Copenhagen Infant Mental Health Project: Enhancing Parental Sensitivity and Attachment (CIMHP) (NCT02497677) | Clinical Trial Compass
CompletedNot Applicable
Copenhagen Infant Mental Health Project: Enhancing Parental Sensitivity and Attachment (CIMHP)
Denmark314 participantsStarted 2015-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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* Infant is scored to be socially withdrawn in two ADBB assessments (ADBB \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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maternal sensitivity
Timeframe: Assessed at follow-up (infant is 12-16 months)