Effects of a soft baby carrier on fathering

Not Applicable

Completed

• Conditions: Sensitive and involved parenting in fathers; Not Applicable

• Registration Number: ISRCTN66894783
• Lead Sponsor: European Research Council

Brief Summary

2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33146413/ Pretest results (added 05/08/2021) 2021 Results article in https://doi.org/10.1016/j.psyneuen.2021.105380 (added 12/10/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-09-01
• Study Start: 2021-07-22
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 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)<br> 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)<br> 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)<br>