- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528589
To Repeat or Not to Repeat - Preventing Intergenerational Transfer of Adverse Childhood Experiences
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
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marianne Aalberg, Phd
- Phone Number: +4741123534
- Email: marianne.aalberg@ahus.no
Study Contact Backup
- Name: Heidi Fjeldheim, MA
- Phone Number: +4767960000
- Email: heidi.fjeldheim@ahus.no
Study Locations
-
-
-
Jessheim, Norway
- Recruiting
- BUP Øvre Romerike
-
Contact:
- Hege S Syversen, M.A.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Mothers
Women with adverse childhood experiences referred for treatment in gestational week 20-30
|
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
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marianne Aalberg, Phd, University Hospital, Akershus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 97191
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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