NCT04528589

Brief Summary

The main aim of the study is to examine patients' and therapists' experiences with prenatal psychotherapy provided to pregnant women with adverse childhood experiences and how this may influence intergenerational transmission of risk. The investigators will explore a) participants' perspectives on what promoted or prevented change in psychotherapy, b) how the mothers' reflective function changes and possible factors associated with change in reflective function. Up to 20 clinically referred women in gestational week 20-30 will be included and assessed with qualitative interviews and questionnaires at the beginning of treatment and when the baby is 4 months old. The quality of the mother-infant relationship will be assessed. Seven therapists will be interviewed with a qualitative interview schedule. Outcomes of the study will inform individual tailoring of psychotherapy for a high risk group of patients and provide increased knowledge about how intergenerational risk factors change during treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2024

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

July 16, 2020

Last Update Submit

April 28, 2026

Conditions

Keywords

Mother-child relationsparentingreflective functionchild developmentpsychotherapy

Outcome Measures

Primary Outcomes (1)

  • Experiences with prenatal psychotherapy

    Qualitative interview conducted 4 months after birth examining the mothers' experiences with the treatment

    4 months after birth

Secondary Outcomes (2)

  • Maternal Reflective functioning - Parent Development Interview

    Gestational week 20-30 to 4 months after birth

  • Therapists' experiences with providing psychotherapy for women with adverse childhood events

    Through study completion, an average of 1 year

Study Arms (2)

Mothers

Women with adverse childhood experiences referred for treatment in gestational week 20-30

Other: prenatal psychotherapy

Therapists

Clinicians with experience of providing psychotherapy to women with adverse childhood experiences referred for treatment during pregnancy

Interventions

Prenatal psychotherapy to break intergenerational risk of adverse childhood events

Mothers

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mothers: Clinically referred pregnant women with adverse childhood experiences. Therapists: Therapists providing prenatal psychotherapy to women with adverse childhood experiences

You may qualify if:

  • Clinically referred women in gestational week 20-30
  • Adverse Childhood Experiences Questionnaire (ACE) score of 2 or more

You may not qualify if:

  • Known IQ below 70
  • Ongoing substance abuse
  • Planned referral to mother-child center after birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BUP Øvre Romerike

Jessheim, Norway

Location

Related Publications (1)

  • Fjeldheim H, Werner A, Anke T, Moe V, Norheim HS, Aalberg M. Parenting the parent without losing sight of the child. A qualitative study of therapists' experiences with intergenerational adversities in perinatal psychotherapy. Infant Ment Health J. 2024 Mar;45(2):201-216. doi: 10.1002/imhj.22100. Epub 2024 Jan 25.

MeSH Terms

Conditions

Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Marianne Aalberg, Phd

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

July 16, 2020

First Posted

August 27, 2020

Study Start

August 24, 2020

Primary Completion

February 23, 2023

Study Completion

February 12, 2024

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations