Social Media Intervention for Postpartum Depression

• Sponsor: Children's Hospital of Philadelphia (Other)
• Overall Status: Completed
• CT.gov ID: NCT02355067
• Collaborator: The Oscar G. & Elsa S. Mayer Family Foundation (Other), University of Pennsylvania (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 34.1
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Depression; Parenting	Behavioral: Social Media Intervention; Behavioral: Traditional In-Person Intervention	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Social Media Intervention to Teach Parenting for Women With Postpartum Depression
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Nov 3, 2017
• Actual Study Completion Date: Nov 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Social Media Format Social Media Intervention for women with postpartum depression (PPD) symptoms	Behavioral: Social Media Intervention; 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)	Behavioral: Traditional In-Person Intervention; These women will participate in the intervention through a traditional weekly meeting of a group in-person.

Outcome Measures

Primary Outcome Measures

1. Attendance [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.

2. Acceptability [12 weeks]

   Participants report concerning their overall program effects-Satisfaction Questionnaire. The scale ranges from 1-5 with higher values representing higher satisfaction.

Secondary Outcome Measures

1. Beck Depression Inventory (BDI-II) [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.

2. Parenting Sense of Competency (PSOC) Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Children's Hospital of Philadelphia
• The Oscar G. & Elsa S. Mayer Family Foundation
• University of Pennsylvania

Investigators

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

Study Documents (Full-Text)

• Informed Consent Form - Sep 8, 2015
• Study Protocol and Statistical Analysis Plan - Sep 11, 2015

More Information

Publications

None provided.

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT02355067
• Other Study ID Numbers: 14-011491
• First Posted: Feb 4, 2015
• Last Update Posted: Mar 9, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Children's Hospital of Philadelphia: parenting; postpartum depression; mothers; infants; depression
• Additional relevant MeSH terms: Depression, Postpartum; Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Social Media Format	In-Person Format
Arm/Group Description	Social Media Intervention for women with postpartum depression (PPD) symptoms Social Media Intervention: These women will participate in the intervention through the online Facebook group.	Traditional In-Person Intervention for Women with postpartum depression (PPD) Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.
Period Title: Overall Study
STARTED	20	20
COMPLETED	12	12
NOT COMPLETED	8	8

Baseline Characteristics

Arm/Group Title	Social Media Format	In-Person Format	Total
Arm/Group Description	Social Media Intervention for women with postpartum depression (PPD) symptoms Social Media Intervention: These women will participate in the intervention through the online Facebook group.	Traditional In-Person Intervention for Women with postpartum depression (PPD) Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.	Total of all reporting groups
Overall Participants	12	12	24
Age (Count of Participants)
<=18 years	1 8.3%	1 8.3%	2 8.3%
Between 18 and 65 years	11 91.7%	11 91.7%	22 91.7%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.4 (1.9)	26.3 (1.8)	26.3 (1.9)
Sex: Female, Male (Count of Participants)
Female	12 100%	12 100%	24 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	9 75%	11 91.7%	20 83.3%
White	0 0%	1 8.3%	1 4.2%
More than one race	3 25%	0 0%	3 12.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	12 100%	12 100%	24 100%
Beck Depression Inventory II (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	30.7	25.7	28.2
Parenting Sense of Competency (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	67.8	78.3	73.0

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Social Media Format	In-Person Format
Arm/Group Description	Social Media Intervention for women with postpartum depression (PPD) symptoms Social Media Intervention: These women will participate in the intervention through the online Facebook group.	Traditional In-Person Intervention for Women with postpartum depression (PPD) Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.
Measure Participants	12	12
Mean (Full Range) [percentage of participants]	83.3 694.2%	3.3 27.5%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Social Media Format	In-Person Format
Arm/Group Description	Social Media Intervention for women with postpartum depression (PPD) symptoms Social Media Intervention: These women will participate in the intervention through the online Facebook group.	Traditional In-Person Intervention for Women with postpartum depression (PPD) Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.
Measure Participants	9	4
Mean (Full Range) [units on a scale]	4.5	4.5

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Social Media Format	In-Person Format
Arm/Group Description	Social Media Intervention for women with postpartum depression (PPD) symptoms Social Media Intervention: These women will participate in the intervention through the online Facebook group.	Traditional In-Person Intervention for Women with postpartum depression (PPD) Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.
Measure Participants	12	8
Mean (Full Range) [units on a scale]	20.2	23.3

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Social Media Format	In-Person Format
Arm/Group Description	Social Media Intervention for women with postpartum depression (PPD) symptoms Social Media Intervention: These women will participate in the intervention through the online Facebook group.	Traditional In-Person Intervention for Women with postpartum depression (PPD) Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.
Measure Participants	12	8
Mean (Full Range) [units on a scale]	76.3	73.6

Adverse Events

Time Frame	3 months from enrollment to second study visit
Arm/Group Title	Social Media Format		In-Person Format
Arm/Group Description	Social Media Intervention for women with postpartum depression (PPD) symptoms Social Media Intervention: These women will participate in the intervention through the online Facebook group.		Traditional In-Person Intervention for Women with postpartum depression (PPD) Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.
All Cause Mortality
	Social Media Format		In-Person Format
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Social Media Format		In-Person Format
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Social Media Format		In-Person Format
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.