NCT05400161

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

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

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

First Submitted

Initial submission to the registry

May 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

November 18, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

2.4 years

First QC Date

May 27, 2022

Last Update Submit

July 17, 2025

Conditions

Keywords

Social MediaParentingPostpartum DepressionMothersInfantsChildhood Developmental OutcomesPostpartumDepressionMother-Infant Interactions

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 COMPARATOR

The 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.

Behavioral: MoodGym

Parenting Program + MoodGym

EXPERIMENTAL

The 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.

Behavioral: MoodGymBehavioral: Social Media-Based Parenting Program

Interventions

MoodGymBEHAVIORAL

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).

MoodGym AloneParenting Program + MoodGym

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.

Parenting Program + MoodGym

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Depression, PostpartumDepression

Condition Hierarchy (Ancestors)

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

Study Officials

  • James Guevara, MD,MPH

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
  • Rhonda Boyd, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

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

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
12 months after the end of the final year of funding.

Locations