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临床试验/NCT02123160
NCT02123160终止1 期

Dyadic Therapy for Mothers and Children

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年11月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
终止
入组人数
2
试验地点
1
主要终点
Change in Maternal Symptoms of Depression (Beck Depression Inventory)

研究概览

简要总结

This study compares the effectiveness of Child Parent Psychotherapy to that of usual care (defined as: referral to therapists in the community or Columbia University Medical Center) in improving maternal depressive symptoms and child emotional and behavioral disturbances. The investigators will recruit mothers who report being mildly to moderately depressed and their preschoolers (ages 3-5 years) who they are concerned are exhibiting emotional and/or behavioral problems.

详细描述

Child Parent Psychotherapy (CPP) has been demonstrated to be effective in improving mother-child attachment relationship, maternal (depression, posttraumatic stress symptoms, global symptoms of distress) and child (behavior problems, posttraumatic stress symptoms and diagnosis, cognitive and representational models) outcomes, in the context of risk factors such as maternal depression and exposure to traumatic events. It is the only treatment for preschool aged children and caregivers that seeks to affect changes at both behavioral and schematic/ cognitive levels. The investigators aim to assess the feasibility and acceptability of providing CPP as a dyadic preventive intervention for children who are displaying signs of emotional and behavioral difficulties in the context of maternal depression.

Investigators will compare the effectiveness of CPP to that of usual care (usual care defined as: referral to therapists in the community and within Columbia University Medical Center for psychoeducation, counseling/ therapy for maternal depressive symptoms, and child behavioral/ emotional difficulties) in improving maternal depressive symptoms and child emotional and behavioral problems. The investigators will recruit mothers who report being mildly to moderately depressed and their preschoolers (aged 3-5 years) who they are concerned are exhibiting emotional and/or behavioral problems.

Mother-child patient dyads will be screened via telephone to assess study eligibility. If eligible mothers and their children will complete an in-person pre-treatment assessment. After the Time 1 (pre-treatment) assessment, mother-child patient dyads will be randomly assigned to one of two treatment conditions - 1. six months of weekly CPP intervention sessions OR 2. control condition in which mothers and their children will be referred for usual treatment in the community. Random assignment will be done based on a pre-determined schedule (a random number generator will be used to create a schedule for patient treatment assignment). Following randomization mother-child patient dyads will complete the following assessments: Time 2 (after 12 sessions or an average of three months), Time 3 (after 24 sessions or an average of six months), and Time 4 (six months after 24 treatment sessions or an average of one year after Time 1). All assessments will be conducted by a licensed clinician in conjunction with a research assistant.

Mothers (30 in each group) will be recruited through the Women's Program and pediatric practices affiliated with Columbia University Medical Center, including the Columbia Center of the New York Presbyterian Hospital, as well as its satellite center, the Allen Pavilion, and the Children's Hospital of New York. Approximately 90 women will need to screened to recruit 60 women for the study.

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
None

入排标准

年龄范围
3 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Maternal age 18-40 years
  • Child age 3-5 years
  • Maternal Beck Depression Inventory-II score 14-30
  • Maternal report of at least two of ten child emotional/behavioral problems (excessive shyness, fussiness, sleep pattern problems, irritability, frequent inappropriate behavior) during phone screen administration of an adapted version of the Child Behavior Checklist.

排除标准

  • Maternal lack of fluency in English as assessed through phone screening
  • Maternal self-report of suicidality as assessed through Beck Depression Inventory-II
  • Maternal self-report of Psychotic/Bipolar/Thought disorder
  • Maternal self-report of substance abuse problems in the past 6 months
  • Maternal report of child's lack of fluency in English
  • Maternal report of child's developmental disorders / mental retardations / significant speech and language delays

研究组 & 干预措施

Child Parent Psychotherapy (CPP)

Experimental

Following Time 1 (pre-treatment) assessment, mother-child patient dyads will be randomly assigned to either Child Parent Psychotherapy (CPP) treatment or control (usual treatment) group. CPP treatment will be conducted by a CPP study clinician over approximately six months (24 weekly sessions). CPP includes developmental guidance and fostering affect regulation , continuity in daily living, reciprocity between mother and child, and helping the mother and child understand themselves and each other in the context of the maternal psychiatric functioning and/or familial exposure to trauma.

干预措施: Child Parent Psychotherapy (CPP) (Behavioral)

Usual Treatment

Active Comparator

Following Time 1 (pre-treatment) assessment, mother-child patient dyads randomized to the control group will be referred for usual treatment via referral to therapists in the community and at Columbia University Medical Center, for psychoeducation, counseling/ therapy for maternal depressive symptoms, and child behavioral/ emotional difficulties. Additionally, control patient dyads will be monitored through regular contact with the study research assistant. If the research assistant detects worsening of depressive symptoms or the presentation of new symptoms, a licensed study clinician will follow up to assess mother/ child's psychiatric functioning and make necessary referrals to alternative treatments or arrange an emergency evaluation, if needed.

干预措施: Control (usual treatment) (Behavioral)

结局指标

主要结局

Change in Maternal Symptoms of Depression (Beck Depression Inventory)

时间窗: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)

Change in maternal depression (Beck Depression Inventory) will assessed at Time 1 (pre-treatment) assessment, Time 2 (after 12 sessions or an average of three months), Time 3 (after 24 sessions or an average of six months), and Time 4 (six months after 24 treatment sessions or an average of one year after Time 1). Assessments will be conducted by a licensed clinical psychologist in conjunction with a research assistant. Control variables i.e. daily stressors (Daily Hassles and Uplifts Scale), and social support (Social Support Questionnaire) will be assessed each time.

Change in Children's Emotional/Behavioral Functioning (Child Behavior Checklist)

时间窗: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)

Change in children's emotional and behavioral functioning (mother and a co-informant identified by the mother as someone who observes the child frequently will be asked to complete the Child Behavior Checklist) at Time 1 (pre-treatment) assessment, Time 2 (after 12 sessions or an average of three months), Time 3 (after 24 sessions or an average of six months), and Time 4 (six months after 24 treatment sessions or an average of one year after Time 1).

次要结局

  • Change in Maternal Post-Traumatic Stress Symptoms (Post-traumatic Diagnostic Scale)(1 year (six months after 24 session treatment or average of one year after pre-treatment assessment))
  • Change in Child Mood and Post-Traumatic Stress Symptoms(1 year (six months after 24 session treatment or average of one year after pre-treatment assessment))
  • Change in Children's Social Processes (NEuroPSYchological Assessment (NEPSY - II), Affect Recognition and Theory of Mind subtests)(1 year (six months after 24 session treatment or average of one year after pre-treatment assessment))
  • Change in Mothers' Levels of Immune Marker (C-Reactive Protein and Secretory Immunoglobulin A in Saliva)(1 year (six months after 24 session treatment or average of one year after pre-treatment assessment))
  • Change in Maternal Parenting-Related Cognitions (Working Model of the Child Interview and Parenting Sense of Competence Scale)(1 year (six months after 24 session treatment or average of one year after pre-treatment assessment))
  • Change in Mothers' Levels of Basal Cortisol (in Saliva)(1 year (six months after 24 session treatment or average of one year after pre-treatment assessment))
  • Change in Maternal Global Symptoms of Distress (Symptom Checklist-90-R)(1 year (six months after 24 session treatment or average of one year after pre-treatment assessment))
  • Change in Child's Executive Function(1 year (six months after 24 session treatment or average of one year after pre-treatment assessment))
  • Change in Maternal Emotional Availability (free play coding using Emotional Availability scales)(1 year (six months after 24 session treatment or average of one year after pre-treatment assessment))
  • Change in Children's Levels of Basal Cortisol (in Saliva)(1 year (six months after 24 session treatment or average of one year after pre-treatment assessment))
  • Change in Children's Levels of Immune Marker (C-Reactive Protein and Secretory Immunoglobulin A in Saliva)(1 year (six months after 24 session treatment or average of one year after pre-treatment assessment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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