Child MaltreatmentNCT02522741
Safe Mothers, Safe Children Initiative
A study testing Parenting STAIR in people with Child Maltreatment, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of an evidence-based post-traumatic stress disorder (PTSD) intervention adapted to focus on parenting-related impairment for mothers receiving preventive services. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Child Maltreatment
- What is being tested?
- Parenting STAIR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mothers who are receiving preventive services at the time of study enrollment and have histories of trauma, have symptoms of PTSD, without a history of psychotic disorder, or current domestic violence or substance abuse
- Have a child within the 2-9 age range, and are the child's primary caretaker
- Can communicate in English and/or Spanish
Who cannot join
- Women who have a history of psychotic disorder and/or who meet current DSM-IV criteria for abuse of drug or alcohol
- Women who are experiencing domestic violence at the time of the assessment
- Pregnant women are excluded from this pilot study because they are a potentially particularly vulnerable population. However, women who become pregnant while participating in the study will not be excluded
- Women who report suicidal ideation in the past two weeks on the SCID, or have a history of a suicide attempt during the last year as reported during the SCID interview
- Children who meet diagnostic criteria for developmental disorders (e.g., autism and mental retardation), and/or have a history of childhood psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
The purpose of this study is to evaluate the efficacy of an evidence-based post-traumatic stress disorder (PTSD) intervention adapted to focus on parenting-related impairment for mothers receiving preventive services. The study intervention is adapted from Skills Training in Affective and Interpersonal Regulation (STAIR). The investigators expect that the adaption (Parenting STAIR) has the potential to prevent child maltreatment as well as improve maternal and child well-being by reducing the effects of maternal PTSD and depression on parenting.
The investigators plan to recruit mothers with high levels of trauma-related symptoms from preventive service agencies, and invite them to participate in the study. This study is a single group design, and data will be collected pre-treatment, post-treatment, and 12-week follow-up.
- Conditions
- Child Maltreatment
- Being tested
- Parenting STAIR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting STAIRBehavioural
Parenting-STAIR is an adaptation of a 16 session study therapy entitled Skills Training in Affective and Interpersonal Regulation/Modified Prolonged Exposure (STAIR/MPE). It generally is comprised of approximately 23 sessions and includes seven didactic interaction parenting sessions. There are threskill building in areas such as e modules within Parenting STAIR: 1) Module 1 focuses on skill building (awareness of emotional states, management of negative feelings, regulation of emotional intensity, etc.); 2) Module 2 involves the processing of memories of trauma and creating a coherent and meaningful life narrative; 3) Module 3 includes both the mother and child, and focuses on increasing maternal attunement and improving parenting skills.
| Study group | Role | What they receive |
|---|---|---|
| Parenting STAIR | Experimental | Not described Receives: Behavioral: Parenting STAIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Clinician Administered PTSD Scale
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Posttraumatic Stress Diagnostic Scale
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Center for Epidemiological Studies Depression Scale
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
The Structured Clinical Interview for the Diagnostic & Statistical Manual of Mental Disorders (DSM)-IV Axis I Disorders
Measured: At baseline
Woman Abuse Screening Tool
Measured: At baseline
Strengths and Difficulties Questionnaire
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Eyberg Child Behavior Inventory
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Developmental Questionnaire
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Traumatic Events Screening Inventory - Parent Report Revised, Trauma Symptom Checklist for Young
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Secondary outcomes (12)
The Parenting Stress Index-Short Form
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
The Conflict Tactics Scale-Parent-Child
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
The Adult-Adolescent Parenting Inventory-2
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
CAGE Substance Abuse Screening Tool
Measured: At baseline for individuals not meeting criteria for PTSD
Yale University PRIME Screening Test
Measured: At baseline for individuals not meeting criteria for PTSD
Connor-Davidson Resilience Scale
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Interpersonal Support Evaluation List
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Life Orientation Test-Revised
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
State Trait Anger Expression Inventory-2
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Difficulties of Emotional Regulation Scale
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Treatment Services Review
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatme
Working Alliance Inventory Short Form for Clients
Measured: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startNov 2010
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude Chemtob, Principal investigator, NYU MEDICAL CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522741
- Sponsor's protocol ID
- 11-00175
- Status last verified
- Dec 2016
- First submitted
- 7 Aug 2015
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Mothers, Safe Children Initiative
- ClinicalTrials.gov ID
- NCT02522741
- Acronym / sponsor ID
- 11-00175
- Conditions
- Child Maltreatment
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of an evidence-based post-traumatic stress disorder (PTSD) intervention adapted to focus on parenting-related impairment for mothers receiving preventive services. The study intervention is adapted from Skills Training in Affective and Interpersonal Regulation (STAIR). The investigators expect that the adaption (Parenting STAIR) has the potential to prevent child maltreatment as well as improve maternal and child well-being by reducing the effects of maternal PTSD and depression on parenting.
The investigators plan to recruit mothers with high levels of trauma-related symptoms from preventive service agencies, and invite them to participate in the study. This study is a single group design, and data will be collected pre-treatment, post-treatment, and 12-week follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parenting STAIR | Experimental | Behavioral: Parenting STAIR |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mothers who are receiving preventive services at the time of study enrollment and have histories of trauma, have symptoms of PTSD, without a history of psychotic disorder, or current domestic violence or substance abuse
- Have a child within the 2-9 age range, and are the child's primary caretaker
- Can communicate in English and/or Spanish
Key exclusion criteria (5 listed)
- Women who have a history of psychotic disorder and/or who meet current DSM-IV criteria for abuse of drug or alcohol
- Women who are experiencing domestic violence at the time of the assessment
- Pregnant women are excluded from this pilot study because they are a potentially particularly vulnerable population. However, women who become pregnant while participating in the study will not be excluded
- Women who report suicidal ideation in the past two weeks on the SCID, or have a history of a suicide attempt during the last year as reported during the SCID interview
- Children who meet diagnostic criteria for developmental disorders (e.g., autism and mental retardation), and/or have a history of childhood psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenting STAIRParenting-STAIR is an adaptation of a 16 session study therapy entitled Skills Training in Affective and Interpersonal Regulation/Modified Prolonged Exposure (STAIR/MPE). It generally is comprised of approximately 23 sessions and includes seven didactic interaction parenting sessions. There are threskill building in areas such as e modules within Parenting STAIR: 1) Module 1 focuses on skill building (awareness of emotional states, management of negative feelings, regulation of emotional intensity, etc.); 2) Module 2 involves the processing of memories of trauma and creating a coherent and meaningful life narrative; 3) Module 3 includes both the mother and child, and focuses on increasing maternal attunement and improving parenting skills. | Behavioural | Parenting STAIR |
Primary outcome
The Clinician Administered PTSD Scale
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Posttraumatic Stress Diagnostic Scale
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Center for Epidemiological Studies Depression Scale
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
The Structured Clinical Interview for the Diagnostic & Statistical Manual of Mental Disorders (DSM)-IV Axis I Disorders
Time frame: At baseline
Woman Abuse Screening Tool
Time frame: At baseline
Strengths and Difficulties Questionnaire
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Eyberg Child Behavior Inventory
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Developmental Questionnaire
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Traumatic Events Screening Inventory - Parent Report Revised, Trauma Symptom Checklist for Young
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
12 secondary outcomes
The Parenting Stress Index-Short Form
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
The Conflict Tactics Scale-Parent-Child
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
The Adult-Adolescent Parenting Inventory-2
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
CAGE Substance Abuse Screening Tool
Time frame: At baseline for individuals not meeting criteria for PTSD
Yale University PRIME Screening Test
Time frame: At baseline for individuals not meeting criteria for PTSD
Connor-Davidson Resilience Scale
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Interpersonal Support Evaluation List
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Life Orientation Test-Revised
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
State Trait Anger Expression Inventory-2
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Difficulties of Emotional Regulation Scale
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Treatment Services Review
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatme
Working Alliance Inventory Short Form for Clients
Time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Chemtob principal investigator
NYU MEDICAL CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting STAIR in people with Child Maltreatment, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Clinician Administered PTSD Scale (time frame: Change from baseline to end of treatment (approximately 23 sessions over 23 weeks); change to post-treatment (12 weeks after completion of treatment)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2016.