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Parenting program tested to boost infant mental health

NCT ID NCT02497677

Knowledge-focused Sponsor: University of Copenhagen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an 8-week parenting program called Circle of Security-Parenting for mothers with depression and infants showing signs of social withdrawal. Researchers compared it to standard care to see if it improves how mothers interact with their babies and helps the child's emotional development. The trial involved 314 mother-infant pairs in Copenhagen.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 314 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jul 2015

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

postpartum depression

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infant social withdrawal Maternal postnatal depression

Contacts and locations

Locations

  • UCPH Babylab, University of Copenhagen

    Copenhagen, 1353, Denmark