Social Media Intervention for Postpartum Depression

February 18, 2021 updated by: Children's Hospital of Philadelphia

Social Media Intervention to Teach Parenting for Women With Postpartum Depression

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.

Study Overview

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

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Females
  2. 15 years of age or older at the start of the study
  3. English speaking
  4. Access to the internet via a computer or a smartphone
  5. Mother of a child 1-3 months old
  6. Edinburgh Postnatal Depression Scale (EPDS) score of 9 or higher
  7. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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)
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.
8 weeks
Acceptability
Time Frame: 12 weeks
Participants report concerning their overall program effects-Satisfaction Questionnaire. The scale ranges from 1-5 with higher values representing higher satisfaction.
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.
12 weeks
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: James P Guevara, MD, MPH, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

November 3, 2017

Study Completion (Actual)

November 3, 2017

Study Registration Dates

First Submitted

January 30, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 4, 2015

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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