Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02355067 |
Other study ID # |
14-011491 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2015 |
Est. completion date |
November 3, 2017 |
Study information
Verified date |
February 2021 |
Source |
Children's Hospital of Philadelphia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.