Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children

Depression Clinical Trial

Official title:

Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06262178
• Other study ID #: 23-1393
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: New York University
• Contact: Kathrine S Sullivan, PhD
• Phone: 3235526056
• Email: ks5313[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study, which includes a clinical trial, is to adapt and assess the efficacy of Parenting-STAIR (PSTAIR), an intervention which combines existing evidence-based treatments Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Care (PC-Care) to reduce symptoms of Post-traumatic Stress Disorder (PTSD) and improve parenting among military-connected mothers. Participants in the clinical trial will receive PSTAIR or trauma-focused treatment as usual (either prolonged exposure or cognitive processing therapy).

Description:

This study will proceed in three phases. In phase 1, the investigators conduct qualitative interviews and focus groups with key informants including military-connected mothers (MCM) to guide adaptation of PSTAIR in Phase 2. The investigators anticipate the outcome of Phase 2 will be a 10-15 session intervention (PSTAIR-M), involving a compact version of PSTAIR in Module 1 and tailored options for Module 2, focusing on mental health (Module 2a) and parental functioning (Module 2b), implemented based on response to Module 1. Phase 3 is a two-arm randomized controlled trial (RCT): PSTAIR (10-15 sessions) vs. treatment as usual (TAU). Eligible cases are randomized to PSTAIR and TAU in a 1:1 ratio. Participants will be trauma-exposed MCM who screen positive for PSTD with/without comorbid depression and one identified child (ages 2-10). Assessments will occur at 3 timepoints. Pre- and post-treatment will include self-report and clinician-administered instruments and dyadic parenting observations. Midpoint assessment (after session 10 to assess change after PSTAIR Module 1) will include only self-report and dyadic observation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. military connected mother, defined as mothers who are either a female service member or veteran or female spouse of a service member or veteran;

2. with a child aged 2-10 (if more than one child in this age range, the mother will indicate child with most behavioral difficulties);

3. lifetime trauma exposure;

4. screen positive for PTSD defined by scores = 32 on PTSD Checklist-5 (PCL-5) with and without depression (scores = 10 on Patient Health Questionnaire-9 (PHQ-9);

5. able to speak and understand English or Spanish.

6. being the legal guardian for the child with physical and legal custody

Exclusion Criteria:

1. high risk for suicide, defined by VA as having intent, means, and a plan;

2. current psychotic symptoms (SCID);

3. communication disability (e.g., deafness);

4. child with diagnosed severe developmental disability

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)

Related Conditions & MeSH terms

• Depression
• Parent-Child Relations
• PTSD

Intervention

Behavioral:
• Parenting-STAIR
10-15 week Parenting-STAIR
• Treatment as Usual
Will include either Prolonged Exposure or Cognitive Processing Therapy

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
New York University	Cohen Veterans Network, University of California, Davis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-traumatic stress disorder (PTSD) Checklist 5	PCL-5 is a widely used self-report measure of PTSD symptoms. The PCL-5 is a scale which ranges from 0 to 80 where higher scores indicate greater symptom severity.	PCL-5 will be administered at three time points: baseline (pre-treatment), after session 10 (approximately 10 weeks after baseline), and immediately post-treatment.
Primary	Patient Health Questionnaire-9 (PHQ-9)	PHQ-9 is a widely used self-report measure of depression symptoms. The PHQ-9 is a scale which ranges from 0 to 27 where higher scores indicate greater symptom severity.	PHQ-9 will be administered at three time points: baseline (pre-treatment), after session 10 (approximately 10 weeks after baseline), and immediately post-treatment.
Primary	Parenting Sense of Competence Scale (PSOC)	PSOC is brief self-report measure that measures parents' satisfaction and sense of self-efficacy. The measure is a scale which ranges from 17 to 102 with higher scores indicating greater sense of competence.	PSOC will be administered at three time points: baseline (pre-treatment), after session 10 (approximately 10 weeks after baseline), and immediately post-treatment.
Secondary	Clinician Administered PTSD Scale Diagnostic and Statistical Manual (DSM) 5 (CAPS 5) Diagnosis	CAPS 5 is the gold-standard interview to diagnose PTSD. It yields a categorical measure of PTSD diagnosis (yes/no).	CAPS-5 will be administered at two time points: baseline (pre-treatment) and immediately post-treatment.
Secondary	Clinician Administered PTSD Scale Diagnostic and Statistical Manual (DSM) 5 (CAPS 5) Symptom Severity	CAPS 5 is the gold-standard interview to diagnose PTSD. In addition to yielding a categorical measure of PTSD diagnosis (yes/no; described above), it yields a symptom severity score which ranges from 0 to 136 wither higher scores indicating greater severity.	CAPS-5 will be administered at two time points: baseline (pre-treatment) and immediately post-treatment.
Secondary	Structured Clinical Interview for DSM 5 (SCID)	SCID is the gold standard for determining DSM-5 diagnoses and psychiatric history. The SCID depression module will be used to assess depressive disorders. Alcohol and substance use and psychotic symptom modules will be used to assess exclusion criteria. The scale yields a categorical measure of diagnoses (yes/no).	SCID will be administered at two time points: baseline (pre-treatment) and immediately post-treatment.
Secondary	Parenting Stress Index 4-Short Form (PSI4-SF)	PSI4-SF is a brief self-report instrument measuring parental distress. The scale has strong psychometric properties. PSI4-SF is a scale with scores which range from 36 to 180 where higher scores indicate greater stress.	PSI4-SF will be administered at two time points: baseline (pre-treatment) and immediately post-treatment.
Secondary	Difficulties in Emotion Regulation Scale (DERS)	DERS assesses emotion regulation and has adequate construct and predictive validity and good test-retest reliability. DERS is a scale with possible scores ranging from 36 to 180 where higher scores indicate greater difficulty with emotion regulation.	DERS will be administered at three time points: baseline (pre-treatment), after session 10 (approximately 10 weeks after baseline), and immediately post-treatment.
Secondary	Brief Cope	Brief Cope is a widely used self-report measure of coping with satisfactory psychometric properties. This scale includes 28 items which reflect 14 subscales that measure both positive and negative coping. Scores on each subscale range from 2-8 with higher scores reflecting more frequent use of this coping behavior.	DERS will be administered at three time points: baseline (pre-treatment), after session 10 (approximately 10 weeks after baseline), and immediately post-treatment.
Secondary	Dyadic Parent-Child Interaction Coding System-IV (DPICS)	Parent interaction will be videotaped and coded by independent assessors. 10% of recordings will also be coded at UC Davis Parent-Child Interaction Therapy (PCIT) Training Center by expert coders unaware of treatment condition. Positive scores include the number of observed praises, reflections, and behavioral descriptions used during the play session, and negative scores include the number of observed questions, commands, and negative talk. DPICS is administered for 15-minutes in total with three 5-minute sessions focusing on child-directed play (CDI), parent-directed play (PDI), and clean-up.	DPICS-IV observation will occur at three time points: baseline (pre-treatment), after session 10 (approximately 10 weeks after baseline), and immediately post-treatment.
Secondary	Treatment Acceptability and Expectations (TAE)	TAE is a five-item scale developed by Cloitre that evaluates credibility and acceptability of study treatment. Therapy Acceptability and Expectations (TAE) is a 5-item scale that evaluates credibility and engagement of study treatment. Scores range from 0 ("not at all") to 8 ("extremely"). Higher scores indicate greater acceptability of treatment.	TAE will be administered at one time point: immediately post-treatment.
Secondary	Strengths and Difficulties Questionnaire (SDQ)	SDQ is a 25-item parent-report behavioral screening questionnaire that comprises five scales and a total symptom score. Each subscale has a range of possible scores from 0--10. We will use the total score which ranges between 0 and 40.	SDQ will be administered at two time points: baseline (pre-treatment) and immediately post-treatment.
Secondary	Eyberg Child Behavior Inventory (ECBI)	ECBI assesses parent report of conduct problems in children ages 2-16 with strong psychometric properties. ECBI has two subscales: Intensity, which ranges from 36-252 and Problem, which ranges from 0-36. On both subscales, higher scores indicate greater severity.	ECBI will be administered at two time points: baseline (pre-treatment) and immediately post-treatment.