Clinical trial NCT04045132: Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms
Official title: Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Parenting
Parent-Child Relations
Keywords: Social Media
Postpartum Depression
Parenting
Infants
Mothers
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-08-05
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The Parent Child Early Relational Assessment (PCERA)
timeFrame: Baseline and 3 Months
Secondary outcomes:
measure: The Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline, 1-month, 2-month, 3-month
measure: The Beck Depression Inventory (BDI-II)
timeFrame: Baseline and 3-months
measure: The Parenting Sense of Competence Scale (PSOC)
timeFrame: Baseline and 3 months
measure: The Parenting Stress Index-Short Form (PSI-SF)
timeFrame: Baseline and 3 months
measure: The National Comorbidity Survey (NCS)
timeFrame: 1-month, 2-month, 3-month
measure: Multi-dimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline
measure: Therapeutic Factors Inventory (TFI-8)
timeFrame: 3 months
measure: Acceptability Survey
timeFrame: 3 months
measure: MoodGym Acceptability Survey
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: James Guevara, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Rhonda Boyd, PhD
role: PRINCIPAL_INVESTIGATOR
References: