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Copenhagen Infant Mental Health Project: Enhancing Parental Sensitivity and Attachment (CIMHP) (CIMHP)

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ClinicalTrials.gov Identifier: NCT02497677
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : November 23, 2016
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Mette Væver, University of Copenhagen

Brief Summary:
Infant mental health is a significant public health issue as early adversity and expose to childhood stress has life-long consequences for the affected children. Helping families at risk correct their adverse effects on the infant has the potential to halt a negative spiral effect where vulnerable parents fail to cope with an at-risk child - which in turn, adds to the child's vulnerability, negatively affects the parents, and so forth. Over a four year period, an estimated 17.600 dyads will be screened in the City of Copenhagen using standardized screening instruments in detecting infant social withdrawal (ADBB) and maternal postnatal depression (EPDS). A sample of 314 eligible parent(s) will enter into a clinical, randomized control trial to test the efficacy of an 8 week group counseling program, Circle of Security Parenting (COS-P) compared to Care as Usual(CAU) in enhancing maternal sensitivity, child attachment and cognitive development. CIMHP is the first large-scale randomized controlled study to test the efficacy of COS-P in promoting parental sensitivity, child attachment and cognitive development in Denmark. Results will provide evidence regarding the efficacy of an American short term indicated parenting group program when implemented in a Scandinavian country.

Condition or disease Intervention/treatment Phase
Infant Social Withdrawal Maternal Postnatal Depression Behavioral: Circle of Security -Parenting Behavioral: Care as Usual Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Copenhagen Infant Mental Health Project: A Randomized Controlled Trial Comparing Circle of Security-Parenting and Care as Usual as Interventions Targeting Infant Mental Healths Risks
Study Start Date : July 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Circle of Security-Parenting
Circle of Security-Parenting (COS-P) is a brief educative group program for parents
Behavioral: Circle of Security -Parenting
The COS-P manual and video material has been translated to Danish (Tryghedscirklen - Forældreprogrammet, manual, Lier, 2013). Based on standard video material of parent-infant interactions, parents are trained to see and understand infant attachment behavior and especially to learn about infant miscuing attachment signals. In the current study parents will attend 10 sessions of 1.5 hour duration
Other Name: COS-P

Active Comparator: Care as Usual (CAU)
Care as usual (CAU) i.e. the active control condition will be standard practices for infants and families at risk in Copenhagen.
Behavioral: Care as Usual
CAU are different in the three participating districts and vary in content and duration. All three districts offer (a) group interventions for mothers who experience postnatal depressive symptoms and/or (b) extra counselling home-visits by a health nurse. Number and content of extra home-visits vary in accordance with the families' specific needs, and will rarely exceed 12 extra visits per year.
Other Name: CAU




Primary Outcome Measures :
  1. Maternal sensitivity [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]
    Maternal sensitivity is observed during five minutes mother-infant interaction (free play), and will be assessed using Coding Interactive behavior (CIB, Feldman, 1998).


Secondary Outcome Measures :
  1. Infant-mother attachment quality [ Time Frame: Assessed at follow-up (infant is12-16 months) ]
    Infant-mother attachment will be assessed by the Strange Situation Procedure( Ainswotrth, 1978) is one of the most well-established indicators of how well or poorly toddlers are functioning in their primary attachment relationship (to mother) with long-term consequences for children's social and emotional adaptation throughout childhood and adolescence.

  2. Infant Social withdrawal [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]
    Infant Social Withdrawal will be assessed by the Alarm Distress Baby Scale (ADBB, Guedeney & Fermanian, 2001).

  3. Infants socio-emotional development - maternal and partner's report [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]
    A self-report measure administered to both mother and her partner.

  4. Infant cognitive and language development [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]
    A standardized test situation by a psychologist using the Bayley III Screener (Pearson, 2008)

  5. Maternal Depressive Symptoms [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]
    A self-report measure (EPDS, Cox, Holden & Sagovsky, 1987).

  6. Maternal overall psychological distress [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]
    A self-report measure (SCL-92, Danish version Olsen, Moretnsen & bech, 2004)

  7. Maternal depression diagnosis [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]
    Structural Clinical Interview for DSM-5 Disorders, Research version (First, Williams, Karg & Spitzer, 2015)

  8. Maternal Attachment [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]
    A self-report measure (Experince in Close relationships, ECR, Fraley et al, 2000)

  9. Family Functioning, reported by mother and partner [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]
    A self-report measure (The McMaster Family Functioning Device, FAD, Epstein, Baldwin & Bishop, 1983, Danish version, Thaustum et al, 2009)

  10. Parental Reflective Functioning, reported by mother and partner [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]
    self-report measure (The parental reflective Functioning Questionare, PRFQ-1, Luyten et al, 2009)

  11. Parental Stress, reported by mother and partner [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]
    A self-report measure (The Parenting Stress Index, third edition, PSI, Abidin, 1990, Danish version, Hogrefe Forlag)

  12. Number of extra homes visits by the health nurse [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]
    Reported by the health nurse



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Mother lives in one of the participating three districts of Copenhagen
  • Mother is > 18 years old
  • Mother has an infant in the age of 2-12 months born at term (Gestational age (GA) 37-42) or born preterm (GA 30-36).
  • Mother speaks and understands Danish.
  • Mother is screened positive for symptoms of postnatal depression (EPDS >10) and fulfill criteria for diagnosis of depression assessed in a clinical interview (SCID-5/RV) conducted by a psychologist 10-20 days after EPDS screening AND/OR
  • Infant is scored to be socially withdrawn in two ADBB assessments (ADBB >5) conducted within a range of 10-20 days when the infant is 2, 4 or 8 months.
  • If there is a father/partner this person speaks and understands Danish or English.

Exclusion Criteria:

  • Infant autism and/or early retardation
  • Maternal bipolar disorder and/or psychotic disorder, known severe intellectual impairment, suicidal ideation and/or recent suicide attempt and/or present alcohol/substance abuse.
  • Family intends to move away from the Copenhagen area within the period of the intervention.

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): NCT02497677


Contacts
Contact: Mette Væver, PhD +45 35 32 49 06 mette.vaever@psy.ku.dk
Contact: Johanne Smith-Nielsen, PhD +45 35 32 49 44 johanne.smith.nielsen@psy.ku.dk

Locations
Denmark
UCPH Babylab, University of Copenhagen Recruiting
Copenhagen, Denmark, 1353
Contact: Mette S Væver, PhD    +45 35324906    mette.vaever@psy.ku.dk   
Contact: Johanne Smith-Nielsen, PhD    +45 35324906    johanne.smith.nielsen@psy.ku.dk   
Sponsors and Collaborators
University of Copenhagen
University of Aarhus
Investigators
Principal Investigator: Mette Væver, Phd University of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mette Væver, associate professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02497677     History of Changes
Other Study ID Numbers: UCPH 2015-10
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016

Keywords provided by Mette Væver, University of Copenhagen:
parental sensitivity
child attachment

Additional relevant MeSH terms:
Depression, Postpartum
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders