indicates greater anxiety.
Measured: baseline, 3 months, 6 months, 12 months
Change From Baseline in Parental Stress
Parental stress was measured with the Perceived Stress Scale. Scores could range from 0-56; a higher score indicates high perceived stress.
Measured: baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start6 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Stormshak, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180487
- Sponsor's protocol ID
- 10212019.029
- Other IDs
- P50DA048756, P50DA048756-01S1
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2021
- Last updated
- 27 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hails KA, Stormshak EA, Seeley JR, Mauricio AM. Supporting parenting during early childhood with the family check-up online: A randomized clinical trial. J Fam Psychol. 2026 Aug 13:10.1037/fam0001531. doi: 10.1037/fam0001531. Online ahead of print.
PubMed 42593979
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05180487
- Acronym / sponsor ID
- 10212019.029
- Conditions
- Parenting, Parent-Child Relations, Opioid Misuse, Opioid Use Disorder, Stress, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Posted 27 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| FCU Online + Coach | Experimental | Behavioral: Family Check-UpParents 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. |
| Waitlist Control | No intervention | –Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Check-UpThis 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. | Behavioural | FCU Online + Coach |
Primary outcome
Change From Baseline in Parenting Skills: Supporting Positive Behavior
Time frame: baseline, 3 months, 6 months, 12 months
Parents' skill in supporting positive behavior was measured with the "supporting positive behavior" subscale of the Parenting Young Children Questionnaire (PARYC). Scores could range from 7-49; a higher score indicates greater skill in supporting positive behavior.
Change From Baseline in Parenting Skills: Setting Limits
Time frame: baseline, 3 months, 6 months, 12 months
Parents' skill in setting limits was measured with the "setting limits" subscale of the Parenting Young Children Questionnaire (PARYC). Scores could range from 7-49; a higher score indicates greater skill in setting limits.
Change From Baseline in Parenting Skills: Proactive Parenting
Time frame: baseline, 3 months, 6 months, 12 months
Parents' skill in proactive parenting was measured with the "proactive parenting" subscale of the Parenting Young Children Questionnaire (PARYC). Scores could range from 7-49; a higher score indicates greater skill in proactive parenting.
Change From Baseline in Parenting Confidence
Time frame: baseline, 3 months, 6 months, 12 months
Parents' confidence in their parenting skills was measured with the Behavioral Self-Efficacy subscale (PAREFF) of the Parenting Tasks Checklist. Scores could range from 1-5; a higher score indicates greater parent confidence.
Change From Baseline in Parent Alcohol Use
Time frame: baseline, 3 months, 6 months, 12 months
Parent substance use was 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. A series of questions were asked about each substance of interest, starting with a question assessing if the parent had ever used the substance. Parents who responded "yes" received additional questions about that substance. Parents who responded "no" did not receive additional questions about that substance. Parents who indicated prior alcohol use were asked: "During the past 30 days, how many days did you drink alcohol?" Responses could range from 0-30 days. Higher scores indicate more frequent use of alcohol.
Change From Baseline in Parent Marijuana Use
Time frame: baseline, 3 months, 6 months, 12 months
Parent substance use was 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. A series of questions were asked about each substance of interest, starting with a question assessing if the parent had ever used the substance. Parents who responded "yes" received additional questions about that substance; parents who responded "no" did not. The following header was included at the beginning of the section about marijuana use: "The next questions are about marijuana. Marijuana is also called pot, weed, or cannabis. These questions DO NOT include CBD only." Parents with prior marijuana use were asked: "During the past 30 days, how many days did you use marijuana?" Responses could range from 0-30 days. Higher scores indicate more frequent use of marijuana.
Change From Baseline in Parent Prescription Opioid Use
Time frame: baseline, 3 months, 6 months, 12 months
Parent substance use was measured with the Opioid and Other Substance Use Involvement measure from the HEAL Prevention Cooperative. For each substance, parents were asked if they had ever used it. Parents who responded "yes" received additional questions; parents who responded "no" did not. A header in the section about use of prescription opioids read: "This next item asks about using prescription opioids for pain relief or treatment...in any way a doctor or medical provider did not tell you to use them. This includes: * Using without a prescription of your own (for example, someone else's medicine) * Using more or for longer than you were told to take it * Using for reasons other than pain (such as to get high, to sleep, or for anxiety)" Parents with prior prescription opioid misuse were asked: "During the past 30 days, how many days did you use a prescription opioid?" Responses could range from 0-30 days. Higher scores indicate more frequent use of prescription opioids.
Change From Baseline in Parent Use of Illegally Manufactured Opioids
Time frame: baseline, 3 months, 6 months, 12 months
Parent substance use was 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. A series of questions were asked about each substance of interest, starting with a question assessing if the parent had ever used the substance. Parents who responded "yes" received additional questions about that substance; parents who responded "no" did not. The following header was included at the beginning of the section about illegally manufactured opioids: "The next questions ask about manufactured opioids including heroin (also called black tar, poppy, or smack) and Fentanyl." Parents with prior use of illegally manufactured opioids were asked: "During the past 30 days, how many days did you use heroin?" Responses could range from 0-30 days. Higher scores indicate more frequent use of heroin.
Change From Baseline in Parent Stimulant Use
Time frame: baseline, 3 months, 6 months, 12 months
Parent substance use was measured with the Opioid and Other Substance Use Involvement measure from the HEAL Prevention Cooperative Common Constructs. A series of questions were asked about each substance of interest, starting with a question assessing if the parent had ever used the substance. Parents who responded "yes" received additional questions about that substance; parents who responded "no" did not. The following header was included at the beginning of the section about use of stimulants: "The next questions ask about stimulants. Some examples of stimulants include: Adderall, Concerta, Cylert, Provigil, Ritalin or Dexedrine, speed, amphetamine, methamphetamine, uppers, bennies, pep pills, crystal, crank." Parents with prior stimulant use were asked: "During the past 30 days, how many days did you use stimulants?" Responses could range from 0-30 days. Higher scores indicate more frequent use of stimulants.
Change From Baseline in Parental Depression
Time frame: baseline, 3 months, 6 months, 12 months
Parental depression was measured with the Patient Health Questionnaire-9 (PHQ-9). Scores could range from 0-27; a higher score indicates greater depression.
Change From Baseline in Parental Anxiety
Time frame: baseline, 3 months, 6 months, 12 months
Parental anxiety was measured with the General Anxiety Disorder-7 (GAD-7). Scores could range from 0-21; a higher score indicates greater anxiety.
Change From Baseline in Parental Stress
Time frame: baseline, 3 months, 6 months, 12 months
Parental stress was measured with the Perceived Stress Scale. Scores could range from 0-56; a higher score indicates high perceived stress.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42593979Hails KA, Stormshak EA, Seeley JR, Mauricio AM. Supporting parenting during early childhood with the family check-up online: A randomized clinical trial. J Fam Psychol. 2026 Aug 13:10.1037/fam0001531. doi: 10.1037/fam0001531. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Stormshak, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Check-Up in people with Parenting and Parent-Child Relations, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Parenting Skills: Supporting Positive Behavior (time frame: baseline, 3 months, 6 months, 12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05180487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.