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

Psychological Trauma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04528589
• Other study ID #: 97191
• Status: Recruiting
• Start date: August 24, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: August 2020
• Source: University Hospital, Akershus
• Contact: Marianne Aalberg, Phd
• Phone: +4741123534
• Email: marianne.aalberg[@]ahus.no
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychological Trauma

Intervention

Other:
• prenatal psychotherapy
Prenatal psychotherapy to break intergenerational risk of adverse childhood events

Locations

Country	Name	City	State
Norway	BUP Øvre Romerike	Jessheim

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Akershus	South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experiences with prenatal psychotherapy	Qualitative interview conducted 4 months after birth examining the mothers' experiences with the treatment	4 months after birth
Secondary	Maternal Reflective functioning - Parent Development Interview	Assessment of change in mother's reflective functioning	Gestational week 20-30 to 4 months after birth
Secondary	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	Through study completion, an average of 1 year