- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02355067
Social Media Intervention for Postpartum Depression
Social Media Intervention to Teach Parenting for Women With Postpartum Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postpartum depressive symptoms are common among women following the birth of a child and can adversely impact a mother's ability to care for her child. Evidence-based parent coaching programs have been developed to guide mothers with caring for their infants but do not address the effects of depression on parenting, can be expensive to administer, and are not available in a format that facilitates participation by women with depressive symptoms. We have adapted a previously validated parent coaching intervention, the Parents Interacting with Infants (PIWI) program, for use with depressed parents by inclusion of educational material based on Beardslee's cognitive psycho-educational family model. The program spans 8 weeks, each week focusing on a specific topic. The topics covered are: psychoeducation regarding depression and behavioral activation for coping with high levels of stress, sleep, play, laughter, feeding, temperament, safety, and reading with infants.
We will conduct a pilot randomized controlled trial comparing two versions of the parent coaching program: social media and traditional in-person group formats. We've modified the PIWI program to address barriers to participation through social media format using secret Facebook user groups. We will assess the feasibility and acceptability of the social media program compared to a traditional group format by examining the proportion of subjects who attend group sessions or "like" Facebook sessions. Women who consent to participate in the study will be assigned by randomization to one format or the other in blocks of 20.
Women will complete measures of feasibility and acceptability and measures of depressive symptoms, Beck Depression Inventory-II (BDI-II - Appendix 2) Scale and parenting competence, Parenting Sense of Competency (PSOC - Appendix 3 scales) prior to (time 0) and after the intervention (time 8-12 weeks post enrollment). In addition, mothers and infants in phase III will be videotaped during a 16-minute free play using a standardized measure of parenting interaction (PICCOLO) following completion of the intervention. The measures will provide important information on the effects of parent coaching formats on a new mother's depressive symptoms, her sense of parenting confidence, and her parenting interactions with her infant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Females
- 15 years of age or older at the start of the study
- English speaking
- Access to the internet via a computer or a smartphone
- Mother of a child 1-3 months old
- Edinburgh Postnatal Depression Scale (EPDS) score of 9 or higher
- Informed consent and HIPAA authorization.
Exclusion Criteria:
1) Have significant suicidal symptoms. Significant suicide risk is defined as current suicidal intent and a plan for suicidal behavior.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Social Media Format
Social Media Intervention for women with postpartum depression (PPD) symptoms
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These women will participate in the intervention through the online Facebook group.
|
|
Active Comparator: In-Person Format
Traditional In-Person Intervention for Women with postpartum depression (PPD)
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These women will participate in the intervention through a traditional weekly meeting of a group in-person.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance
Time Frame: 8 weeks
|
Percentage of participants who attend each group session or check in online weekly.
This is averaged over the course of the 8-week program.
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8 weeks
|
|
Acceptability
Time Frame: 12 weeks
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Participants report concerning their overall program effects-Satisfaction Questionnaire.
The scale ranges from 1-5 with higher values representing higher satisfaction.
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory (BDI-II)
Time Frame: 12 weeks
|
The BDI-II is a 21-item self-report tool that measures the severity of depression and includes two subscales: cognitive and somatic.
It has been well validated, with scores 14-19 indicating mild depression, 20-28 moderate depression, and 29-63 severe depression.
The full range of the BDI-II is 0-64.
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12 weeks
|
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Parenting Sense of Competency (PSOC) Scale
Time Frame: 12 weeks
|
The Parenting Sense of Competence scale measures parental competence on two dimensions: Satisfaction and Efficacy.
It is a 17 item Likert-scale questionnaire (on a 6 point scale ranging from strongly agree [1] to strongly disagree [6]), with nine questions under Satisfaction and seven under Efficacy.
Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role.
Higher scores represent better parenting sense of competency.
The full range of the score is 17-102.
|
12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: James P Guevara, MD, MPH, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-011491
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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