Safe Mothers, Safe Children Initiative for PTSD and Depression
This study, called the Safe Mothers, Safe Children Initiative, is looking at two behavioral therapies for mothers experiencing Post-Traumatic Stress Disorder (PTSD) and depression, who also have children aged 1-10 years. The therapies are P-STAIR (which combines Skills Training in Affective and Interpersonal Regulation with Parent-Child Interaction Therapy) and Supportive Counseling (a non-trauma focused therapy). Researchers want to see if P-STAIR is better at treating maternal PTSD and reducing child maltreatment. To join, you must be a mother receiving preventive services, have a PTSD severity score of 28 or higher or probable PTSD, be the legal guardian of a child aged 1-10, and be able to read, write, and speak English or Spanish. The study aims to enroll 160 participants, but its current recruitment status is unclear.
- Study design
- This is a randomized controlled trial where participants are randomly assigned to receive either P-STAIR or Supportive Counseling. Approximately 160 mothers will participate.
- What's involved
- You would receive 23 sessions of either P-STAIR or Supportive Counseling, with assessments before, during, and after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be monitored for six months after completing treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safe Mothers, Safe Children Initiative
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Michael A Lindsey · PRINCIPAL_INVESTIGATOR · New York University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5)Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5) is a 24-item self-report measure of PTSD symptoms over the last month. Items are rated on a 5-point scale of frequency and severity ranging from 0 ("not at all") to 4 ("6 or more times a week/severe"). Higher scores indicate more severe PTSD symptoms. PDS-5 will be used to monitor change in PTSD symptoms over treatment implementation. PDS-5 is also used during the baseline to evaluate for inclusion/exclusion criteria.
- Center for Epidemiological Studies-Depression (CES-D)Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Center for Epidemiological Studies-Depression (CES-D) is a 20-item self-report measure of symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Items are rated on a 3-point scale ranging from 0 ("rarely or none of the time") to 3 ("most or almost all of the time"). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. CES-D will be used to assess change in depression symptoms over treatment implementation.
- Dyadic Parent-Child Interaction Coding System-IV (DPICS)Change from baseline (pre-treatment) to mid-treatment at session 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Dyadic Parent-Child Interaction Coding System-IV (DPICS) examines the quality of parent-child social interaction in three 5-minute situations: child-directed play, parent-directed play, and clean-up. Positive skills include praise, reflect, and describe, and negative skills include questions, commands, and criticisms. Observations are coded by trained DPICS scorers to produce total scores. DPICS scores allow us to track the changes in positive and negative parenting scores over treatment implementation.
- New foster care removalsEvery six-months for 10 years
Data is collected through the New York State Child Welfare Registry (NYSCWR) semi-annually on the number of out-of-home placements for 10 years for completers and non-completers who have consented into the study. Number of new foster care removals are located by unique NYSCWR identifiers collected at time of consent. Out-of-home placement data, in addition to new substantiated welfare reports, will be used to assess recidivism.
- New child abuse/neglect welfare reportsEvery six-months for 10 years
Data is collected through the New York State Child Welfare Registry (NYSCWR) semi-annually on the number of substantiated abuse/neglect reports for 10 years for completers and non-completers who have consented into the study. Number of new substantiated reports are located by unique NYSCWR identifiers collected at time of consent. New substantiated welfare reports, as well as out-of-home placement data, will be used to assess recidivism.
- Family Preservation Services Usual Care (FPSUC) reportsThroughout study completion, an average 43 weeks
Family Preservation Services Usual Care (FPSUC) is extracted from electronic records that agencies use to document services. FPSUC details the number of services accessed in preventative agencies for clients. Data will be used to statistically control for FPSUC.