Back to resultsSafe Mothers, Safe Children Initiative (SMSC)
Primary Purpose
PTSD, Depression, Child Maltreatment
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
P-STAIR
Supportive Counseling
Sponsored by
About this trial
This is an interventional treatment trial for PTSD
Eligibility Criteria
Inclusion Criteria:
- Receiving preventive services
- Meeting DSM-5 diagnostic criteria for PTSD (CAPS-5) with or without co-occurring depression (SCID-5)
- Having 1-8-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
Exclusion Criteria:
- 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 DSM-5 criteria for current substance or alcohol use symptoms or diagnosis in the past month (SCID-5)
- Having current symptoms or diagnosis of psychosis as defined by the DSM-5 in the past year (SCID-5)
- Having a disability affecting communication, such as deafness
- Having an index child with a developmental condition that impedes functioning, e.g. autism spectrum condition
- Having symptoms of psychosis during childhood in the past three 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If there is a history of IPV/family violence and the relationship is no longer active, the relationship must have ended for at least ninety days with no intention of restarting; If there is a history of IPV/family violence, but the relationship is ongoing, there must not have been an IPV/family violence event for at least one year
Sites / Locations
- McSilver Institute for Poverty Policy and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
P-STAIR
Supportive Counseling
Arm Description
Participants will receive 23 weekly individual treatment sessions. Each session will last one hour. P-STAIR is a combination of STAIR and PCIT. STAIR focuses on reduction of PTSD symptoms through enhancement of emotion regulation skills. PCIT focuses on the reduction of negative parenting skills and the increase of positive parenting skills.
Participants will receive 23 weekly individual treatment sessions. Each session will last one hour. Supportive counseling has been modified to permit non-trauma discussion of parenting problems. Each session is client-directed and clinicians take an unconditionally supportive role.
Outcomes
Primary Outcome Measures
Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5)
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)
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)
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 removals
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 reports
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) reports
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.
Secondary Outcome Measures
Clinician-administered Post-Traumatic Stress Disorder Scale for DSM-5 (CAPS-5)
Clinician-administered Post-Traumatic Stress Disorder Scale for DSM-5 (CAPS-5) is a 30-item structured interview developed by the U.S. Department of Veterans Affairs National Center for PTSD. It yields a categorical measure of diagnosis and a severity score. Severity scores are calculated from 20 DSM-5 PTSD symptoms and range from 0 ("absent") to 80 ("extreme"). It has strong reliability/validity. CAPS-5 will be used to assess change in PTSD diagnosis criteria and severity over treatment implementation.
Structured Clinical Interview for DSM-5 (SCID-5)
Structured Clinical Interview for DSM-5 (SCID-5) is the gold standard for determining DSM-5 Axis I current diagnoses and psychiatric history. The SCID-5 depression, alcohol and substance use, and psychosis modules will be used. SCID-5 will be used to track changes in depression, substance use/abuse, and symptoms of psychosis, as well as to evaluate inclusion/exclusion criteria.
Difficulties in Emotion Regulation Scale (DERS)
Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure used to assesses emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation. DERS has adequate construct and predictive validity and good test-retest reliability. DERS will be used to evaluate level of emotion regulation skills during treatment implementation.
Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1)
Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1) is a self-reporting inventory that measures parental behaviors and is commonly used to assess the risk of child abuse and neglect. Items are rated on a scale of 1 ("strongly agree") to 5 ("strongly disagree"). AAPI-2.1 has five sub-constructs: expectations of children, parental empathy towards children's needs, use of corporal punishment, parent-child family roles, and children's power and independence. Higher scores indicate lower risk of parental abuse/neglect. AAPI will be used to monitor the change in parental behaviors over treatment implementation.
Treatment Services Review (TSR)
Treatment Services Review (TSR) is an interview used to gather information about specific mental health services received outside of the study treatment, lifetime treatment history, and treatment received at the time of the baseline (pre) assessment. It describes treatment type (individual therapy vs. group), provider type (psychologist, psychiatrist, social worker), length (in years) and frequency of treatment (rate of appointments), rate of hospitalizations, and medications prescribed.
Treatment Services Review (TSR)
Treatment Services Review (TSR) is an interview used to gather information about specific mental health services received outside of the study treatment, lifetime treatment history, and treatment received during treatment implementation. It describes treatment type (individual therapy vs. group), provider type (psychologist, psychiatrist, social worker), length (in years) and frequency of treatment (rate of appointments), rate of hospitalizations, and medications prescribed.
Treatment Services Review (TSR)
Treatment Services Review (TSR) is an interview used to gather information about specific mental health services received outside of the study treatment, lifetime treatment history, and treatment received between the end of treatment and the six-month follow-up assessment. It describes treatment type (individual therapy vs. group), provider type (psychologist, psychiatrist, social worker), length (in years) and frequency of treatment (rate of appointments), rate of hospitalizations, and medications prescribed.
Therapy Acceptability and Expectations (TAE)
Therapy Acceptability and Expectations (TAE) is a 5-item scale that evaluates credibility and engagement of study treatment. Items range from 0 ("not at all") to 8 ("extremely"). Higher scores indicate greater acceptability of treatment. TAE is administered throughout treatment in order to assess the clinician-client therapeutic relationship and client engagement with treatment. Necessary changes that arise from the TAE are addressed in future treatment sessions.
Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR)
Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR) is a 24-item parent-report measure for preschool-age children used to assess frequency and type of child exposure to traumatic events. TESI-PRR is used to monitor exposure to traumatic events at the time of the baseline (pre) assessment.
Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR)
Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR) is a 24-item parent-report measure for preschool-age children used to assess frequency and type of child exposure to traumatic events. TESI-PRR is used to monitor exposure to traumatic events during treatment implementation.
Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR)
Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR) is a 24-item parent-report measure for preschool-age children used to assess frequency and type of child exposure to traumatic events. TESI-PRR is used to monitor exposure to traumatic events between the end of treatment and the six-month follow-up assessment.
Strengths and Difficulties Questionnaire (SDQ)
Strengths and Difficulties Questionnaire (SDQ) is a 25-item parent-report behavioral screening questionnaire that comprises five sub-scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Items have the following responses: "not true," "somewhat true," and "certainly true." Higher scores indicate a higher likelihood of emotional and/or behavioral difficulties. SDQ will be used throughout treatment to assess change in behavior of the child participating in the parent-child dyadic play observations.
Children's Behavior Questionnaire - Very Short Form (CBQ-VSF)
Children's Behavior Questionnaire - Very Short Form (CBQ-VSF) is a 36-item parent-report of child temperament. Responses are given on a 7-point scale ranging from 1 ("extremely untrue of my child") to 7 ("extremely true of my child"). The questionnaire has 3 sub-scales: surgency/extraversion, negative affectivity, and effortful control. CBQ-VSF will be used throughout treatment to assess change in temperament of the child participating in the parent-child dyadic play observations.
Eyberg Child Behavior Inventory (ECBI)
Eyberg Child Behavior Inventory (ECBI) is a 36-item parent-report designed to assess conduct issues in children ages 2-16. ECBI asks parents to identify problems through "yes/no" questions. The inventory examines the intensity of problems on a scale from 1 ("never") to 7 ("always"). Higher total problem scores indicate more behaviors are a problem for the parent. Higher total intensity scores indicate higher frequency of behaviors. ECBI will be used throughout treatment to assess change in behavior of the child participating in the parent-child dyadic play observations and rate of parental-identified problems.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04752618
Brief Title
Safe Mothers, Safe Children Initiative
Acronym
SMSC
Official Title
Treating Maternal PTSD to Enhance and Reduce Maltreatment Recidivism: Safe Mothers, Safe Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
This study is a two-arm randomized controlled trial (RCT): P-STAIR (23 sessions) vs. supportive counseling (SC) (23 sessions). Eligible cases are randomized to P-STAIR and SC in a 1:1 ratio. Participants will be mothers receiving family preservation services (FPS), with a child in the age range of 1-8 years old, and PTSD (with/without depression). Symptom progress will be measured at pre-treatment, two in-treatment assessments (9 weeks and 16 weeks), post-treatment, and at a 6-month follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Depression, Child Maltreatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
P-STAIR vs Supportive Counseling
Masking
Outcomes Assessor
Masking Description
Assessors and preventive case planners are blind to treatment arm.
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
P-STAIR
Arm Type
Experimental
Arm Description
Participants will receive 23 weekly individual treatment sessions. Each session will last one hour. P-STAIR is a combination of STAIR and PCIT. STAIR focuses on reduction of PTSD symptoms through enhancement of emotion regulation skills. PCIT focuses on the reduction of negative parenting skills and the increase of positive parenting skills.
Arm Title
Supportive Counseling
Arm Type
Active Comparator
Arm Description
Participants will receive 23 weekly individual treatment sessions. Each session will last one hour. Supportive counseling has been modified to permit non-trauma discussion of parenting problems. Each session is client-directed and clinicians take an unconditionally supportive role.
Intervention Type
Behavioral
Intervention Name(s)
P-STAIR
Intervention Description
PCIT+ STAIR
Intervention Type
Behavioral
Intervention Name(s)
Supportive Counseling
Intervention Description
Non-trauma focused psychotherapy
Primary Outcome Measure Information:
Title
Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5)
Description
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.
Time Frame
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
Title
Center for Epidemiological Studies-Depression (CES-D)
Description
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.
Time Frame
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
Title
Dyadic Parent-Child Interaction Coding System-IV (DPICS)
Description
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.
Time Frame
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
Title
New foster care removals
Description
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.
Time Frame
Every six-months for 10 years
Title
New child abuse/neglect welfare reports
Description
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.
Time Frame
Every six-months for 10 years
Title
Family Preservation Services Usual Care (FPSUC) reports
Description
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.
Time Frame
Throughout study completion, an average 43 weeks
Secondary Outcome Measure Information:
Title
Clinician-administered Post-Traumatic Stress Disorder Scale for DSM-5 (CAPS-5)
Description
Clinician-administered Post-Traumatic Stress Disorder Scale for DSM-5 (CAPS-5) is a 30-item structured interview developed by the U.S. Department of Veterans Affairs National Center for PTSD. It yields a categorical measure of diagnosis and a severity score. Severity scores are calculated from 20 DSM-5 PTSD symptoms and range from 0 ("absent") to 80 ("extreme"). It has strong reliability/validity. CAPS-5 will be used to assess change in PTSD diagnosis criteria and severity over treatment implementation.
Time Frame
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
Title
Structured Clinical Interview for DSM-5 (SCID-5)
Description
Structured Clinical Interview for DSM-5 (SCID-5) is the gold standard for determining DSM-5 Axis I current diagnoses and psychiatric history. The SCID-5 depression, alcohol and substance use, and psychosis modules will be used. SCID-5 will be used to track changes in depression, substance use/abuse, and symptoms of psychosis, as well as to evaluate inclusion/exclusion criteria.
Time Frame
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
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure used to assesses emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation. DERS has adequate construct and predictive validity and good test-retest reliability. DERS will be used to evaluate level of emotion regulation skills during treatment implementation.
Time Frame
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
Title
Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1)
Description
Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1) is a self-reporting inventory that measures parental behaviors and is commonly used to assess the risk of child abuse and neglect. Items are rated on a scale of 1 ("strongly agree") to 5 ("strongly disagree"). AAPI-2.1 has five sub-constructs: expectations of children, parental empathy towards children's needs, use of corporal punishment, parent-child family roles, and children's power and independence. Higher scores indicate lower risk of parental abuse/neglect. AAPI will be used to monitor the change in parental behaviors over treatment implementation.
Time Frame
Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up
Title
Treatment Services Review (TSR)
Description
Treatment Services Review (TSR) is an interview used to gather information about specific mental health services received outside of the study treatment, lifetime treatment history, and treatment received at the time of the baseline (pre) assessment. It describes treatment type (individual therapy vs. group), provider type (psychologist, psychiatrist, social worker), length (in years) and frequency of treatment (rate of appointments), rate of hospitalizations, and medications prescribed.
Time Frame
Baseline (pre-treatment)
Title
Treatment Services Review (TSR)
Description
Treatment Services Review (TSR) is an interview used to gather information about specific mental health services received outside of the study treatment, lifetime treatment history, and treatment received during treatment implementation. It describes treatment type (individual therapy vs. group), provider type (psychologist, psychiatrist, social worker), length (in years) and frequency of treatment (rate of appointments), rate of hospitalizations, and medications prescribed.
Time Frame
End of treatment (an average 43 weeks)
Title
Treatment Services Review (TSR)
Description
Treatment Services Review (TSR) is an interview used to gather information about specific mental health services received outside of the study treatment, lifetime treatment history, and treatment received between the end of treatment and the six-month follow-up assessment. It describes treatment type (individual therapy vs. group), provider type (psychologist, psychiatrist, social worker), length (in years) and frequency of treatment (rate of appointments), rate of hospitalizations, and medications prescribed.
Time Frame
Follow-up after treatment completion (six-months after end of treatment)
Title
Therapy Acceptability and Expectations (TAE)
Description
Therapy Acceptability and Expectations (TAE) is a 5-item scale that evaluates credibility and engagement of study treatment. Items range from 0 ("not at all") to 8 ("extremely"). Higher scores indicate greater acceptability of treatment. TAE is administered throughout treatment in order to assess the clinician-client therapeutic relationship and client engagement with treatment. Necessary changes that arise from the TAE are addressed in future treatment sessions.
Time Frame
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
Title
Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR)
Description
Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR) is a 24-item parent-report measure for preschool-age children used to assess frequency and type of child exposure to traumatic events. TESI-PRR is used to monitor exposure to traumatic events at the time of the baseline (pre) assessment.
Time Frame
Baseline (pre-treatment)
Title
Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR)
Description
Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR) is a 24-item parent-report measure for preschool-age children used to assess frequency and type of child exposure to traumatic events. TESI-PRR is used to monitor exposure to traumatic events during treatment implementation.
Time Frame
End of treatment (an average 43 weeks)
Title
Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR)
Description
Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR) is a 24-item parent-report measure for preschool-age children used to assess frequency and type of child exposure to traumatic events. TESI-PRR is used to monitor exposure to traumatic events between the end of treatment and the six-month follow-up assessment.
Time Frame
Follow-up after treatment completion (six-months after end of treatment)
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
Strengths and Difficulties Questionnaire (SDQ) is a 25-item parent-report behavioral screening questionnaire that comprises five sub-scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Items have the following responses: "not true," "somewhat true," and "certainly true." Higher scores indicate a higher likelihood of emotional and/or behavioral difficulties. SDQ will be used throughout treatment to assess change in behavior of the child participating in the parent-child dyadic play observations.
Time Frame
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
Title
Children's Behavior Questionnaire - Very Short Form (CBQ-VSF)
Description
Children's Behavior Questionnaire - Very Short Form (CBQ-VSF) is a 36-item parent-report of child temperament. Responses are given on a 7-point scale ranging from 1 ("extremely untrue of my child") to 7 ("extremely true of my child"). The questionnaire has 3 sub-scales: surgency/extraversion, negative affectivity, and effortful control. CBQ-VSF will be used throughout treatment to assess change in temperament of the child participating in the parent-child dyadic play observations.
Time Frame
Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up
Title
Eyberg Child Behavior Inventory (ECBI)
Description
Eyberg Child Behavior Inventory (ECBI) is a 36-item parent-report designed to assess conduct issues in children ages 2-16. ECBI asks parents to identify problems through "yes/no" questions. The inventory examines the intensity of problems on a scale from 1 ("never") to 7 ("always"). Higher total problem scores indicate more behaviors are a problem for the parent. Higher total intensity scores indicate higher frequency of behaviors. ECBI will be used throughout treatment to assess change in behavior of the child participating in the parent-child dyadic play observations and rate of parental-identified problems.
Time Frame
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
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Mothers will participate. Child gender is a control variable.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Receiving preventive services
Meeting a severity score of 28 or higher OR probable DSM-5 diagnostic criteria for PTSD (PDS-5)
Having 1-8-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
Exclusion Criteria:
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 primary diagnosis of severe substance abuse disorder (≥ 6 symptoms on SCID)
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 ninety days with no intention of restarting; If there is a history of IPV/family violence, but the relationship is ongoing, there must not have been an IPV/family violence event for at least one year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Illaha Sattar
Phone
6466896935
Email
is971@nyu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Lindsey
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McSilver Institute for Poverty Policy and Research
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael A Lindsey
Phone
212-998-5927
Email
ml4361@nyu.edu
First Name & Middle Initial & Last Name & Degree
Ammu Kowolik
Email
ammu@nyu.edu
First Name & Middle Initial & Last Name & Degree
Michael A Lindsey
First Name & Middle Initial & Last Name & Degree
Kathrine Sullivan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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