Efficacy of an Integrated Intervention to Treat Maternal Depression and Children's Behavior Problems: A Transactional Perspective
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
研究概览
简要总结
Maternal depression influences the development of children's behavior problems and vice versa; however most interventions singularly address maternal depression or children's behavior problems rather than both. This project assesses the efficacy of an intervention that treats both mothers and children in an integrated manner. Effects are expected to disrupt the reciprocal relations that perpetuate maternal and child mental health problems over time.
详细描述
The proposed project is a pilot randomized controlled trial to evaluate the effectiveness of an integrated intervention that dually treats maternal depressive symptoms and offspring behavior problems. Families (n = 40 mothers and their 2-to-4 year-old children) will be randomized to receive 10 sessions of ABC or 10 sessions of ABC+D in their home. ABC+D is an expanded version of ABC that additionally treats maternal depressive symptoms using Mothers and Babies adapted for mothers of toddlers. The specific aims of this proposed project are:
Aim 1. Collect preliminary data on the feasibility and acceptability of ABC+D in preparation for a small pilot randomized controlled trial (RCT).
Aim 2. Conduct a small pilot RCT to examine the effectiveness of ABC and ABC+D
Aim 3: Assess the overall acceptability (mother- and provider-rated), appropriateness (mother- and provider-rated), and feasibility (provider-rated) of ABC+D. Mothers will also rate their satisfaction with each session and the degree to which it was helpful, interesting, and comprehensible.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mothers 18 years of age or older with heightened depressive symptoms as determined by a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9)
- •Biological children (of mothers described above) between 2 and 4 years old with heightened behavior problems as determined by a score of at least 3 in at least 1 domain of functioning on the Impairment Rating Scales
- •English- or Spanish-speaking
排除标准
- •Self-reported history of psychosis or active suicidality as defined by self-report of a specific suicide plan or recent attempt
- •Child diagnosis of autism
研究组 & 干预措施
ABC
Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support
干预措施: Attachment and Biobehavioral Catch up (Behavioral)
ABC+D
Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping
干预措施: Attachment and Biobehavioral Catch up Plus Depression Treatment (Behavioral)
结局指标
主要结局
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
时间窗: Baseline to post-intervention. This is an anticipated average of 10 weeks.
Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms
Change in Early Childhood Screening Assessment score
时间窗: Baseline to post-intervention. This is an anticipated average of 10 weeks.
Scores range from 0 to 72 with higher values indicating more severe symptoms
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
时间窗: Baseline to post-intervention. This is approximately 10 weeks.
Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms
Change in Early Childhood Screening Assessment (ECSA) Score
时间窗: Baseline to post-intervention. This is approximately 10 weeks.
Scores range from 0 to 80 with higher values indicating more severe symptoms
次要结局
未报告次要终点