Dyadic Therapy for Mothers and Children

NCT02123160 | Terminated Phase 1 DMC

• 1 other identifier: #6687
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Behavioral Problems

Keywords

Depression; Dyadic therapy; Behavioral Problems; Child parent therapy; Affect regulation; Immune markers; Cortisol

Outcome Measures

Primary Outcomes (2)

• Change in Maternal Symptoms of Depression (Beck Depression Inventory)

  Change in maternal depression (Beck Depression Inventory) will assessed at Time 1 (pre-treatment) assessment, 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). Assessments will be conducted by a licensed clinical psychologist in conjunction with a research assistant. Control variables i.e. daily stressors (Daily Hassles and Uplifts Scale), and social support (Social Support Questionnaire) will be assessed each time.

  1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)

• Change in Children's Emotional/Behavioral Functioning (Child Behavior Checklist)

  Change in children's emotional and behavioral functioning (mother and a co-informant identified by the mother as someone who observes the child frequently will be asked to complete the Child Behavior Checklist) at Time 1 (pre-treatment) assessment, 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).

  1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)

Secondary Outcomes (11)

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

  1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)

• Change in Maternal Parenting-Related Cognitions (Working Model of the Child Interview and Parenting Sense of Competence Scale)

  1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)

• Change in Maternal Emotional Availability (free play coding using Emotional Availability scales)

  1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)

• Change in Children's Levels of Basal Cortisol (in Saliva)

  1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)

• Change in Children's Levels of Immune Marker (C-Reactive Protein and Secretory Immunoglobulin A in Saliva)

  1 year (six months after 24 session treatment or average of one year after pre-treatment assessment)

Study Arms (2)

Child Parent Psychotherapy (CPP)

EXPERIMENTAL

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.

Behavioral: Child Parent Psychotherapy (CPP)

Usual Treatment

ACTIVE COMPARATOR

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.

Behavioral: Control (usual treatment)

Interventions

Child Parent Psychotherapy (CPP) BEHAVIORAL

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.

Child Parent Psychotherapy (CPP)

Control (usual treatment) BEHAVIORAL

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.

Usual Treatment

Eligibility Criteria

• Age: 3 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Sackler Foundation: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

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MeSH Terms

Conditions

Depression; Problem Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Catherine Monk, PhD

  New York State Psychiatric Institute, Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

• Andrew Gerber, MD

  New York State Psychiatric Institute

  STUDY DIRECTOR

• Archana Basu, PhD

  Columbia University

  STUDY DIRECTOR

• Elizabeth Werner, PhD

  Columbia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Psychotherapy-behavioral intervention

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 25, 2014
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

US (1)