Trials / Completed
CompletedNCT04045132
Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Children's Hospital of Philadelphia · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Postpartum depression (PPD) symptoms are common among women following the birth of a child and can adversely impact a mother's ability to care for her child. As a result, infants of mothers with PPD symptoms may experience less responsive parenting, placing them at greater risk for delays in development. Evidence- based parenting programs have been developed to guide mothers with caring for their infants but may not address the impact of depression on parenting, are intensive and expensive to administer with limited ability for scale up, or are not available in a format that facilitates participation by women with depressive symptoms. To address these barriers, we developed a theoretically-driven social media-based parenting program on responsive parenting and child development. To determine whether the social media-based parenting program can improve responsive parenting among women with PPD symptoms, we will conduct a prospective individually randomized group treatment trial. 75 eligible women who screen positive for PPD at their infants' well child visit and their children will be consented, enrolled, and randomized as mother-child dyads 1:1 to receive a) the social media-based parenting program plus online depression treatment or b) online depression treatment alone. We chose a randomized design, because it is most effective in guarding against bias and will ensure that patients in both arms are similar in observed and unobserved characteristics. Treatment assignment will be done at the time of enrollment following informed consent. Descriptive statistics for demographic and poverty characteristics and PPD symptoms measured at baseline will be examined across the two treatment groups to assess the success of the randomization. We will assess responsive parenting at baseline and 3 months post-enrollment. Secondary outcomes, including changes in EPDS, BDI-II PSOC, and PSI-SF scores measured between baseline and the 3-month follow-up between groups, will be explored to determine if the effects of the parenting program are consistent with preliminary pilot findings. The intervention arm will also be assessed with the Therapeutic Factors Inventory-8 (TFI-8) to measure cohesion and the Acceptability survey which measures feasibility of the parenting program at 3-months post-enrollment. Additionally, at the 3-month mark, all participants will be administered the MoodGym Acceptability Survey to assess feasibility of the online depression treatment program. The results of this application would be expected to contribute important new knowledge and inform a future trial on parenting strategies to better assist mothers with PPD symptoms and improve child developmental outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Social Media-Based Parenting Program | 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. |
| BEHAVIORAL | MoodGym | 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). |
Timeline
- Start date
- 2019-12-17
- Primary completion
- 2021-10-07
- Completion
- 2021-10-07
- First posted
- 2019-08-05
- Last updated
- 2023-12-27
- Results posted
- 2022-02-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04045132. Inclusion in this directory is not an endorsement.