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Effects of a soft baby carrier on fathering

Effects of a soft baby carrier on fathers' hormonal levels, neural processing of infant signals, and parenting behaviour

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66894783
Enrollment
140
Registered
2021-07-22
Start date
2018-03-02
Completion date
Unknown
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensitive and involved parenting in fathers Not Applicable

Interventions

Participants are randomised using a random number generator, odd vs even numbers decided on assignment. This intervention manipulates the amount of physical contact between father and

Sponsors

European Research Council
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Male adults who recently had their first baby 2. The infant is healthy and full-term (i.e., born after 37 weeks of gestation)

Exclusion criteria

Exclusion criteria: 1. Not cohabitating with the biological mother of the child 2. No mastery of the Dutch language 3. A current endocrine disorder, or the use of medication potentially interfering with the endocrine system 4. A cardiovascular disease 5. A psychiatric disorder 6. Current heavy drinking, regular use of soft drugs, use of hard drugs within the past 3 months 7. MRI contraindications (e.g., metallic foreign objects, a neurological disorder) 8. Using a baby carrier for over 5 hours per week at the time of inclusion 9. Having an upper torso injury that could hinder the use of a baby carrier

Design outcomes

Primary

MeasureTime frame
Quality of interaction with infant measured using the Ainsworth (1974) observation scales and Challenging Play Behavior scales at baseline (2 months), after the intervention (3.5 months) and at follow-up (7 months)

Secondary

MeasureTime frame
1. Involvement in infant care measured using a questionnaire and a mobile phone application at baseline (2 months), after the intervention (3.5 months) and at follow-up (7 months) 2. Oxytocin levels and cortisol levels (baseline and reactivity to interaction with infant) measured using saliva and hair samples at baseline (2 months), after the intervention (3.5 months) and at follow-up (7 months) 3. Differential activity and connectivity in parental brain areas, resting state and reactivity to infant stimuli, measured using (f)MRI at baseline (2 months), after the intervention (3.5 months) and at follow-up (7 months)

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026