Clinical trial NCT02123160: Dyadic Therapy for Mothers and Children
Official title: Dyadic Therapy for Mothers and Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Depression
Behavioral Problems
Keywords: Depression
Dyadic therapy
Behavioral Problems
Child parent therapy
Affect regulation
Immune markers
Cortisol
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Sackler Foundation
First posted: 2014-04-25
Enrollment: 2
Sex: ALL
Minimum age (years): 3
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Psychotherapy-behavioral intervention
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Maternal Symptoms of Depression (Beck Depression Inventory)
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
measure: Change in Children's Emotional/Behavioral Functioning (Child Behavior Checklist)
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
Secondary outcomes:
measure: Change in Children's Social Processes (NEuroPSYchological Assessment (NEPSY - II), Affect Recognition and Theory of Mind subtests)
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
measure: Change in Maternal Parenting-Related Cognitions (Working Model of the Child Interview and Parenting Sense of Competence Scale)
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
measure: Change in Maternal Emotional Availability (free play coding using Emotional Availability scales)
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
measure: Change in Children's Levels of Basal Cortisol (in Saliva)
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
measure: Change in Children's Levels of Immune Marker (C-Reactive Protein and Secretory Immunoglobulin A in Saliva)
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
measure: Change in Mothers' Levels of Basal Cortisol (in Saliva)
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
measure: Change in Mothers' Levels of Immune Marker (C-Reactive Protein and Secretory Immunoglobulin A in Saliva)
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
measure: Change in Maternal Global Symptoms of Distress (Symptom Checklist-90-R)
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
measure: Change in Maternal Post-Traumatic Stress Symptoms (Post-traumatic Diagnostic Scale)
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
measure: Change in Child Mood and Post-Traumatic Stress Symptoms
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
measure: Change in Child's Executive Function
timeFrame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute, Columbia University Medical Center
name: Catherine Monk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York State Psychiatric Institute
name: Andrew Gerber, MD
role: STUDY_DIRECTOR
affiliation: Columbia University
name: Archana Basu, PhD
role: STUDY_DIRECTOR
affiliation: Columbia University
name: Elizabeth Werner, PhD
role: STUDY_DIRECTOR
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