Psychological TraumaNCT04528589
To Repeat or Not to Repeat - Preventing Intergenerational Transfer of Adverse Childhood Experiences
An observational study of Psychological Trauma, run by University Hospital, Akershus at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Psychological Trauma
- What is being tested?
- prenatal psychotherapy
- How many people
- 23 participants
- Where
- 1 siteNorway
- Study dates
- 24 Aug 2020to 12 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Mothers: Clinically referred pregnant women with adverse childhood experiences. Therapists: Therapists providing prenatal psychotherapy to women with adverse childhood experiences
Who may be able to join
- Clinically referred women in gestational week 20-30
- Adverse Childhood Experiences Questionnaire (ACE) score of 2 or more
Who cannot join
- Known IQ below 70
- Ongoing substance abuse
- Planned referral to mother-child center after birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Trauma
- Being tested
- prenatal psychotherapy
- Keywords
- Mother-child relations, parenting, reflective function, child development, psychotherapy
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prenatal psychotherapyOther
Prenatal psychotherapy to break intergenerational risk of adverse childhood events
| Study group | Role | What they receive |
|---|---|---|
| Mothers | Women with adverse childhood experiences referred for treatment in gestational week 20-30 Receives: Other: prenatal psychotherapy | |
| Therapists | Clinicians with experience of providing psychotherapy to women with adverse childhood experiences referred for treatment during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences with prenatal psychotherapy
Qualitative interview conducted 4 months after birth examining the mothers' experiences with the treatment
Measured: 4 months after birth
Secondary outcomes (2)
Maternal Reflective functioning - Parent Development Interview
Assessment of change in mother's reflective functioning, higher score indicates better functioning.
Measured: Gestational week 20-30 to 4 months after birth
Therapists' experiences with providing psychotherapy for women with adverse childhood events
A qualitative interview examining positive and negative experiences with providing prenatal psychotherapy to women to prevent intergenerational transmission of adverse childhood events
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start24 Aug 2020
- Primary completion23 Feb 2023
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Marianne Aalberg, University Hospital, Akershus
- Investigators
- Marianne Aalberg, Phd, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528589
- Sponsor's protocol ID
- 97191
- Status last verified
- Apr 2026
- First submitted
- 16 Jul 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38272852
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04528589
- Acronym / sponsor ID
- 97191
- Conditions
- Psychological Trauma
- Keywords
- Mother-child relations, parenting, reflective function, child development, psychotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothers | – | Other: prenatal psychotherapyWomen with adverse childhood experiences referred for treatment in gestational week 20-30 |
| Therapists | – | –Clinicians with experience of providing psychotherapy to women with adverse childhood experiences referred for treatment during pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mothers: Clinically referred pregnant women with adverse childhood experiences. Therapists: Therapists providing prenatal psychotherapy to women with adverse childhood experiences
Key inclusion criteria (2 listed)
- Clinically referred women in gestational week 20-30
- Adverse Childhood Experiences Questionnaire (ACE) score of 2 or more
Key exclusion criteria (3 listed)
- Known IQ below 70
- Ongoing substance abuse
- Planned referral to mother-child center after birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prenatal psychotherapyPrenatal psychotherapy to break intergenerational risk of adverse childhood events | Other | Mothers |
Primary outcome
Experiences with prenatal psychotherapy
Time frame: 4 months after birth
Qualitative interview conducted 4 months after birth examining the mothers' experiences with the treatment
2 secondary outcomes
Maternal Reflective functioning - Parent Development Interview
Time frame: Gestational week 20-30 to 4 months after birth
Therapists' experiences with providing psychotherapy for women with adverse childhood events
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 38272852Fjeldheim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Aalberg, Phd principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Trauma, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences with prenatal psychotherapy (time frame: 4 months after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04528589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.