Postpartum DepressionNCT01967394
Social Media, Teen Moms and PPD
A study testing Use of internet based social marketing intervention and No use of social media in people with Postpartum Depression, run by University of Louisville at 8 sites in United States.
Trial summary
Approximately 400,000 live births occur to adolescents in the United States annually. Of the 50% of adolescent mothers who experience depressive symptoms, less than 25% comply with referrals for depression evaluation and treatment due to lack of knowledge of depression symptoms (literacy), negative attitude towards… Read more about this study
- Who is it for?
- Ages 13 to 21 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Use of internet based social marketing intervention and No use of social media
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 287 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent mothers, 13-21 years of age, who delivered a live child within the last 12 months, and has their baby residing with them. For the adolescent mothers enrolled in the Internet-based social marketing intervention, they must reside in Kentucky counties of Fayette, Jefferson, Bullitt, Henry, Oldham, Shelby, Spencer, Trimble, Christian, Warren or Barren. The adolescent mothers enrolled in the control group must reside in Kentucky counties of Campbell, Casey, Daviess, Boone, Nelson, Russell, Carroll, Kenton, Hardin, Hancock, Henderson, McClean, Meade, Ohio, Union, Webster, Meade or Marion
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Three Rivers
Carrollton, Kentucky, 41008
Hands Program of Kenton County (Young Families of Children, Inc)
Covington, Kentucky, 41011
Lincoln Trail Health Department
Elizabethtown, Kentucky, 42701
St. Joseph Hospital
Lexington, Kentucky
University of Louisville Hospital
Louisville, Kentucky
Hands Program of Boone and Campbell Counties (Every Child Succeeds)
Newport, Kentucky, 41072-0325
Three Rivers Health Department
Owensboro, Kentucky, 42303
Lake Cumberland Health Department
Somerset, Kentucky, 42501
About this study
Official title: Social Media, Teen Moms, and Postpartum Depression
Approximately 400,000 live births occur to adolescents in the United States annually. Of the 50% of adolescent mothers who experience depressive symptoms, less than 25% comply with referrals for depression evaluation and treatment due to lack of knowledge of depression symptoms (literacy), negative attitude towards mental health treatment, perception that individuals with depression are stigmatized (subjective norms), lack of understanding of health resources that are available to her and under her control (perceived control), and lack of time. Social media is a promising vehicle to reach and educate adolescent mothers since most adolescent mothers use social media for communication and to search for health information. Based upon the Theory of Planned Behavior, the investigators will target 11 counties in Kentucky with a social media ad campaign that will result in adolescent mothers (n=140) from those counties enrolling in an internet based intervention related to postpartum depression. The previously tested intervention includes vignettes from other adolescent mothers, questions and answers, resources, and an option to enroll in text message service. Before the intervention, after the intervention, and two weeks later the adolescent mothers will complete established questionnaires to determine if the intervention improved attitude and subjective norms towards depression and depression treatment, perceived control and intention related to seeking depression treatment, and the number of adolescent mothers with symptoms of depression who receive depression treatment. Data will be compared to scores on the same instruments from adolescent mothers (n=140) from the control group (18 other counties in Kentucky) that have not been targeted with the social media ad campaign or participated in the intervention. Data from the adolescent mothers in the control group will be collected in partnership with community agencies. The overall purpose of this trial is to test a cost effective and feasible method for reducing the cognitive and emotional barriers to accessing depression treatment in adolescent mothers. The specific aims are to (1) measure the extent to which a social media ad campaign is effective as a recruitment strategy; (2) test the effectiveness of an internet based social marketing intervention on both intention to seek treatment and rates of depression treatment, and (3) examine the dose effect of the intervention.
- Conditions
- Postpartum Depression
- Being tested
- Use of internet based social marketing intervention, No use of social media
- Keywords
- Health Care Quality, Access, Evaluation
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of internet based social marketing interventionOther
Eleven counties in Kentucky will be targeted with ads on Google and Facebook that direct adolescent mothers to an Internet-based social marketing intervention. The ads will be implemented using Facebook's and Google's ad network. The ads are setup, configured, and adjusted online. Facebook has identified key words that are recommended for adolescent mothers: "16 and pregnant," "teen mom,' and names of television shows with subject matter specific to adolescent mothers. We will target the ads to correspond to a geographical area that specifies a distance from the largest city in each county, and we will specify county lines. Ads will only appear on the Internet in the counties that are targeted for the intervention.
No use of social mediaOther
No social media ads will be available in these counties.
| Study group | Role | What they receive |
|---|---|---|
| Intervention County | Experimental | Use of internet based social marketing intervention Receives: Other: Use of internet based social marketing intervention |
| Control County | Placebo comparator | No use of social media Receives: Other: No use of social media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Social Marketing Intervention
How many teen mothers are enrolled in treatment programs for their depression per county? Is there a difference between counties?
Measured: 2 years
Secondary outcomes (1)
Number of teens seeking depression treatment
Do the teens in counties with the social media campaigns seek depression treatment more than those in the control counties.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Mimia Logsdon, University of Louisville
- Investigators
- Mimia C Logsdon, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967394
- Sponsor's protocol ID
- 1R15NR013563-01A1
- Other IDs
- R15NR013563
- Status last verified
- Dec 2015
- First submitted
- 10 Oct 2013
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Media, Teen Moms, and Postpartum Depression
- ClinicalTrials.gov ID
- NCT01967394
- Acronym / sponsor ID
- 1R15NR013563-01A1
- Conditions
- Postpartum Depression
- Keywords
- Health Care Quality, Access, Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 400,000 live births occur to adolescents in the United States annually. Of the 50% of adolescent mothers who experience depressive symptoms, less than 25% comply with referrals for depression evaluation and treatment due to lack of knowledge of depression symptoms (literacy), negative attitude towards mental health treatment, perception that individuals with depression are stigmatized (subjective norms), lack of understanding of health resources that are available to her and under her control (perceived control), and lack of time. Social media is a promising vehicle to reach and educate adolescent mothers since most adolescent mothers use social media for communication and to search for health information. Based upon the Theory of Planned Behavior, the investigators will target 11 counties in Kentucky with a social media ad campaign that will result in adolescent mothers (n=140) from those counties enrolling in an internet based intervention related to postpartum depression. The previously tested intervention includes vignettes from other adolescent mothers, questions and answers, resources, and an option to enroll in text message service. Before the intervention, after the intervention, and two weeks later the adolescent mothers will complete established questionnaires to determine if the intervention improved attitude and subjective norms towards depression and depression treatment, perceived control and intention related to seeking depression treatment, and the number of adolescent mothers with symptoms of depression who receive depression treatment. Data will be compared to scores on the same instruments from adolescent mothers (n=140) from the control group (18 other counties in Kentucky) that have not been targeted with the social media ad campaign or participated in the intervention. Data from the adolescent mothers in the control group will be collected in partnership with community agencies. The overall purpose of this trial is to test a cost effective and feasible method for reducing the cognitive and emotional barriers to accessing depression treatment in adolescent mothers. The specific aims are to (1) measure the extent to which a social media ad campaign is effective as a recruitment strategy; (2) test the effectiveness of an internet based social marketing intervention on both intention to seek treatment and rates of depression treatment, and (3) examine the dose effect of the intervention.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention County | Experimental | Other: Use of internet based social marketing interventionUse of internet based social marketing intervention |
| Control County | Placebo comparator | Other: No use of social mediaNo use of social media |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent mothers, 13-21 years of age, who delivered a live child within the last 12 months, and has their baby residing with them. For the adolescent mothers enrolled in the Internet-based social marketing intervention, they must reside in Kentucky counties of Fayette, Jefferson, Bullitt, Henry, Oldham, Shelby, Spencer, Trimble, Christian, Warren or Barren. The adolescent mothers enrolled in the control group must reside in Kentucky counties of Campbell, Casey, Daviess, Boone, Nelson, Russell, Carroll, Kenton, Hardin, Hancock, Henderson, McClean, Meade, Ohio, Union, Webster, Meade or Marion
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Use of internet based social marketing interventionEleven counties in Kentucky will be targeted with ads on Google and Facebook that direct adolescent mothers to an Internet-based social marketing intervention. The ads will be implemented using Facebook's and Google's ad network. The ads are setup, configured, and adjusted online. Facebook has identified key words that are recommended for adolescent mothers: "16 and pregnant," "teen mom,' and names of television shows with subject matter specific to adolescent mothers. We will target the ads to correspond to a geographical area that specifies a distance from the largest city in each county, and we will specify county lines. Ads will only appear on the Internet in the counties that are targeted for the intervention. | Other | Intervention County |
| No use of social mediaNo social media ads will be available in these counties. | Other | Control County |
Primary outcome
Effectiveness of Social Marketing Intervention
Time frame: 2 years
How many teen mothers are enrolled in treatment programs for their depression per county? Is there a difference between counties?
1 secondary outcome
Number of teens seeking depression treatment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
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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.
Mimia C Logsdon, PhD principal investigator
University of Louisville
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of internet based social marketing intervention and No use of social media in people with Postpartum Depression, run by University of Louisville at 8 sites 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 1 inclusion and 0 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 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effectiveness of Social Marketing Intervention (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2015.