Study Results
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Basic Information
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TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2013-11-30
2014-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Child Parent Psychotherapy (CPP)
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.
Child Parent Psychotherapy (CPP)
Child Parent Psychotherapy (CPP) is a multi-theoretical approach to enhance the caregiver-child relationship in the context of the caregiver's psychiatric history (e.g., depression) and/or caregiver/child exposure to traumatic events. Mother and child's in-session interactions are used to provide developmental guidance, and reinforce reciprocity between parent and child, affect regulation , continuity in daily living, and helping mother and child understand themselves and each other in the context of the maternal psychiatric functioning and/or familial exposure to trauma. When there is a history of trauma exposure for mother and/or child, mother and child create a joint narrative of the trauma, identify and address traumatic triggers, and focus on safety issues.
Usual Treatment
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.
Control (usual treatment)
Following Time 1 (pre-treatment) assessment, mother-child patient dyads randomized to the control group will be referred to usual treatment in the community for psychoeducation, counseling/ therapy for maternal depressive symptoms, and child behavioral/ emotional difficulties. Control patient dyads will be closely monitored through regular contact with the study research assistant and follow up by a licensed study clinician to assess mother/ child's psychiatric functioning and make necessary referrals to alternative treatments or arrange an emergency evaluation, if needed.
Interventions
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Child Parent Psychotherapy (CPP)
Child Parent Psychotherapy (CPP) is a multi-theoretical approach to enhance the caregiver-child relationship in the context of the caregiver's psychiatric history (e.g., depression) and/or caregiver/child exposure to traumatic events. Mother and child's in-session interactions are used to provide developmental guidance, and reinforce reciprocity between parent and child, affect regulation , continuity in daily living, and helping mother and child understand themselves and each other in the context of the maternal psychiatric functioning and/or familial exposure to trauma. When there is a history of trauma exposure for mother and/or child, mother and child create a joint narrative of the trauma, identify and address traumatic triggers, and focus on safety issues.
Control (usual treatment)
Following Time 1 (pre-treatment) assessment, mother-child patient dyads randomized to the control group will be referred to usual treatment in the community for psychoeducation, counseling/ therapy for maternal depressive symptoms, and child behavioral/ emotional difficulties. Control patient dyads will be closely monitored through regular contact with the study research assistant and follow up by a licensed study clinician to assess mother/ child's psychiatric functioning and make necessary referrals to alternative treatments or arrange an emergency evaluation, if needed.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
3 Years
40 Years
ALL
No
Sponsors
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Sackler Foundation
OTHER
New York State Psychiatric Institute
OTHER
Responsible Party
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Principal Investigators
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Catherine Monk, PhD
Role: PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute, Columbia University Medical Center
Andrew Gerber, MD
Role: STUDY_DIRECTOR
New York State Psychiatric Institute
Archana Basu, PhD
Role: STUDY_DIRECTOR
Columbia University
Elizabeth Werner, PhD
Role: STUDY_DIRECTOR
Columbia University
Locations
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New York State Psychiatric Institute
New York, New York, United States
Countries
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References
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Other Identifiers
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#6687
Identifier Type: -
Identifier Source: org_study_id
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