About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

P-STAIR
Behavioral
PCIT+ STAIR
Supportive Counseling
Behavioral
Non-trauma focused psychotherapy

Treatment groups

160 Participants

are divided into 2 treatment groups

Group A: P-STAIRExperimental treatment 1 intervention

Group B: Supportive CounselingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

2

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.

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

3

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.

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

4

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.

Time frame

Every six-months for 10 years

Secondary outcomes

1

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 alcohol and substance use and psychosis modules will be used. SCID-5 will be used to track changes in 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

2

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.

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

3

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.

Time frame

Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up

4

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 and treatment received one year prior to 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)

Safe Mothers, Safe Children Initiative

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts