Family Nurture Intervention, A Group Model: Short and Long Term Effects on Behavior and Development of Preschool Aged Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Change in Childhood Behavior Checklist (CBCL) Score
研究概览
简要总结
The purpose of this current study is to investigate the efficacy of a group model of Family Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders. The investigator hypothesizes that the children who are treated with Family Nurture Intervention (FNI), which incorporates interactive touch with vocal soothing, and family practice in comforting, will show increased emotional connection and mother child co-regulation with better results in the outcome measures in the short term and long term.
详细描述
There are several early intervention programs that are available for children with emotional, behavioral and developmental disorders, ranging from behavioral treatment and sensory exposure therapy to pharmaceutical treatments. Although improvements in behavior have resulted from these interventions, they are limited in numerous ways. They are usually time-consuming, both for the child and the teacher or clinician providing the intervention. In order to see an effect of the intervention, most children must engage in the intervention procedure for several years. Moreover, the effects of most current intervention procedures are minimal to moderate. Pharmaceutical prescriptions are often accompanied by undesirable side effects that may modulate behavior, emotion, and physiological functions. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 24 Months 至 54 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is a singleton
- •Mother can speak in English or Spanish
- •Child is between the ages of 2 to 4 ½ years at date of enrollment
- •Mother is 18 years of age or older at the time of consent
- •Child demonstrates developmental deficit as measured by the SDQ (cutoff of 13 or more on the total score excluding the pro-social questions; OR 4 or less on the pro-social questions, which are reverse scored i.e. higher is better)
- •Child must reside with mother
排除标准
- •The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral Palsy
- •The child has a diagnosis of Autism
- •The child has severe motor or physical disability
- •Mother currently presents with psychosis or is currently taking antipsychotic medication
- •Current maternal drug and/or alcohol abuse
- •Mother has any current involvement with Child Protective Services (Department of Children and Families)
- •Mother is pregnant
- •Mother and/or infant has a medical condition or contagion that precludes intervention components
结局指标
主要结局
Change in Childhood Behavior Checklist (CBCL) Score
时间窗: Baseline, 6 months
The Childhood Behavior Checklist (CBCL) is a device by which parents or other individuals who know the child well rate a child's problem behaviors and competencies. This instrument can either be self-administered or administered through an interview. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The first section of this questionnaire consists of 20 competence items and the second section consists of 120 items on behavior or emotional problems.
次要结局
- Co-regulation of Vagal Tone(Up to 12 months)
- Change in Maternal Anxiety and Depressive Symptoms(Up to 12 months)
- Changes in Welch Emotional Connection Scale(Up to 12 months)
研究者
Martha G Welch
Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)
Columbia University