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Dyadic Therapy for Mothers and Children

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ClinicalTrials.gov Identifier: NCT02123160
Recruitment Status : Terminated (Loss of staff)
First Posted : April 25, 2014
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Sackler Foundation
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral Problems Behavioral: Child Parent Psychotherapy (CPP) Behavioral: Control (usual treatment) Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Psychotherapy-behavioral intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dyadic Therapy for Mothers and Children
Study Start Date : November 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Change in Maternal Symptoms of Depression (Beck Depression Inventory) [ Time Frame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) ]
    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.

  2. Change in Children's Emotional/Behavioral Functioning (Child Behavior Checklist) [ Time Frame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) ]
    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).


Secondary Outcome Measures :
  1. Change in Children's Social Processes (NEuroPSYchological Assessment (NEPSY - II), Affect Recognition and Theory of Mind subtests) [ Time Frame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) ]
    Change in children's social processes (child performance on NEuroPSYchological Assessment (NEPSY - II), Affect Recognition and Theory of Mind subtests) will be 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).

  2. Change in Maternal Parenting-Related Cognitions (Working Model of the Child Interview and Parenting Sense of Competence Scale) [ Time Frame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) ]
    Change in maternal parenting-related cognitions (Parenting Sense of Competence Scale) will be 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), and via the Working Model of the Child Interview (WMCI) at Time 1 (pre-treatment) assessment, and Time 3 (after 24 sessions or an average of six months).

  3. Change in Maternal Emotional Availability (free play coding using Emotional Availability scales) [ Time Frame: 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 will be 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). Mother and children will be asked to play together on a mat on the floor. Toys will be provided. Free play will be videotaped recorded for 15-20 minutes and later coded using the Emotional Availability (EA) scales. Two or more trained coders will code these play sessions.

  4. Change in Children's Levels of Basal Cortisol (in Saliva) [ Time Frame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) ]
    Investigators will collect saliva samples from child (two saliva samples thirty minutes apart at each assessment) 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). Following each saliva collection, the swab will be placed into a salivette tube and frozen at -20°C or -80°C (per manufacturers instructions) until analysis. Once an adequate number of samples have been collected for analysis (to be determined by CRC), analysis will be run for levels of cortisol.

  5. Change in Children's Levels of Immune Marker (C-Reactive Protein and Secretory Immunoglobulin A in Saliva) [ Time Frame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) ]
    At the Time 1 interview on Day 1, and the second interview [Time 2, after 12 sessions or an average of three months], third interview [Time 3, after 24 sessions or an average of six months], and fourth interview [Time 4, six months after the completion of 24 treatment sessions or an average of one year after Time 1], the investigators will collect salivary samples from both mother and child. The investigators will collect two saliva samples from each child, thirty minutes apart during the assessment. Following each saliva collection, the swab will be placed into a salivette tube and frozen at -20°C or -80°C (per manufacturers instructions) until analysis.Once an adequate number of samples have been collected for analysis (to be determined by CRC), analysis will be run for levels of C-Reactive protein and Secretory Immunoglobulin A.

  6. Change in Mothers' Levels of Basal Cortisol (in Saliva) [ Time Frame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) ]
    Investigators will collect saliva samples from mother (two saliva samples thirty minutes apart at each assessment) 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). Following each saliva collection, the swab will be placed into a salivette tube and frozen at -20°C or -80°C (per manufacturers instructions) until analysis. Once an adequate number of samples have been collected for analysis (to be determined by CRC), analysis will be run for levels of cortisol.

  7. Change in Mothers' Levels of Immune Marker (C-Reactive Protein and Secretory Immunoglobulin A in Saliva) [ Time Frame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) ]
    Investigators will collect saliva samples from mother (two saliva samples thirty minutes apart at each assessment) 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). Following each saliva collection, the swab will be placed into a salivette tube and frozen at -20°C or -80°C (per manufacturers instructions) until analysis. Once an adequate number of samples have been collected for analysis (to be determined by CRC), analysis will be run for levels of C-Reactive Protein and Secretory Immunoglobulin A.

  8. Change in Maternal Global Symptoms of Distress (Symptom Checklist-90-R) [ Time Frame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) ]
    Change in maternal global symptoms of distress (Symptom Checklist-90-R) 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).

  9. Change in Maternal Post-Traumatic Stress Symptoms (Post-traumatic Diagnostic Scale) [ Time Frame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) ]
    Change in maternal post-traumatic stress symptoms (Post-traumatic Diagnostic Scale) 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).

  10. Change in Child Mood and Post-Traumatic Stress Symptoms [ Time Frame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) ]
    Change in children's mood and post-traumatic stress symptoms (child performance on Diagnostic Infant and Preschool Assessment (DIPA)) will be 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).

  11. Change in Child's Executive Function [ Time Frame: 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) ]
    Change in children's executive function (child performance on Behavior Rating Inventory of Executive Function will be 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).



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Ages Eligible for Study:   3 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123160


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Sackler Foundation
Investigators
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Principal Investigator: Catherine Monk, PhD New York State Psychiatric Institute, Columbia University Medical Center
Study Director: Andrew Gerber, MD New York State Psychiatric Institute
Study Director: Archana Basu, PhD Columbia University
Study Director: Elizabeth Werner, PhD Columbia University

Publications:

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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02123160     History of Changes
Other Study ID Numbers: #6687
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Keywords provided by New York State Psychiatric Institute:
Depression
Dyadic therapy
Behavioral Problems
Child parent therapy
Affect regulation
Immune markers
Cortisol
Additional relevant MeSH terms:
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Depression
Problem Behavior
Behavioral Symptoms