Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The Parent Child Early Relational Assessment (PCERA)
研究概览
简要总结
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.
详细描述
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, BDI-II 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 and the Acceptability survey which measures feasibility of the parenting program at 3-months post-enrollment. Additionally, at the 3-month mark, all participants will be administered the MoodGym Acceptability Survey to assess feasibility of the online depression treatment program.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Video coders will be blinded to intervention assignment.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are >18 years old
- •Screen positive for postpartum depression (score>9) on the EPDS at a participating pediatric practice
- •Have an infant <8 months of age
- •Speak and Read English
- •Have Access to a smart phone or computer tablet with internet access
- •Children who:
- •Are < 8 months old
排除标准
- •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
研究组 & 干预措施
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.
干预措施: MoodGym (Behavioral)
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.
干预措施: Social Media-Based Parenting Program (Behavioral)
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.
干预措施: MoodGym (Behavioral)
结局指标
主要结局
The Parent Child Early Relational Assessment (PCERA)
时间窗: Baseline and 3 Months
The Parent 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. 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. Each individual subscale is scored between 0-5, with higher scores indicating more responsive parenting. A subscale score of 1-2 indicates an area of concern, a score of 3 indicates some concern, and a score of 4-5 indicates an area of strength.
次要结局
- MoodGym Acceptability Survey(3 months)
- The Parenting Sense of Competence Scale (PSOC)(Baseline and 3 months)
- The Parenting Stress Index-Short Form (PSI-SF)(Baseline and 3 months)
- Acceptability Survey(3 months)
- The National Comorbidity Survey (NCS)(1-month, 2-month, 3-month)
- Multi-dimensional Scale of Perceived Social Support (MSPSS)(Baseline)
- The Edinburgh Postnatal Depression Scale (EPDS)(Baseline, 1-month, 2-month, 3-month)
- The Beck Depression Inventory (BDI-II)(Baseline and 3-months)
- Therapeutic Factors Inventory (TFI-8)(3 months)
