Social Media Intervention for Postpartum Depression
Primary Purpose
Postpartum Depression, Parenting
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Media Intervention
Traditional In-Person Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Postpartum Depression focused on measuring parenting, postpartum depression, mothers, infants, depression
Eligibility Criteria
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.
Sites / Locations
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Social Media Format
In-Person Format
Arm Description
Social Media Intervention for women with postpartum depression (PPD) symptoms
Traditional In-Person Intervention for Women with postpartum depression (PPD)
Outcomes
Primary Outcome Measures
Attendance
Percentage of participants who attend each group session or check in online weekly. This is averaged over the course of the 8-week program.
Acceptability
Participants report concerning their overall program effects-Satisfaction Questionnaire. The scale ranges from 1-5 with higher values representing higher satisfaction.
Secondary Outcome Measures
Beck Depression Inventory (BDI-II)
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.
Parenting Sense of Competency (PSOC) Scale
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.
Full Information
NCT ID
NCT02355067
First Posted
January 30, 2015
Last Updated
February 18, 2021
Sponsor
Children's Hospital of Philadelphia
Collaborators
The Oscar G. & Elsa S. Mayer Family Foundation, University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02355067
Brief Title
Social Media Intervention for Postpartum Depression
Official Title
Social Media Intervention to Teach Parenting for Women With Postpartum Depression
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 3, 2017 (Actual)
Study Completion Date
November 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
The Oscar G. & Elsa S. Mayer Family Foundation, University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is intended to compare the acceptability and feasibility and explore outcomes related to two different formats of a parenting program for mothers with postpartum depressive symptoms. One version will be a traditional, in-person group format, while the other will be a social media group format. The investigators will also explore the differences in outcomes of both formats, looking at depressive symptoms, parenting sense of competency, and parenting interactions with children.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Parenting
Keywords
parenting, postpartum depression, mothers, infants, depression
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social Media Format
Arm Type
Experimental
Arm Description
Social Media Intervention for women with postpartum depression (PPD) symptoms
Arm Title
In-Person Format
Arm Type
Active Comparator
Arm Description
Traditional In-Person Intervention for Women with postpartum depression (PPD)
Intervention Type
Behavioral
Intervention Name(s)
Social Media Intervention
Intervention Description
These women will participate in the intervention through the online Facebook group.
Intervention Type
Behavioral
Intervention Name(s)
Traditional In-Person Intervention
Intervention Description
These women will participate in the intervention through a traditional weekly meeting of a group in-person.
Primary Outcome Measure Information:
Title
Attendance
Description
Percentage of participants who attend each group session or check in online weekly. This is averaged over the course of the 8-week program.
Time Frame
8 weeks
Title
Acceptability
Description
Participants report concerning their overall program effects-Satisfaction Questionnaire. The scale ranges from 1-5 with higher values representing higher satisfaction.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI-II)
Description
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.
Time Frame
12 weeks
Title
Parenting Sense of Competency (PSOC) Scale
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James P Guevara, MD, MPH
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Social Media Intervention for Postpartum Depression
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