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Trial record 56 of 256 for:    postpartum | "Depression"

Social Media Intervention for Postpartum Depression

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ClinicalTrials.gov Identifier: NCT02355067
Recruitment Status : Active, not recruiting
First Posted : February 4, 2015
Last Update Posted : January 4, 2017
Sponsor:
Collaborators:
The Oscar G. & Elsa S. Mayer Family Foundation
University of Pennsylvania
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Parenting Behavioral: Social Media Intervention Behavioral: Traditional In-Person Intervention Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Social Media Intervention to Teach Parenting for Women With Postpartum Depression
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Social Media Format
Social Media Intervention for women with postpartum depression (PPD) symptoms
Behavioral: Social Media Intervention
These women will participate in the intervention through the online Facebook group.

Active Comparator: In-Person Format
Traditional In-Person Intervention for Women with postpartum depression (PPD)
Behavioral: Traditional In-Person Intervention
These women will participate in the intervention through a traditional weekly meeting of a group in-person.




Primary Outcome Measures :
  1. Feasibility (Percentage of participants who attend each group session or check in online weekly) [ Time Frame: 12 weeks ]
    Percentage of participants who attend each group session or check in online weekly

  2. Acceptability (Percentage of participants who report they agree or strongly agree with statements concerning program effects-Satisfaction Questionnaire) [ Time Frame: 12 weeks ]
    Percentage of participants who report they agree or strongly agree with statements concerning program effects-Satisfaction Questionnaire


Secondary Outcome Measures :
  1. Beck Depression Inventory (BDI-II) [ Time Frame: 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.

  2. Parenting Sense of Competency (PSOC) scale [ Time Frame: 12 weeks ]
    The Parenting Sense of Competence scale measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 16 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.

  3. Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) [ Time Frame: 12 weeks ]
    The Parenting Interactions with Children: Checklist of Observations Linked to Outcomes is a checklist of 29 observable developmentally supportive parenting behaviors with children ages 10-47 months in four domains: affection, responsiveness, encouragement, and teaching. It is a positive, practical, versatile, culturally sensitive, valid, and reliable tool for practitioners that shows what parents can do to support their children's development. Currently, the PICCOLO is being validated for infants down to 6 months of age.

  4. Therapeutic Factors Inventory - 8 [ Time Frame: 12 weeks ]
    The Therapeutic Factors Inventory-8 is a brief version of the 23-item Therapeutic Factors Inventory-Short Form (TFI-S), based on the Therapeutic Factors Inventory, initially developed to assess group psychotherapy factors, the key mechanisms by which change occurs in all types of therapy groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355067


Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
The Oscar G. & Elsa S. Mayer Family Foundation
University of Pennsylvania
Investigators
Principal Investigator: James P Guevara, MD, MPH Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02355067     History of Changes
Other Study ID Numbers: IRB 14-011491
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017

Keywords provided by Children's Hospital of Philadelphia:
parenting
postpartum depression
mothers
infants
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications