Recruitment

Recruitment Status
Terminated
Estimated Enrollment
60

Inclusion Criteria

Child age 3-5 years
Maternal Beck Depression Inventory-II score 14-30
Maternal age 18-40 years
...
Child age 3-5 years
Maternal Beck Depression Inventory-II score 14-30
Maternal age 18-40 years
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.

Exclusion Criteria

Maternal report of child's lack of fluency in English
Maternal report of child's developmental disorders / mental retardations / significant speech and language delays
Maternal self-report of suicidality as assessed through Beck Depression Inventory-II
...
Maternal report of child's lack of fluency in English
Maternal report of child's developmental disorders / mental retardations / significant speech and language delays
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 lack of fluency in English as assessed through phone screening

Summary

Conditions
  • Behavioral Problems
  • Depression
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Psychotherapy-behavioral interventionMasking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 3 years and 40 years
Gender
Both males and females

Description

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 represe...

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.

Inclusion Criteria

Child age 3-5 years
Maternal Beck Depression Inventory-II score 14-30
Maternal age 18-40 years
...
Child age 3-5 years
Maternal Beck Depression Inventory-II score 14-30
Maternal age 18-40 years
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.

Exclusion Criteria

Maternal report of child's lack of fluency in English
Maternal report of child's developmental disorders / mental retardations / significant speech and language delays
Maternal self-report of suicidality as assessed through Beck Depression Inventory-II
...
Maternal report of child's lack of fluency in English
Maternal report of child's developmental disorders / mental retardations / significant speech and language delays
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 lack of fluency in English as assessed through phone screening

Tracking Information

NCT #
NCT02123160
Collaborators
Sackler Foundation
Investigators
  • Principal Investigator: Catherine Monk, PhD New York State Psychiatric Institute, Columbia University Medical Center Study Director: Andrew Gerber, MD New York State Psychiatric Institute Study Director: Archana Basu, PhD Columbia University Study Director: Elizabeth Werner, PhD Columbia University
  • Catherine Monk, PhD New York State Psychiatric Institute, Columbia University Medical Center Study Director: Andrew Gerber, MD New York State Psychiatric Institute Study Director: Archana Basu, PhD Columbia University Study Director: Elizabeth Werner, PhD Columbia University