Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

The Parenting With Depression Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04045132
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
The purpose of this study is to determine whether a social media-based parenting program can improve responsive parenting among mothers with Postpartum depression (PPD) symptoms. Participants will be randomized to receive the parenting program plus online depression treatment or online depression treatment alone to assess target engagement. Our overall objective for this application is to study whether this program combined with online depression treatment leads to more responsive parenting (target) and signals improved child language, socioemotional and cognitive development (outcomes) compared to depression treatment alone.

Condition or disease Intervention/treatment Phase
Postpartum Depression Parenting Parent-Child Relations Behavioral: Social Media-Based Parenting Program Behavioral: MoodGym Not Applicable

Detailed Description:

Postpartum depression (PPD) symptoms are common among women following the birth of a child and can adversely impact a mother's ability to care for her child. As a result, infants of mothers with PPD symptoms may experience less responsive parenting, placing them at greater risk for delays in development. Evidence- based parenting programs have been developed to guide mothers with caring for their infants but may not address the impact of depression on parenting, are intensive and expensive to administer with limited ability for scale up, or are not available in a format that facilitates participation by women with depressive symptoms. To address these barriers, we developed a theoretically-driven social media-based parenting program on responsive parenting and child development.

To determine whether the social media-based parenting program can improve responsive parenting among women with PPD symptoms, we will conduct a prospective individually randomized group treatment trial. 75 eligible women who screen positive for PPD at their infants' well child visit and their children will be consented, enrolled, and randomized as mother-child dyads 1:1 to receive a) the social media-based parenting program plus online depression treatment or b) online depression treatment alone. We chose a randomized design, because it is most effective in guarding against bias and will ensure that patients in both arms are similar in observed and unobserved characteristics. Treatment assignment will be done at the time of enrollment following informed consent.

Descriptive statistics for demographic and poverty characteristics and PPD symptoms measured at baseline will be examined across the two treatment groups to assess the success of the randomization. We will assess responsive parenting at baseline and 3 months post-enrollment. Secondary outcomes, including changes in EPDS, PSOC, and PSI-SF scores measured between baseline and the 3-month follow-up between groups, will be explored to determine if the effects of the parenting program are consistent with preliminary pilot findings. The intervention arm will also be assessed with the Therapeutic Factors Inventory-8 (TFI-8) to measure cohesion at 3-months post-enrollment.

The results of this application would be expected to contribute important new knowledge and inform a future trial on parenting strategies to better assist mothers with PPD symptoms and improve child developmental outcomes.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Video coders will be blinded to intervention assignment.
Primary Purpose: Treatment
Official Title: Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MoodGym Alone
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
Behavioral: MoodGym
Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).

Experimental: Parenting Program + MoodGym
The social media-based parenting program consists of 8 weekly sessions using a Facebook platform with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Behavioral: Social Media-Based Parenting Program
Participants in the intervention group will be enrolled in Facebook secret user groups, administered by a trained facilitator, in order to permit participants to view and comment on posted materials. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes, narrated PowerPoint presentations, and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage). Women in the intervention group will also be enrolled in the online depression treatment program, MoodGym.

Behavioral: MoodGym
Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).




Primary Outcome Measures :
  1. Measure the quality of affect and behavior in parent-child interactions [ Time Frame: 3 Months ]
    The Patient Child Early Relational Assessment (PCERA) is a validated 65-item videotape assessment designed to measure the quality of affect and behavior in parent-infant interactions. The PCERA uses ratings that are based on observations of 5-minute videotaped interactions with parent-infant dyads engaged in free play at a research lab at the Children's Hospital of Philadelphia (CHOP). The PCERA has been shown to possess good interrater reliability, internal consistency, discriminant and concurrent validity, and sensitivity to change. The PCERA contains 8 subscales of which 3 parenting subscales will be the focus: 1) Parental Positive Affective Involvement and Verbalization, 2) Parental Negative Affect and Behavior, and 3) Parental Intrusiveness, Insensitivity, and Inconsistency. Administration and coding will follow the PCERA manual. Higher scores indicate more responsive parenting.


Secondary Outcome Measures :
  1. Change in depressive symptoms [ Time Frame: 3 months ]
    The Edinburgh Postnatal Depression Scale (EPDS) is a validated 10-item self-report measure of depressive symptoms with strong evidence for reliability, validity, and utility in varying populations. It has been used extensively in mental health research and provides cutpoints to determine the severity of depressive symptoms. It includes a question on suicidal thoughts and wishes (#10) that will be used to monitor for suicidality. The total score will be used with scores of 10 or higher representing minor or moderate depression and scores of 20 or greater representing severe depression.This outcome will assess changes in EPDS from baseline to 3 months.

  2. Change in parenting self-esteem and confidence [ Time Frame: 3 months ]
    The Parenting Sense of Competence Scale (PSOC) is a validated 17-item self-report measure of parenting self-esteem and competence and consists of two factors: satisfaction and efficacy. Response categories are on a 6-point likert-scale from strongly disagree to strongly agree. The total score (which includes the sum of the two factors) will be used. A higher score indicates a higher parenting sense of competency. There are no average scores or 'cut-off's' for this tool. This outcomes will assess changes in PSOC from baseline to 3 months.

  3. Change in parenting stress [ Time Frame: 3 months ]
    The Parenting Stress Index-Short Form (PSI-SF) is a validated 36-item scale that measures parenting stress. The PSI-SF is a direct derivative of the full-length test (PSI) and it has been shown to have excellent internal consistency and to be positively associated with maternal psychological distress. Scores on the PSI-SF correlate well with the full-length PSI. It yields a Total Stress score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The total score will be used, with higher scores indicating higher levels of stress.This outcomes will assess changes in PSI-SF from baseline to 3 months.

  4. Mental health service use [ Time Frame: 3 months ]
    The National Comorbidity Survey (NCS) provides data on mental health treatment in the United States. We will include a question from the NCS on prior mental health services use in the past month: "In the past month, did you receive treatment for problems with your emotions or nerves, or your use of alcohol or drugs?" We will consider mental health service use to have occurred in the past month if a mother responds affirmatively to this question. We will determine total months of mental health service use (0-3).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women who:

  • Are >18 years old
  • Screen positive for postpartum depression (score>9) on the EPDS at a participating pediatric practice
  • Have an infant <6 months of age
  • Speak and Read English
  • Have Access to a smart phone or computer tablet with internet access

Children who:

  • Are < 6months old

Exclusion Criteria:

Women who:

  • Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) at enrollment.
  • Report severe depressive symptoms (EPDS>20) at enrollment.
  • Have a substantiated report of child maltreatment

Children who:

  • Were born premature (estimated gestational age<35 weeks)
  • Have been diagnosed with congenital malformations or genetic syndromes which place them at risk of developmental delays
  • Are already currently receiving early intervention services for developmental delays at baseline

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): NCT04045132


Contacts
Layout table for location contacts
Contact: James Guevara, MD, MPH 215-590-1130 guevara@email.chop.edu
Contact: Talia Charidah, MPH 267-426-7947 charidaht@email.chop.edu

Locations
Layout table for location information
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: James Guevara, MD,MPH    215-590-1130    guevara@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institute of Mental Health (NIMH)

Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04045132    
Other Study ID Numbers: 19-016174
R61MH118405 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A complete, cleaned, and de-identified dataset will be made available to other investigators after all analyses have been conducted and within twelve months of the end of the final year of funding to allow for publication of all study aims. To obtain this data set, other investigators will need to contact the study Principal Investigator (PI) who will provide a data sharing agreement. The data sharing agreement will permit a deidentified data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available on a Compact Disc Read-Only Memory (CD-ROM) or through a secure File Transfer Protocol (FTP) site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 12 months after the end of the final year of funding.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
Social Media
Postpartum Depression
Parenting
Infants
Mothers
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications