Clinical trial NCT02355067: Social Media Intervention for Postpartum Depression
Official title: Social Media Intervention to Teach Parenting for Women With Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Parenting
Keywords: parenting
postpartum depression
mothers
infants
depression
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: The Oscar G. & Elsa S. Mayer Family Foundation
name: University of Pennsylvania
First posted: 2015-02-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is intended to compare the acceptability and feasibility and explore outcomes related to two different formats of a parenting program for mothers with postpartum depressive symptoms. One version will be a traditional, in-person group format, while the other will be a social media group format. The investigators will also explore the differences in outcomes of both formats, looking at depressive symptoms, parenting sense of competency, and parenting interactions with children.

Detailed description: Postpartum depressive symptoms are common among women following the birth of a child and can adversely impact a mother's ability to care for her child. Evidence-based parent coaching programs have been developed to guide mothers with caring for their infants but do not address the effects of depression on parenting, can be expensive to administer, and are not available in a format that facilitates participation by women with depressive symptoms. We have adapted a previously validated parent coaching intervention, the Parents Interacting with Infants (PIWI) program, for use with depressed parents by inclusion of educational material based on Beardslee's cognitive psycho-educational family model. The program spans 8 weeks, each week focusing on a specific topic. The topics covered are: psychoeducation regarding depression and behavioral activation for coping with high levels of stress, sleep, play, laughter, feeding, temperament, safety, and reading with infants.

We will conduct a pilot randomized controlled trial comparing two versions of the parent coaching program: social media and traditional in-person group formats. We've modified the PIWI program to address barriers to participation through social media format using secret Facebook user groups. We will assess the feasibility and acceptability of the social media program compared to a traditional group format by examining the proportion of subjects who attend group sessions or "like" Facebook sessions. Women who consent to participate in the study will be assigned by randomization to one format or the other in blocks of 20.

Women will complete measures of feasibility and acceptability and measures of depressive symptoms, Beck Depression Inventory-II (BDI-II - Appendix 2) Scale and parenting competence, Parenting Sense of Competency (PSOC - Appendix 3 scales) prior to (time 0) and after the intervention (time 8-12 weeks post enrollment). In addition, mothers and infants in phase III will be videotaped during a 16-minute free play using a standardized measure of parenting interaction (PICCOLO) following completion of the intervention. The measures will provide important information on the effects of parent coaching formats on a new mother's depressive symptoms, her sense of parenting confidence, and her parenting interactions with her infant.

Eligibility criteria: Inclusion Criteria:

1. Females
2. 15 years of age or older at the start of the study
3. English speaking
4. Access to the internet via a computer or a smartphone
5. Mother of a child 1-3 months old
6. Edinburgh Postnatal Depression Scale (EPDS) score of 9 or higher
7. Informed consent and HIPAA authorization.

Exclusion Criteria:

1) Have significant suicidal symptoms. Significant suicide risk is defined as current suicidal intent and a plan for suicidal behavior.

Primary outcomes:
measure: Attendance
timeFrame: 8 weeks
measure: Acceptability
timeFrame: 12 weeks
Secondary outcomes:
measure: Beck Depression Inventory (BDI-II)
timeFrame: 12 weeks
measure: Parenting Sense of Competency (PSOC) Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: James P Guevara, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: