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| Name | Class |
|---|---|
| The Oscar G. & Elsa S. Mayer Family Foundation | UNKNOWN |
| University of Pennsylvania | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Media Format | Experimental | Social Media Intervention for women with postpartum depression (PPD) symptoms |
|
| In-Person Format | Active Comparator | Traditional In-Person Intervention for Women with postpartum depression (PPD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Media Intervention | Behavioral | These women will participate in the intervention through the online Facebook group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Acceptability | Participants report concerning their overall program effects-Satisfaction Questionnaire. The scale ranges from 1-5 with higher values representing higher satisfaction. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
1) Have significant suicidal symptoms. Significant suicide risk is defined as current suicidal intent and a plan for suicidal behavior.
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| Name | Affiliation | Role |
|---|---|---|
| James P Guevara, MD, MPH | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | In-Person Format |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | percentage of participants | 8 weeks |
|
3 months from enrollment to second study visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Guevara | Children's Hospital of Philadelphia | 215-590-1130 | guevara@email.chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2015 | Oct 23, 2017 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2015 | Oct 23, 2017 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Traditional In-Person Intervention | Behavioral | These women will participate in the intervention through a traditional weekly meeting of a group in-person. |
|
| 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. | 12 weeks |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Beck Depression Inventory 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. | Mean | Full Range | units on a scale |
|
| Parenting Sense of Competency | Measures parental competence on 2 dimensions: Satisfaction and Efficacy. 17-item Likert-scale questionnaire (on a 6 point scale ranging from strongly agree [1] to strongly disagree [6]). Higher scores represent better parenting sense of competency. The full range of the score is 17-102. | Mean | Full Range | units on a scale |
|
|
|
| Primary | Acceptability | Participants report concerning their overall program effects-Satisfaction Questionnaire. The scale ranges from 1-5 with higher values representing higher satisfaction. | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
|
|
| 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. | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
|
|
| 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. | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |