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

NCT02497677 | Unknown

• 1 other identifier: UCPH 2015-10
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Social Withdrawal; Maternal Postnatal Depression

Keywords

parental sensitivity; child attachment

Outcome Measures

Primary Outcomes (1)

• Maternal sensitivity

  Maternal sensitivity is observed during five minutes mother-infant interaction (free play), and will be assessed using Coding Interactive behavior (CIB, Feldman, 1998).

  Assessed at follow-up (infant is 12-16 months)

Secondary Outcomes (12)

• Infant-mother attachment quality

  Assessed at follow-up (infant is12-16 months)

• Infant Social withdrawal

  Assessed at follow-up (infant is 12-16 months)

• Infants socio-emotional development - maternal and partner's report

  Assessed at follow-up (infant is 12-16 months)

• Infant cognitive and language development

  Assessed at follow-up (infant is 12-16 months)

• Maternal Depressive Symptoms

  Assessed at follow-up (infant is 12-16 months)

Study Arms (2)

Circle of Security-Parenting

EXPERIMENTAL

Circle of Security-Parenting (COS-P) is a brief educative group program for parents

Behavioral: Circle of Security -Parenting

Care as Usual (CAU)

ACTIVE COMPARATOR

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

Interventions

Circle of Security -Parenting BEHAVIORAL

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

Also known as: COS-P

Circle of Security-Parenting

Care as Usual BEHAVIORAL

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.

Also known as: CAU

Care as Usual (CAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• University of Aarhus: collaborator

Study Sites (1)

UCPH Babylab, University of Copenhagen

Copenhagen, 1353, Denmark

Location

Related Publications (2)

• Smith-Nielsen J, Stove LL, Stuart AC, Jakel J, Egmose I, Rohder K, Wendelboe KI, Vaever MS. Differential effects of the circle of security-parenting programme on infant-mother attachment: The role of infant temperament. Br J Clin Psychol. 2025 Dec 18. doi: 10.1111/bjc.70031. Online ahead of print.

  PMID: 41414735 DERIVED

• Vaever MS, Smith-Nielsen J, Lange T. Copenhagen infant mental health project: study protocol for a randomized controlled trial comparing circle of security -parenting and care as usual as interventions targeting infant mental health risks. BMC Psychol. 2016 Nov 22;4(1):57. doi: 10.1186/s40359-016-0166-8.

  PMID: 27876079 DERIVED

Study Officials

• Mette Væver, Phd

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

DK (1)