Parenting, Postpartum Depression
Conditions
Keywords
parenting, postpartum depression, mothers, infants, depression
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.
Interventions
BEHAVIORALSocial Media Intervention
These women will participate in the intervention through the online Facebook group.
BEHAVIORALTraditional In-Person Intervention
These women will participate in the intervention through a traditional weekly meeting of a group in-person.
Sponsors
The Oscar G. & Elsa S. Mayer Family Foundation
University of Pennsylvania
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance | 8 weeks | Percentage of participants who attend each group session or check in online weekly. This is averaged over the course of the 8-week program. |
| Acceptability | 12 weeks | Participants report concerning their overall program effects-Satisfaction Questionnaire. The scale ranges from 1-5 with higher values representing higher satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory (BDI-II) | 12 weeks | The BDI-II is a 21-item self-report tool that measures the severity of depression and includes two subscales: cognitive and somatic. It has been well validated, with scores 14-19 indicating mild depression, 20-28 moderate depression, and 29-63 severe depression. The full range of the BDI-II is 0-64. |
| Parenting Sense of Competency (PSOC) Scale | 12 weeks | The Parenting Sense of Competence scale measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 17 item Likert-scale questionnaire (on a 6 point scale ranging from strongly agree \[1\] to strongly disagree \[6\]), with nine questions under Satisfaction and seven under Efficacy. Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role. Higher scores represent better parenting sense of competency. The full range of the score is 17-102. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Social Media Format Social Media Intervention for women with postpartum depression (PPD) symptoms
Social Media Intervention: These women will participate in the intervention through the online Facebook group. | 12 |
| In-Person Format Traditional In-Person Intervention for Women with postpartum depression (PPD)
Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Social Media Format | Total | In-Person Format |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 22 Participants | 11 Participants |
| Age, Continuous | 26.4 years STANDARD_DEVIATION 1.9 | 26.3 years STANDARD_DEVIATION 1.9 | 26.3 years STANDARD_DEVIATION 1.8 |
| Beck Depression Inventory II | 30.7 units on a scale | 28.2 units on a scale | 25.7 units on a scale |
| Parenting Sense of Competency | 67.8 units on a scale | 73.0 units on a scale | 78.3 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 20 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 12 Participants | 24 Participants | 12 Participants |
| Sex: Female, Male Female | 12 Participants | 24 Participants | 12 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Acceptability
Participants report concerning their overall program effects-Satisfaction Questionnaire. The scale ranges from 1-5 with higher values representing higher satisfaction.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Social Media Format | Acceptability | 4.5 units on a scale |
| In-Person Format | Acceptability | 4.5 units on a scale |
Primary
Attendance
Percentage of participants who attend each group session or check in online weekly. This is averaged over the course of the 8-week program.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Social Media Format | Attendance | 83.3 percentage of participants |
| In-Person Format | Attendance | 3.3 percentage of participants |
Secondary
Beck Depression Inventory (BDI-II)
The BDI-II is a 21-item self-report tool that measures the severity of depression and includes two subscales: cognitive and somatic. It has been well validated, with scores 14-19 indicating mild depression, 20-28 moderate depression, and 29-63 severe depression. The full range of the BDI-II is 0-64.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Social Media Format | Beck Depression Inventory (BDI-II) | 20.2 units on a scale |
| In-Person Format | Beck Depression Inventory (BDI-II) | 23.3 units on a scale |
Secondary
Parenting Sense of Competency (PSOC) Scale
The Parenting Sense of Competence scale measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 17 item Likert-scale questionnaire (on a 6 point scale ranging from strongly agree \[1\] to strongly disagree \[6\]), with nine questions under Satisfaction and seven under Efficacy. Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role. Higher scores represent better parenting sense of competency. The full range of the score is 17-102.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Social Media Format | Parenting Sense of Competency (PSOC) Scale | 76.3 units on a scale |
| In-Person Format | Parenting Sense of Competency (PSOC) Scale | 73.6 units on a scale |