Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms: Impact on Child Development
2 other identifiers
interventional
95
1 country
1
Brief Summary
The long-term goal is to develop effective parenting strategies to facilitate optimal child development for mothers suffering with PPD symptoms. The overall objective for this application is to study whether this program combined with online depression treatment leads to more responsive parenting (target) and signals improved child language, socioemotional and cognitive development (outcomes) compared to depression treatment alone. Findings from this application can be used to inform a future study to test the effectiveness and implementation of this social media-based parenting program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
November 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2025
CompletedJuly 22, 2025
July 1, 2025
2.4 years
May 27, 2022
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in parent-child interactions
The Parent Child Early Relational Assessment (PCERA) will be used to assess parent-child interactions. The PCERA is a validated 65-item videotape assessment designed to measure the quality of affect and behavior in parent-infant interactions. The PCERA uses ratings that are based on observations of 5-minute videotaped interactions with parent-infant dyads engaged in free play. The PCERA contains 8 subscales of which 3 parenting subscales will be the focus: 1) Parental Positive Affective Involvement and Verbalization, 2) Parental Negative Affect and Behavior, and 3) Parental Intrusiveness, Insensitivity, and Inconsistency. Each individual subscale is scored between 0-5, with higher scores indicating more responsive parenting. A subscale score of 1-2 indicates an area of concern, a score of 3 indicates some concern, and a score of 4-5 in
Baseline and 3-months
Secondary Outcomes (9)
Changes in severity of depressive symptoms
Monthly (Baseline to 12-months)
Changes in parenting competence
Baseline and 3-months
Changes in parenting stress
Baseline and 3-months
Prior mental health service use
Monthly (Baseline to 12-months)
Social support
Baseline
- +4 more secondary outcomes
Study Arms (2)
MoodGym Alone
ACTIVE COMPARATORThe MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
Parenting Program + MoodGym
EXPERIMENTALThe social media-based parenting program consists of 8 weekly sessions using a Facebook platform with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Interventions
Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. Investigators will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
Participants in the intervention group will be enrolled in Facebook secret user groups, administered by a trained facilitator, to permit participants to view and comment on posted materials. Content and user identity are restricted to invited participants to maintain privacy. Investigators will organize educational materials into video vignettes, narrated PowerPoint presentations, and written materials. The facilitator reviews and comments on postings daily and provides feedback to participants. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed and counts of sessions viewed and comments posted. Participants randomized to the intervention will also have the option to take part in a preliminary virtual session through a secure video platform (e.g. BlueJeans) and will receive weekly engagement text messages. Women in the intervention group will be enrolled in the online depression treatment program, MoodGym.
Eligibility Criteria
You may qualify if:
- Women who:
- Are \>18 years old
- Screen positive for postpartum depression (score\>9) on the EPDS at a -participating pediatric practice
- Have an infant \<8 months of age
- Speak and Read English
- Have Access to a smart phone or computer tablet with internet access
- Children who:
- Are \< 8 months old
You may not qualify if:
- Women who:
- Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) at enrollment.
- Report severe depressive symptoms (EPDS\>20) at enrollment.
- Have a substantiated report of child maltreatment
- Children who:
- Were born premature (estimated gestational age\<35 weeks)
- Have been diagnosed with congenital malformations or genetic syndromes which place them at risk of developmental delays
- Are already currently receiving early intervention services for developmental delays at baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Guevara, MD,MPH
Children's Hospital of Philadelphia
- PRINCIPAL INVESTIGATOR
Rhonda Boyd, PhD
Children's Hospital of Philadelphia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Video coders will be blinded to intervention assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 1, 2022
Study Start
November 18, 2022
Primary Completion
April 14, 2025
Study Completion
April 14, 2025
Last Updated
July 22, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 12 months after the end of the final year of funding.
A complete, cleaned, and de-identified dataset will be made available to other investigators after all analyses have been conducted and within twelve months of the end of the final year of funding to allow for publication of all study aims. To obtain this data set, other investigators will need to contact the study Principal Investigator (PI) who will provide a data sharing agreement. The data sharing agreement will permit a deidentified data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available on a Compact Disc Read-Only Memory (CD-ROM) or through a secure File Transfer Protocol (FTP) site.