Depression Clinical Trial
Official title:
Dyadic Therapy for Mothers and Children
Verified date | August 2017 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | Sackler Foundation |
United States,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | Change in Children's Social Processes (NEuroPSYchological Assessment (NEPSY - II), Affect Recognition and Theory of Mind subtests) | 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). | 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) | |
Secondary | Change in Maternal Parenting-Related Cognitions (Working Model of the Child Interview and Parenting Sense of Competence Scale) | 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). | 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) | |
Secondary | Change in Maternal Emotional Availability (free play coding using Emotional Availability scales) | 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. | 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) | |
Secondary | Change in Children's Levels of Basal Cortisol (in Saliva) | 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. | 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) | |
Secondary | Change in Children's Levels of Immune Marker (C-Reactive Protein and Secretory Immunoglobulin A in Saliva) | 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. | 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) | |
Secondary | Change in Mothers' Levels of Basal Cortisol (in Saliva) | 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. | 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) | |
Secondary | Change in Mothers' Levels of Immune Marker (C-Reactive Protein and Secretory Immunoglobulin A in Saliva) | 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. | 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) | |
Secondary | Change in Maternal Global Symptoms of Distress (Symptom Checklist-90-R) | 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). | 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) | |
Secondary | Change in Maternal Post-Traumatic Stress Symptoms (Post-traumatic Diagnostic Scale) | 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). | 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) | |
Secondary | Change in Child Mood and Post-Traumatic Stress Symptoms | 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). | 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) | |
Secondary | Change in Child's Executive Function | 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). | 1 year (six months after 24 session treatment or average of one year after pre-treatment assessment) |
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