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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34AA028856-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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Early alcohol socialization occurs within the family. This multi-level, high-reach, low-intensity intervention to prevent early alcohol use capitalizes on the influence of providers, immunization timing, and pediatric guidelines that advise healthcare providers to give anticipatory guidance about early alcohol use. In conjunction, the intervention capitalizes on the power of technology to reinforce and expand upon pediatrician messages.
The study seeks to understand the feasibility and effectiveness of a pilot intervention designed to prevent alcohol socialization through education of parents of rising 6th grade students.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Families receive text messages for three months. |
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| Waitlist-control arm | No Intervention | Families are randomized into a control group for three months and begin receiving text messages for three months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIPAS Alcohol | Behavioral | Weekly text messages for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Value of Parental Pro-sipping Beliefs Score | Parental Alcohol Socialization Beliefs, Attitudes, and Practices scale (eight items). A four-point scale ranging from "strongly disagree" (lowest value=1) to "strongly agree" (highest value=4) will be used, with higher values on the scale indicating a more pro-sipping belief system. The scores will have a range from 8-32. Higher values are associated with worse outcomes. | Baseline, three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Gilkey, PhD | UNC Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
This study will be following NIAAA's requirements regarding sharing outcome data of sharing de-identified, individual-level data to the NIAAA Data Archive. The data are made public after an embargo period following the end date of the research award.
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after an embargo period following the end date of the research award
In accordance with NIAAA data archive requirements.
Parent-child dyads participated in this study, but only parents/caregivers were considered enrolled. The number started/completed reflects the number of individual parents/caregivers.
Recruitment occurred from May to November 2023. Participants were recruited through school newsletters, social media posts, information dissemination through educational institutions and local pediatric clinics, and word of mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | Families receive text messages for three months. BIPAS Alcohol: Weekly text messages for three months. |
| FG001 | Waitlist-control Arm | Families are randomized into a waitlist control group for three months and begin receiving text messages for three months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Note that demographics were only collected for parent participants (not children).
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | Families receive text messages for three months. BIPAS Alcohol: Weekly text messages for three months. |
| BG001 | Waitlist-control Arm | Families are randomized into a control group for three months and begin receiving text messages for three months. |
| 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, Categorical | Count of Participants |
| 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 in Mean Value of Parental Pro-sipping Beliefs Score | Parental Alcohol Socialization Beliefs, Attitudes, and Practices scale (eight items). A four-point scale ranging from "strongly disagree" (lowest value=1) to "strongly agree" (highest value=4) will be used, with higher values on the scale indicating a more pro-sipping belief system. The scores will have a range from 8-32. Higher values are associated with worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline, three months |
|
Adverse events were not collected.
Adverse events data was not collected as part of this protocol.
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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 | Intervention Arm | Families receive text messages for three months. BIPAS Alcohol: Weekly text messages for three months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nisha Gottfredson O'Shea | RTI International | 9192481826 | nishaoshea@rti.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2024 | Dec 19, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2023 | Dec 5, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000066608 | Underage Drinking |
| D004327 | Drinking Behavior |
| D000428 | Alcohol Drinking |
| D000294 | Adolescent Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | The study was not designed to collect these data; therefore, sex data were not collected. | 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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| Parent drinks alcohol | Count of Participants | Participants |
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| Parent/guardian relationship with child | Parents' self-identified relationship with their child. | Count of Participants | Participants |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Waitlist-control Arm | Families are randomized into a waitlist control group for three months and begin receiving text messages for three months. | 0 | 0 | 0 | 0 | 0 | 0 |
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| 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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