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Depression | Dyadic Therapy for Mothers and Children

Depression research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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. Exclusion Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Depression

Behavioral Problems

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral: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.

Behavioral: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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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.

Usual TreatmentFollowing 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.

Study Status

Terminated

Start Date: November 2013

Completed Date: October 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Change in Maternal Symptoms of Depression (Beck Depression Inventory)

Secondary Outcome: Change in Children's Social Processes (NEuroPSYchological Assessment (NEPSY - II), Affect Recognition and Theory of Mind subtests)

Study sponsors, principal investigator, and references

Principal Investigator: Catherine Monk, PhD

Lead Sponsor: New York State Psychiatric Institute

Collaborator: Sackler Foundation

More information:https://clinicaltrials.gov/show/NCT02123160

Carpenter LL, Gawuga CE, Tyrka AR, Lee JK, Anderson GM, Price LH. Association between plasma IL-6 response to acute stress and early-life adversity in healthy adults. Neuropsychopharmacology. 2010 Dec;35(13):2617-23. doi: 10.1038/npp.2010.159. Epub 2010 Sep 29.

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