A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change from baseline maternal depressive symptoms at post-intervention
研究概览
简要总结
This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily preventive intervention.
详细描述
This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily intervention with previously demonstrated effectiveness improving maternal mental health and parenting stress in randomized controlled trials. vMP targets 5 core components: 1) enhancing social support; 2) attachment-based parenting education; 3) self-care, including affect regulation; 4) guided parent-child interactions, and 5) connecting to care. Eligible and enrolled participants will be randomized to receive the 10 week group-based intervention or 10 weeks of informational mailings; both groups will receive individual home-based sessions. Outcomes include maternal social support, psychopathology, sensitive parenting, child psychopathology, two-generational biobehavioral self-regulation targets (Respiratory Sinus Arrhythmia), parent and child emotion and behavior regulation, and dyadic behavioral and physiological synchrony. Assessments will occur at intake, post, and 6 months following the group.
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)
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrollment status in one of the following services: Supplemental Nutrition Assistance Program (SNAP), Family Independence Temporary Assistance Program (FITAP), Medicaid, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), or Head Start
- •Maternal age of at least 18 years
- •Mother is primary caregiver of child
- •Mother speaks English
- •Child age is between 3-5 years
- •Family resides within 8 parish New Orleans metro area
排除标准
- •Mother is not biological mother
- •Diagnosis of a heart condition in the mother or the child
- •Presence of a pacemaker in the mother or the child
- •Child diagnosis of autism or global developmental delay
- •Active maternal substance use
- •Active maternal psychosis
研究组 & 干预措施
Treatment
The experimental arm of Virtual Mom Power is a manualized multi-family group intervention consisting of 10, 90-minute virtual group + 2 individual sessions led by two co-facilitators. The curriculum includes 5 core components: (1) Attachment-Focused Parenting Education; (2) Self-Care; (3) Parenting Practice; (4) Social Support; & (5) Connection to Resources. Individual sessions combine motivational interviewing with MP core components and focus on identifying goals and barriers. We will work with mothers in individual coaching to problem-solve childcare and privacy during group time. Weekly between-group phone/text check-ins are also a part of the curriculum, used to strengthen connection, build trust, ensure safety, and assess basic needs. Data regarding attendance will be recorded and total dosage examined in treatment effects.
干预措施: Mom Power (Behavioral)
Informational control
The control arm of this study consists of two individual sessions with mothers, along with 10 weeks of virtual informational mailings. The mailings will contain Mom Power curriculum about attachment-based parenting and self-care. The individual sessions will focus on individual goal-setting related to parenting and reflection on the parent-child relationship. The control group does not include the components of social support, affect regulation skills coaching, or guided parent-child interaction that are part of the experimental arm.
干预措施: Mom Power Informational Mailing (Behavioral)
结局指标
主要结局
Change from baseline maternal depressive symptoms at post-intervention
时间窗: At completion of intervention, approximately 3 months
Mothers will report on their own depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) at baseline, post-intervention, and 6 month follow up; change in sum scale from baseline at post-intervention will be assessed. Higher scores reflect more depressive symptoms.
Change from baseline child behavior at post-intervention
时间窗: At completion of intervention, approximately 3 months
Mothers will report on child behavior on the Child Behavior Checklist (CBCL 1.5-5). Sum scores will be used. Higher scores reflect more behavior problems.
Change from baseline maternal depressive symptoms at 6 month follow up
时间窗: 6 months (follow up)
Mothers will report on their own depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) at baseline, post-intervention, and 6 month follow up; change in sum scale from baseline to 6 month follow up will be assessed. Higher scores reflect more depressive symptoms.
Change from baseline maternal posttraumatic stress symptoms at post-intervention
时间窗: At completion of intervention, approximately 3 months
Mothers will report on their own posttraumatic stress symptoms using the Posttraumatic Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5). Sum scales will be assessed at baseline, post-intervention (3 months), and 6 month follow up; change in sum scale from baseline to 3 month follow up will be assessed. Higher scores reflect more posttraumatic stress symptoms.
Change from baseline maternal posttraumatic stress symptoms at 6 month follow up
时间窗: 6 months (follow up)
Mothers will report on their own posttraumatic stress symptoms using the Posttraumatic Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5). Sum scales will be assessed at baseline, post-intervention (3 months), and 6 month follow up; change in sum scale from baseline to 6 month follow up will be assessed. Higher scores reflect more posttraumatic stress symptoms.
Change from baseline child behavior at 6 month follow up.
时间窗: 6 months (follow up)
Mothers will report on child behavior on the Child Behavior Checklist (CBCL 1.5-5). Sum scores will be used. Higher scores reflect more behavior problems.
次要结局
- Change in parenting stress from baseline to 6 month follow up(6 months)
- Change in parenting stress from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in self-report parent child relationship from baseline to follow up(6 months)
- Change in maternal social support from baseline to post intervention(At completion of intervention, approximately 3 months)
- Change in Working Models from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in maternal emotion regulation from baseline to follow up(6 months)
- Change in self-report parent child relationship from baseline to post intervention(At completion of intervention, approximately 3 months)
- Change in observed parenting sensitivity from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in maternal social support from baseline to follow up(6 months)
- Change in maternal emotion regulation from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in child Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in maternal emotion regulation while parenting from baseline to post intervention(At completion of intervention, approximately 3 months)
- Change in maternal emotion regulation while parenting from baseline to follow up(6 months)
- Change in maternal resting Respiratory Sinus Arrhythmia from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in maternal Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention(At completion of intervention, approximately 3 months)
- Change in child resting Respiratory Sinus Arrhythmia from baseline to post-intervention(At completion of intervention, approximately 3 months)
研究者
Sarah Gray
Associate Professor of Psychology, Clinical Professor of Psychiatry & Behavioral Sciences, Principal Investigator
Tulane University