NCT03938350.

Study name	Public title: Dialectical behavior therapy for pregnant women Scientific title: Dialectical behavior therapy skills training for high‐risk African American pregnant women: feasibility and acceptability of implementation in prenatal clinics
Methods	Individual RCT (parallel groups; 2 arms)
Participants	Target sample size: 60 participants Age: 18 years and over Sex: female participants Inclusion criteria Self‐identify as African American/Black (includes African American/Black and another race) Able to read, speak and understand English ACE score ≥ 4 from the Expanded ACE Questionnaire PHQ‐9 score ≥ 9 or PC‐PTSD‐5 ≥ 3 Within first or second trimester at time of recruitment Willing and able to participate in research assessments Willing and able to participate in an 8‐week DBT skills training group for mothers‐to‐be group Willing and able to provide informed consent Exclusion criteria Presence of intellectual disability or actively displaying psychotic symptoms
Interventions	Intervention: DBT skills training. Participants in this group will receive 8 weeks of DBT skills training Comparison: treatment as usual. Participants in this study arm will receive treatment as usual consisting of routine prenatal care with any mental health assessment, social work involvement or mental health service provision based on clinician referral or self‐referral
Outcomes	Assessment time point(s) Baseline Post‐intervention Primary outcomes Recruitment rate (feasibility) Score range: not applicable Direction of effect: not applicable Retention rate (feasibility) Score range: not applicable Direction of effect: not applicable Secondary outcomes Acceptability of the Intervention (qualitative participant feedback) Score range: not applicable Direction of effect: not applicable Depression symptom severity (PHQ‐9) Score range: 0 to 27 Direction of effect: higher scores = worse/more harm PTSD symptom severity (PTSD Checklist) Score range: 0 to 80 Direction of effect: higher scores = worse/more harm Emotion dysregulation (Difficulties in Emotion Regulation Scale) Score range: 0 to 180 Direction of effect: higher scores = worse/more harm Mentalising or reflective functioning (The Reflective Functioning Questionnaire) Score range: 0 to 56 Direction of effect: higher scores = worse/more harm
Starting date	16 October 2019
Contact information	Rebecca Hinrichs (rebecca.hinrichs@emory.edu) Abigail Lott (abigail.lott@emoryhealthcare.org)
Notes	Status: completed, no results published Location: USA Funding source: not reported Conflicts of interest: the authors did not report if there were any conflicts of interest