NCT02355067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 2, 2019

Completed
Last Updated

March 9, 2021

Status Verified

February 1, 2021

Enrollment Period

2.8 years

First QC Date

January 30, 2015

Results QC Date

November 1, 2017

Last Update Submit

February 18, 2021

Conditions

Keywords

parentingpostpartum depressionmothersinfantsdepression

Outcome Measures

Primary Outcomes (2)

  • 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.

    8 weeks

  • Acceptability

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

    12 weeks

Secondary Outcomes (2)

  • Beck Depression Inventory (BDI-II)

    12 weeks

  • Parenting Sense of Competency (PSOC) Scale

    12 weeks

Study Arms (2)

Social Media Format

EXPERIMENTAL

Social Media Intervention for women with postpartum depression (PPD) symptoms

Behavioral: Social Media Intervention

In-Person Format

ACTIVE COMPARATOR

Traditional In-Person Intervention for Women with postpartum depression (PPD)

Behavioral: Traditional In-Person Intervention

Interventions

These women will participate in the intervention through the online Facebook group.

Social Media Format

These women will participate in the intervention through a traditional weekly meeting of a group in-person.

In-Person Format

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Females
  • 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.

You may not qualify if:

  • \) Have significant suicidal symptoms. Significant suicide risk is defined as current suicidal intent and a plan for suicidal behavior.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Depression, PostpartumDepression

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Results Point of Contact

Title
Dr. James Guevara
Organization
Children's Hospital of Philadelphia

Study Officials

  • James P Guevara, MD, MPH

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 4, 2015

Study Start

January 1, 2015

Primary Completion

November 3, 2017

Study Completion

November 3, 2017

Last Updated

March 9, 2021

Results First Posted

October 2, 2019

Record last verified: 2021-02

Locations