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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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).
- 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.
- 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).
- 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.
- 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)
- Maternal Depressive Symptoms [ Time Frame: Assessed at follow-up (infant is 12-16 months) ]A self-report measure (EPDS, Cox, Holden & Sagovsky, 1987).
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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
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
|Contact: Mette Væver, PhD||+45 35 32 49 firstname.lastname@example.org|
|Contact: Johanne Smith-Nielsen, PhD||+45 35 32 49 email@example.com|
|UCPH Babylab, University of Copenhagen||Recruiting|
|Copenhagen, Denmark, 1353|
|Contact: Mette S Væver, PhD +45 35324906 firstname.lastname@example.org|
|Contact: Johanne Smith-Nielsen, PhD +45 35324906 email@example.com|
|Principal Investigator:||Mette Væver, Phd||University of Copenhagen|