To Repeat or Not to Repeat - Preventing Intergenerational Transfer of Adverse Childhood Experiences

April 28, 2026 updated by: Marianne Aalberg, University Hospital, Akershus

To Repeat or Not Repeat - A Mixed Methods Pilot Study of Patients' and Therapists' Experience With Prenatal Psychotherapy to Prevent Intergenerational Transfer of Adverse Childhood Experiences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Even with the best evidence-based treatments, one is often unsuccessful in stopping intergenerational transfer of trauma, abuse, and neglect. The implications for the next generation are severe, affecting physical and emotional health, cognitive development, and relational functioning. The perinatal phase may provide a window of opportunity in efforts to prevent intergenerational transfer of risk factors associated with adverse childhood events. There is a great need for more knowledge about how generational patterns develop and are affected by psychotherapy during pregnancy, infancy and early childhood. Little is known about patients' experiences with prenatal psychotherapy and such knowledge can inform better tailoring of treatment. The present study is the first step of a planned longitudinal study to explore the role of mothers' adverse childhood experiences and child development.

The primary aim of the study is to explore patients' experiences with prenatal psychotherapy provided to pregnant women with adverse childhood experiences and their perspectives of what promotes or hinders change in treatment. Second, aims of the study are to explore a) therapists' experiences with psychotherapy for mothers with adverse childhood experiences, and b) explore the development of intergenerational risk factors. Additionally the investigators will explore the mothers' reflective function during the course of treatment, the role of adverse and benevolent childhood memories, and mother-infant interaction when the infant is four months old. Reflective function seems to be a key factor associated with quality of care in spite of adverse events. Understanding factors associated with possible change in reflective function is thus highly important. Up to 20 clinically referred women in gestational week 20-30 will be recruited. Participants will be assessed at the beginning of therapy and when the child is four months old. A combination of quantitative measures and qualitative interviews will be used. The infant will be assessed with the neonatal assessement scale at age 4-8 weeks and the quality of the mother-infant relationship will be assessed using Parent-Child Relation Assessment at four months. In addition, seven therapists will be interviewed about their experiences providing psychotherapy for this group of high risk patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Norway
      • Jessheim, Norway
        • BUP Øvre Romerike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Mothers
Women with adverse childhood experiences referred for treatment in gestational week 20-30
Other: prenatal psychotherapy
Prenatal psychotherapy to break intergenerational risk of adverse childhood events
Therapists
Clinicians with experience of providing psychotherapy to women with adverse childhood experiences referred for treatment during pregnancy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Experiences with prenatal psychotherapy
Time Frame: 4 months after birth
Qualitative interview conducted 4 months after birth examining the mothers' experiences with the treatment
4 months after birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Therapists' experiences with providing psychotherapy for women with adverse childhood events
Time Frame: Through study completion, an average of 1 year
A qualitative interview examining positive and negative experiences with providing prenatal psychotherapy to women to prevent intergenerational transmission of adverse childhood events
Through study completion, an average of 1 year
Maternal Reflective functioning - Parent Development Interview
Time Frame: Gestational week 20-30 to 4 months after birth
Assessment of change in mother's reflective functioning, higher score indicates better functioning.
Gestational week 20-30 to 4 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Akershus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
South-Eastern Norway Regional Health Authority

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marianne Aalberg, Phd, University Hospital, Akershus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 97191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychological Trauma

Clinical Trials on prenatal psychotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings