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

NCT02497677 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Infant Social Withdrawal
  • Maternal Postnatal Depression

Interventions

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

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.

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER
  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Mette Væver, Phd · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2020-07-31
Completion
2024-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02497677 on ClinicalTrials.gov