Supporting the Transition to and Engagement in Parenthood

Mental Health Issue Clinical Trial

— STEP  

Official title:

Phase 2 of STEP (Supporting the Transition to and Engagement in Parenthood): A Prenatal Intervention for Women Who Experienced Childhood Trauma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04829864
• Other study ID #: STEP Phase 2
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 15, 2018
• Est. completion date: May 15, 2023

Study information

• Verified date: June 2022
• Source: Université du Québec à Trois-Rivières
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

STEP (Supporting the Transition to and Engagement in Parenthood) is a manualized group intervention for pregnant women exposed to early life adversity designed to foster emotion regulation and reflective capacities in participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: May 15, 2023
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women ages 18+ years

• Interested in reflecting about their experience of pregnancy and willing to attend weekly sessions in group setting.

• Must speak French as their first language

Exclusion Criteria:

• Severe psychiatric disorders (schizophrenia, bipolar disorder)

• Severe emotional dysregulation

• Current self-harm

• Not sure to keep the child

• High level of hostility

Related Conditions & MeSH terms

• Maternal Distress
• Mental Health Issue
• Prenatal Stress
• Psychological Trauma
• Trauma, Psychological
• Wounds and Injuries

Intervention

Behavioral:
• STEP
The program is offered by two facilitators to groups of three to seven women, in-person or online. The program is divided in three phases entitles "Becoming a mother"; "A look at my own history" and "Looking ahead". The first phase aims to explore and normalize the emotions experienced by the participants in the course of their pregnancy and to support the use of healthy emotion regulation strategies. The second phase aims to support mentalization of trauma, by discussing the nature of trauma and its impact; by validating participants' feelings as understandable responses to trauma; by supporting a reflection on positive and harsh experiences with significant others and the ways both types of experiences influenced participants' mental states; and identifying how participants coped with trauma. In the last phase, discussions focus on participants' needs and strengths, on available resources to support resilience and envision positive and challenging moments with the child.

Locations

Country	Name	City	State
Canada	Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale	Québec	Quebec
Canada	Centre intégré de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec	Trois-Rivières	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières	Canada Research Chairs Endowment of the Federal Government of Canada, Public Health Agency of Canada (PHAC), Social Sciences and Humanities Research Council of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Inflammation	Inflammation will be assessed using blood samples at baseline, at the end of the third trimester of pregnancy and around 6 months postpartum. Change between baseline and the end of pregnancy, as well as between baseline and 6 months postpartum will be assessed.	Data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. The assessment time frame thus covers a period of 13 months.
Other	Change in cortisol	Systemic cortisol will be assessed using blood samples at baseline, at the end of the third trimester of pregnancy and around 6 months postpartum. Change between baseline and the end of pregnancy, as well as between baseline and 6 months postpartum will be assessed.	Data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. The assessment time frame thus covers a period of 13 months.
Other	Personality dysfunctions	Personality dysfunctions are assessed at baseline and will be considered as a moderator of the intervention effectiveness. Personality dysfunctions will be measured using the Self and Interpersonal Functioning Rating Scale, a 24-item self-report questionnaire designed to assess the four core elements of personality pathology (Identity, Self-direction, Empathy, and Intimacy) from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Level of Personality Functioning for personality disorders	Administered at one time-point, at the second trimester of pregnancy. The measure will assess current level of personality dysfunctions.
Other	Change in intimate partner violence	Participants are invited to complete a self-report questionnaire of intimate partner violence. Change between baseline and 6 months postpartum will be assessed.	Data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. The assessment time frame thus covers a period of 13 months.
Primary	Change in psychological distress from baseline (2nd trimester of pregnancy) to the end of the third trimester of pregnancy (around 36 weeks) and from baseline to 6-months postpartum	Participants are invited to complete a self-report questionnaire (Kessler Distress Scale) assessing psychological distress. Change between baseline and end of pregnancy will be assessed, as well as between baseline and 6-month postpartum,	Data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. The assessment time frame thus covers a period of 13 months.
Primary	Perception of change in domains of functioning during pregnancy	We developed an instrument assessing one's perception of change (negative change to positive change) across multiple domains of functioning including the quality of the relationship with the partner; the quality of the relationship with significant others, self-esteem; emotion recognition, regulation and expression; social support and parental confidence. These domains will be assessed separately.	Administered at one time-point, at the end of the third trimester of pregnancy. The participant will report on perceived changes during the last 9 months.
Primary	Level of satisfaction concerning the intervention	Participants are invited to complete a self-report questionnaire assessing their level of satisfaction after each session and at the end of the program, using a Likert scale. A semi-structured interview is also administered at the end of the program that will provide qualitative information regarding their appreciation of the program.	Satisfaction assessed after each session of the program and after its ending. Satisfaction is thus assessed between the second trimester of pregnancy and 36-weeks of pregnancy, for a total time frame up to 7-months.
Primary	Prenatal reflective functioning	Participants will complete the Pregnancy Interview at the end of the third trimester of pregnancy. The interview will be subsequently coded for prenatal reflective functioning. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.	Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of reflective functions.
Primary	Parental reflective functioning	Participants will complete the Parental Reflective Functioning Questionnaire at 6 months postpartum. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.	Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
Primary	Change in trauma-specific reflective functioning	The Failure to mentalize trauma questionnaire (FMTQ) will be administered at baseline, at the end of the third trimester of pregnancy and at 6-months postpartum. Change between time-points will be assessed.	Data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. The assessment time frame thus covers a period of 13 months.
Primary	Change in trauma-specific reflective functioning	Participants will participate to the Trauma Meaning Making Interview (TMMI) at 6-months postnatal. The interview will be subsequently coded for trauma-specific reflective functioning. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.	Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
Secondary	Change in post-traumatic stress symptoms from baseline (2nd trimester of pregnancy) to the end of the third trimester of pregnancy (around 36 weeks) and from baseline to 6-months postpartum	Participants are invited to complete a self-report questionnaire of PTSD symptoms (Post-traumatic checklist for DSM-5). Change between baseline and the end of pregnancy will be assessed as well as between baseline and 6-months postpartum	Data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. The assessment time frame thus covers a period of 13 months.
Secondary	Change in anger from baseline (2nd trimester of pregnancy) to the end of the third trimester of pregnancy (around 36 weeks) and from baseline to 6-months postpartum	Participants are invited to complete a self-report questionnaire of anger states (STAXI). Change between baseline and the end of pregnancy will be assessed as well as between baseline and 6-months postpartum	Data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. The assessment time frame thus covers a period of 13 months.
Secondary	Change in perception of parental competence	Participants are invited to complete a self-report questionnaire of maternal confidence (Maternal confidence questionnaire). Change between baseline and the end of pregnancy will be assessed.	Data will be collected at recruitment (2nd trimester of pregnancy) and at 36-weeks of pregnancy. The assessment time frame thus covers a period of 7 months.
Secondary	Change in antenatal attachment	Participants are invited to complete a self-report questionnaire of antenatal attachment (Maternal antenatal attachment scale). Change between baseline and the end of pregnancy will be assessed.	Data will be collected at recruitment (2nd trimester of pregnancy) and at 36-weeks of pregnancy. he assessment time frame thus covers a period of 7 months.
Secondary	Self-compassion	Participants are invited to complete a self-report questionnaire of self-compassion at the end of the third trimester of pregnancy. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.	Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of self-compassion.
Secondary	Connection to care	Participants will be referred to community agencies for resources based on need during their participation to STEP. Their utilization of other resources will be assessed using self-reported questionnaires at the end of the third trimester of pregnancy and at 6 months postpartum	From the third trimester of pregnancy to 6 months postpartum. The assessment time frame thus covers a period of 7 months.
Secondary	Change in emotion regulation strategies	Participants are invited to complete a self-report questionnaire of emotion regulation strategies (CERQ). Change between baseline and the end of pregnancy, as well as between baseline and 6 months postpartum will be assessed.	Data will be collected at recruitment (2nd trimester of pregnancy) and at 36-weeks of pregnancy. he assessment time frame thus covers a period of 7 months.
Secondary	Post-traumatic growth	Participants are invited to complete a self-report questionnaire of post-traumatic growth at the end of the third trimester of pregnancy. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.	Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of post-traumatic growth.
Secondary	Parental stress	Participants are invited to complete a self-report questionnaire of parental stress at 6-months postpartum. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.	Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of parental stress.
Secondary	Maternal bonding	Participants are invited to complete a self-report questionnaire of maternal bonding at 6-months postpartum. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.	Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of maternal bonding.
Secondary	Maternal competence	Participants are invited to complete a self-report questionnaire of maternal sense of competence at 6-months postpartum. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.	Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of perceived maternal competence..
Secondary	Depression	Participants are invited to complete a self-report questionnaire of post-partum depression at the end of the third trimester of pregnancy and at 6-months postpartum. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention separately for each time point.	Data will be collected at 36-weeks of pregnancy and at 6-months postpartum. The assessment time frame thus covers a period of 7 months.
Secondary	Maternal behaviors	Mother-infant interactions will be realized and videotaped for subsequent coding of maternal behaviors around 12-months postpartum. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention	Administered at one time-point, around 12-months postpartum. The measure will assess current maternal behaviors..
Secondary	Change in affective states from baseline (2nd trimester of pregnancy) to the end of the third trimester of pregnancy (around 36 weeks) and from baseline to 6-months postpartum	Participants are invited to complete a self-report questionnaire (Positive and Negative Affect Scale) assessing positive and negative affects. Change between baseline and end of pregnancy will be assessed as well as between baseline and 6-month postpartum,	Data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. The assessment time frame thus covers a period of 13 months.
Secondary	Infant general development	The ASQ-3 will be administered at 6-months postnatal to assess infant development.	Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
Secondary	Infant socio-emotional development	The ASQ-SE will be administered at 6-months postnatal to assess infant socio-emotional development.	Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
Secondary	Infant temperament	The IBQ will be administered at 6-months postnatal to assess infant temperament	Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament

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