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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA048756 | U.S. NIH Grant/Contract | View source | |
| P50DA048756-01S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family Check-Up | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Stormshak, PhD | University of Oregon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oregon Prevention Science Institute | Portland | Oregon | 97209 | United States |
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947 parents inquired about study participation. Some were excluded due to being unresponsive to outreach (n=289), inquiring after recruitment was closed (n=12), not meeting inclusion criteria (n=244), or declining to participate (n=20). 382 parents qualified to participate, and 356 completed the consent process and baseline data collection. Parents who returned baseline surveys (n=356) were randomly assigned to one of two conditions.
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| ID | Title | Description |
|---|---|---|
| FG000 | FCU Online + Coach | 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. 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. |
| FG001 | Waitlist Control | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 12-month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | FCU Online + Coach | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | N=355 for this question, rather than N=356, because data is missing for one participant in the FCU Online + Coach condition. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, 12 months |
|
Participants were monitored for adverse events over the study period (until their 12-month post-test was completed).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FCU Online + Coach | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Beth Stormshak | University of Oregon | 541-346-2152 | bstorm@uoregon.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 18, 2025 | Dec 30, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2019 | Dec 30, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 13, 2024 | Oct 14, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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| 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. | 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:
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. | 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. | 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. | 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. | 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. | 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. | baseline, 3 months, 6 months, 12 months |
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| BG001 | Waitlist Control | 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). |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | N=354 for this question, rather than N=356, because two participants in the waitlist control condition chose not to respond to this demographic question. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Waitlist Control | 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). |
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| Primary | 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. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, 12 months |
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|
|
| Primary | 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. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, 12 months |
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|
| Primary | 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. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, 12 months |
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| Primary | 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. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). | Posted | Mean | Standard Deviation | days | baseline, 3 months, 6 months, 12 months |
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| Primary | 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. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). | Posted | Mean | Standard Deviation | days | baseline, 3 months, 6 months, 12 months |
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| Primary | 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:
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. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). | Posted | Mean | Standard Deviation | days | baseline, 3 months, 6 months, 12 months |
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| Primary | 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. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). | Posted | Mean | Standard Deviation | days | baseline, 3 months, 6 months, 12 months |
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| Primary | 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. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). | Posted | Mean | Standard Deviation | days | baseline, 3 months, 6 months, 12 months |
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| Primary | 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. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). Because no families were ever lost to follow-up or withdrew from the study, all families who participated at baseline were invited to participate at each follow-up wave. Thus, there are a few families who participated at 12-month follow-up who did not participate at an earlier follow-up wave. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, 12 months |
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| Primary | 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. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). Because no families were ever lost to follow-up or withdrew from the study, all families who participated at baseline were invited to participate at each follow-up wave. Thus, there are a few families who participated at 12-month follow-up who did not participate at an earlier follow-up wave. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, 12 months |
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| Primary | 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. | Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). Because no families were ever lost to follow-up or withdrew from the study, all families who participated at baseline were invited to participate at each follow-up wave. Thus, there are a few families who participated at 12-month follow-up who did not participate at an earlier follow-up wave. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, 12 months |
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| 0 |
| 180 |
| 0 |
| 180 |
| 0 |
| 180 |
| EG001 | Waitlist Control | 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). | 0 | 176 | 0 | 176 | 0 | 176 |
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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