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DepressionPhase 1NCT02123160

Dyadic Therapy for Mothers and Children

A Phase 1 study testing Child Parent Psychotherapy (CPP) in people with Depression and Behavioral Problems, run by New York State Psychiatric Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 40 years
Conditions the study is for
Depression, Behavioral Problems
What is being tested?
Child Parent Psychotherapy (CPP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Nov 2013to Oct 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • New York State Psychiatric Institute

    New York, New York, 10032

Other trials in United States

About this study

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.

Read the 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.

Being tested
Child Parent Psychotherapy (CPP), Control (usual treatment)
Keywords
Depression, Dyadic therapy, Behavioral Problems, Child parent therapy, Affect regulation, Immune markers, Cortisol
Medical subject headings
Depression, Problem Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Child Parent Psychotherapy (CPP)Behavioural

    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)Behavioural

    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.

Study groups in NCT02123160
Study groupRoleWhat they receive
Child Parent Psychotherapy (CPP)ExperimentalFollowing 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.
Receives: Behavioral: Child Parent Psychotherapy (CPP)
Usual TreatmentActive comparatorFollowing 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.
Receives: Behavioral: Control (usual treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

Secondary outcomes (11)

  1. 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).

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

  2. 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).

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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).

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

  9. 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).

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

  10. 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).

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

  11. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionOct 2014
  4. Study completionOct 2014

Why it stopped: Loss of staff

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Psychotherapy-behavioral intervention
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02123160
Sponsor's protocol ID
#6687
Status last verified
Aug 2017
First submitted
31 Mar 2014
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Carpenter LL, Gawuga CE, Tyrka AR, Lee JK, Anderson GM, Price LH. Association between plasma IL-6 response to acute stress and early-life adversity in healthy adults. Neuropsychopharmacology. 2010 Dec;35(13):2617-23. doi: 10.1038/npp.2010.159. Epub 2010 Sep 29.

    PubMed 20881945

  • Chandra RK. Nutrition and the immune system from birth to old age. Eur J Clin Nutr. 2002 Aug;56 Suppl 3:S73-6. doi: 10.1038/sj.ejcn.1601492.

    PubMed 12142969

  • Chen E, Miller GE, Kobor MS, Cole SW. Maternal warmth buffers the effects of low early-life socioeconomic status on pro-inflammatory signaling in adulthood. Mol Psychiatry. 2011 Jul;16(7):729-37. doi: 10.1038/mp.2010.53. Epub 2010 May 18.

    PubMed 20479762

  • Coe CL, Laudenslager ML. Psychosocial influences on immunity, including effects on immune maturation and senescence. Brain Behav Immun. 2007 Nov;21(8):1000-8. doi: 10.1016/j.bbi.2007.06.015. Epub 2007 Aug 15.

    PubMed 17706917

  • Coe CL, Lubach GR. Critical periods of special health relevance for psychoneuroimmunology. Brain Behav Immun. 2003 Feb;17(1):3-12. doi: 10.1016/s0889-1591(02)00099-5.

    PubMed 12615044

  • Cole SW. Social regulation of leukocyte homeostasis: the role of glucocorticoid sensitivity. Brain Behav Immun. 2008 Oct;22(7):1049-1055. doi: 10.1016/j.bbi.2008.02.006. Epub 2008 Apr 3.

    PubMed 18394861

  • Danese A, Pariante CM, Caspi A, Taylor A, Poulton R. Childhood maltreatment predicts adult inflammation in a life-course study. Proc Natl Acad Sci U S A. 2007 Jan 23;104(4):1319-24. doi: 10.1073/pnas.0610362104. Epub 2007 Jan 17.

    PubMed 17229839

  • de Heredia FP, Gomez-Martinez S, Marcos A. Obesity, inflammation and the immune system. Proc Nutr Soc. 2012 May;71(2):332-8. doi: 10.1017/S0029665112000092. Epub 2012 Mar 20.

    PubMed 22429824

  • DeVries AC, Craft TK, Glasper ER, Neigh GN, Alexander JK. 2006 Curt P. Richter award winner: Social influences on stress responses and health. Psychoneuroendocrinology. 2007 Jul;32(6):587-603. doi: 10.1016/j.psyneuen.2007.04.007. Epub 2007 Jun 21.

    PubMed 17590276

  • Feder A, Alonso A, Tang M, Liriano W, Warner V, Pilowsky D, Barranco E, Wang Y, Verdeli H, Wickramaratne P, Weissman MM. Children of low-income depressed mothers: psychiatric disorders and social adjustment. Depress Anxiety. 2009;26(6):513-20. doi: 10.1002/da.20522.

    PubMed 19016460

  • Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.

    PubMed 16260528

  • Gouin JP, Glaser R, Malarkey WB, Beversdorf D, Kiecolt-Glaser JK. Childhood abuse and inflammatory responses to daily stressors. Ann Behav Med. 2012 Oct;44(2):287-92. doi: 10.1007/s12160-012-9386-1.

    PubMed 22714139

  • Irwin MR. Human psychoneuroimmunology: 20 years of discovery. Brain Behav Immun. 2008 Feb;22(2):129-39. doi: 10.1016/j.bbi.2007.07.013. Epub 2007 Oct 29.

    PubMed 17911004

  • Kurstjens S, Wolke D. Effects of maternal depression on cognitive development of children over the first 7 years of life. J Child Psychol Psychiatry. 2001 Jul;42(5):623-36.

    PubMed 11464967

  • 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. doi: 10.1097/01.chi.0000181047.59702.58.

    PubMed 16292115

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Child Parent Psychotherapy (CPP) in people with Depression and Behavioral Problems, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Loss of staff). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02123160, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.

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