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Completed

NCT Number: NCT04528589

To Repeat or Not to Repeat - Preventing 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

BUP Øvre Romerike

Jessheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prenatal psychotherapy

Other

Prenatal psychotherapy to break intergenerational risk of adverse childhood events

Primary outcomes

  1. Experiences with prenatal psychotherapy

    Time frame: 4 months after birth

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

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • South-Eastern Norway Regional Health Authority

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Aug 27, 2020
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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