Telephone Peer Support to Prevent Depression Among Fathers

NCT05250258 | Unknown

• 1 other identifier: 12016/217 -32
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of the pilot study is to investigate whether telephone support from fathers to fathers reduces depressive symptoms and stress among new fathers in Sweden. Forty expectant fathers with the Edinburgh Postnatal Depression Scale (EPDS)\> 10 two weeks after the birth of the child are divided into two groups where half are allocated to telephone support by other fathers (intervention) as a complement to existing parental support, other group get traditionally existing parental support (control). The fathers in the intervention group were allocated telephone-based support from volunteers who have father experience, not mental illness and have undergone training through this project. These volunteers will be trained and supported by trained mentors. Four months after the child is born, data is collected with questionnaires. The intervention group will be compared with the control group and the results from the pilot study form the basis for the forthcoming RCT. Karolinska Institutet's ethics committee has approved the study. Clinical relevance: The long-term goal of this project is to improve the methods for reducing mental illness among fathers, which leads to a positive development for their children and can be used in the development of clinical guidelines to identify and reduce fathers' stress and depressive symptoms.

Conditions

Fathers; Depression

Keywords

Telephone peer support; Depression; Fathers

Outcome Measures

Primary Outcomes (1)

• Changes of Postpartum Depressive symptoms

  Changes in Postpartum Depressive symptoms (PPD), assesed by measured by EPDS (Edinburg postpartumdepression scale) more than 10 score on EPDS= indicate depressive symptoms for fathers, minimum=0 maximum=30 Postpartum Depressive symptoms (PPD), as measured by EPDS (Edinburg postnatal depression scale (Cox et al 1994)

  Baseline and follow up 3 months and one year after the invention

Secondary Outcomes (1)

• Changes of Anxiety symptoms

  Baseline and follow up 3 months and one year after the invention

Other Outcomes (1)

• Satisfaction with telephone peer support

  follow up 3 months after the intervention

Study Arms (2)

telephone peer support

Telephone peer support from experinenced father to father

Other: Telephone peer support by telephone

Routine care

Standard care as usual in child health care, one visit for fathers and nothing added

Interventions

Telephone peer support by telephone OTHER

Peer support by telephone from experienced father to new father with depressive symtoms. 4 times or more if requested during 4 months

telephone peer support

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Participant inclusion criteria on self-reported gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Fathers vid depressive symtoms according to EPDS more than 10 points on the scale.

You may qualify if:

• Aged 18 - 49 years old,
• Less than two weeks postpartum
• Scored more than ten on the -Edingburg postnatal depression scale (EPDS ) scale \<10 = indicate depression
• Swedish or English speaking

You may not qualify if:

• \- Current use of anti-depressant or anti-psychotic medication

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Eva andersson

Huddinge, Stockholm County, 14140, Sweden

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ewa Andersson, Dr

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ewa Andersson, Dr

CONTACT

0736544355; ewa.andersson@ki.se

michael Wells, Dr

CONTACT

0707111051; michael.wells@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: adjunct professor

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: February 22, 2022
• Study Start: January 10, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 10, 2026
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)