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New treatment option for PTSD
Official title Safe Mothers, Safe Children Initiative
ClinicalTrials.gov ID: NCT04752618
What this study is testing
- What it's testing
- The purpose of this study is to assess the efficacy of the combined interventions, Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT) or P-STAIR, for treating maternal PTSD and reducing maltreatment recidivism.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (mothers):
- Receiving preventive services at the time of the consent session to participate in the study
- Meeting a severity score of 28 or higher OR probable DSM-5 diagnostic criteria for PTSD (PDS-5)
- Having 1-10-year-old child
- Being the legal guardian for the child with physical and legal custody
You likely can't join if
- (mothers):
- Having suicidal ideation present in the past month prior to pre-assessment or reports of a suicide attempt in the past year (SCID-5)
- Meeting a diagnosis of severe substance or alcohol use disorder (≥ 6 symptoms on SCID) AND not in early remission (≥3 months without meeting any...
- Having current or active symptoms of psychosis in the past month
- Having a disability affecting communication, such as deafness
- Having an index child with a developmental condition that impedes cognitive and/or physical functioning, e.g. autism
See the full eligibility criteria
- (mothers):
- Receiving preventive services at the time of the consent session to participate in the study
- Meeting a severity score of 28 or higher OR probable DSM-5 diagnostic criteria for PTSD (PDS-5)
- Having 1-10-year-old child
- Being the legal guardian for the child with physical and legal custody
- Being able to read, write, and speak English or Spanish
- (mothers):
- Having suicidal ideation present in the past month prior to pre-assessment or reports of a suicide attempt in the past year (SCID-5)
- Meeting a diagnosis of severe substance or alcohol use disorder (≥ 6 symptoms on SCID) AND not in early remission (≥3 months without meeting any substance or alcohol use disorder criteria (except craving)
- Having current or active symptoms of psychosis in the past month
- Having a disability affecting communication, such as deafness
- Having an index child with a developmental condition that impedes cognitive and/or physical functioning, e.g. autism
- Having an index child with current symptoms or diagnosis of psychosis as defined by the DSM-5 in the past 3 months
- Experiencing current or history of intimate partner violence (IPV) or family violence: If there is a history of IPV/family violence and the relationship is no longer active, the relationship must have ended for at least...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.