Dyadic Therapy for Mothers and Children

New York State Psychiatric Institute

Status and phase: Terminated; Phase 1

Conditions: Behavioral Problems; Depression

Treatments: Behavioral: Control (usual treatment); Behavioral: Child Parent Psychotherapy (CPP)

Study type: Interventional

Funder types: Other

Identifiers

NCT02123160

#6687

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 3 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Child Parent Psychotherapy (CPP)

Experimental group

Description:

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.

Treatment:

Behavioral: Child Parent Psychotherapy (CPP)

Usual Treatment

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control (usual treatment)