Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms

NCT04045132 | Completed Results DMC

• 3 other identifiers: 19-016174R61MH11840519-016174-B
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a social media-based parenting program can improve responsive parenting among mothers with Postpartum depression (PPD) symptoms. Participants will be randomized to receive the parenting program plus online depression treatment or online depression treatment alone to assess target engagement. Our 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.

Conditions

Postpartum Depression; Parenting; Parent-Child Relations

Keywords

Social Media; Postpartum Depression; Parenting; Infants; Mothers

Outcome Measures

Primary Outcomes (1)

• The Parent Child Early Relational Assessment (PCERA)

  The Parent Child Early Relational Assessment (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 has been shown to possess good interrater reliability, internal consistency, discriminant and concurrent validity, and sensitivity to change. 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 indicates an area of strength.

  Baseline and 3 Months

Secondary Outcomes (9)

• The Edinburgh Postnatal Depression Scale (EPDS)

  Baseline, 1-month, 2-month, 3-month

• The Beck Depression Inventory (BDI-II)

  Baseline and 3-months

• The Parenting Sense of Competence Scale (PSOC)

  Baseline and 3 months

• The Parenting Stress Index-Short Form (PSI-SF)

  Baseline and 3 months

• The National Comorbidity Survey (NCS)

  1-month, 2-month, 3-month

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: Social Media-Based Parenting Program; Behavioral: MoodGym

Interventions

Social Media-Based Parenting Program BEHAVIORAL

Participants in the intervention group will be enrolled in Facebook secret user groups, administered by a trained facilitator, in order to permit participants to view and comment on posted materials. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes, narrated PowerPoint presentations, and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage). Women in the intervention group will also be enrolled in the online depression treatment program, MoodGym.

Parenting Program + MoodGym

MoodGym BEHAVIORAL

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. We 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 Alone; Parenting Program + MoodGym

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

First, the study occurred in a single urban geographic area with a predominantly African-American population. Second, the study occurred during the height of the COVID-19 Pandemic. Third, engagement with the PWD Program was lower than expected.

Results Point of Contact

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

guevara@chop.edu

2155901130

Study Officials

• James Guevara, MD, MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Rhonda Boyd, PhD

  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: 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: August 1, 2019
• First Posted: August 5, 2019
• Study Start: December 17, 2019
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: December 27, 2023
• Results First Posted: February 11, 2022

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after the end of the final year of funding.

Locations

US (1)