Dyadic Therapy for Mothers and Children

Depression Clinical Trial

Official title:

Dyadic Therapy for Mothers and Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02123160
• Other study ID #: #6687
• Status: Terminated
• Phase: Phase 1
• First received: March 31, 2014
• Last updated: August 21, 2017
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Behavioral Problems
• Depression
• Problem Behavior

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Sackler Foundation

Country where clinical trial is conducted

United States, 

References & Publications (27)

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Lieberman AF, Ghosh Ippen C, VAN Horn P. Child-parent psychotherapy: 6-month follow-up of a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2006 Aug;45(8):913-8. — View Citation

Lieberman AF, Van Horn P, Ippen CG. Toward evidence-based treatment: child-parent psychotherapy with preschoolers exposed to marital violence. J Am Acad Child Adolesc Psychiatry. 2005 Dec;44(12):1241-8. — View Citation

McDade TW. Early environments and the ecology of inflammation. Proc Natl Acad Sci U S A. 2012 Oct 16;109 Suppl 2:17281-8. doi: 10.1073/pnas.1202244109. Epub 2012 Oct 8. Review. — View Citation

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Pace TW, Wingenfeld K, Schmidt I, Meinlschmidt G, Hellhammer DH, Heim CM. Increased peripheral NF-?B pathway activity in women with childhood abuse-related posttraumatic stress disorder. Brain Behav Immun. 2012 Jan;26(1):13-7. doi: 10.1016/j.bbi.2011.07.232. Epub 2011 Jul 27. — View Citation

Schechter DS, Coates SW, Kaminer T, Coots T, Zeanah CH Jr, Davies M, Schonfeld IS, Marshall RD, Liebowitz MR, Trabka KA, McCaw JE, Myers MM. Distorted maternal mental representations and atypical behavior in a clinical sample of violence-exposed mothers and their toddlers. J Trauma Dissociation. 2008;9(2):123-47. doi: 10.1080/15299730802045666. — View Citation

Schechter DS, Coots T, Zeanah CH, Davies M, Coates SW, Trabka KA, Marshall RD, Liebowitz MR, Myers MM. Maternal mental representations of the child in an inner-city clinical sample: violence-related posttraumatic stress and reflective functioning. Attach Hum Dev. 2005 Sep;7(3):313-31. — View Citation

Scheeringa MS, Haslett N. The reliability and criterion validity of the Diagnostic Infant and Preschool Assessment: a new diagnostic instrument for young children. Child Psychiatry Hum Dev. 2010 Jun;41(3):299-312. doi: 10.1007/s10578-009-0169-2. — View Citation

Shanahan L, Copeland WE, Worthman CM, Angold A, Costello EJ. Children with both asthma and depression are at risk for heightened inflammation. J Pediatr. 2013 Nov;163(5):1443-7. doi: 10.1016/j.jpeds.2013.06.046. Epub 2013 Aug 3. — View Citation

Shonkoff JP. From neurons to neighborhoods: old and new challenges for developmental and behavioral pediatrics. J Dev Behav Pediatr. 2003 Feb;24(1):70-6. Review. — View Citation

Sohr-Preston SL, Scaramella LV. Implications of timing of maternal depressive symptoms for early cognitive and language development. Clin Child Fam Psychol Rev. 2006 Mar;9(1):65-83. Review. — View Citation

Toth SL, Rogosch FA, Manly JT, Cicchetti D. The efficacy of toddler-parent psychotherapy to reorganize attachment in the young offspring of mothers with major depressive disorder: a randomized preventive trial. J Consult Clin Psychol. 2006 Dec;74(6):1006-16. — View Citation

Weissman MM, Pilowsky DJ, Wickramaratne PJ, Talati A, Wisniewski SR, Fava M, Hughes CW, Garber J, Malloy E, King CA, Cerda G, Sood AB, Alpert JE, Trivedi MH, Rush AJ; STAR*D-Child Team. Remissions in maternal depression and child psychopathology: a STAR*D-child report. JAMA. 2006 Mar 22;295(12):1389-98. Erratum in: JAMA. 2006 Sep 13;296(10):1234. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

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)