Depression, Parent-Child Relations, PTSD
Conditions
Keywords
PTSD, Depression, STAIR, PC-CARE, Parenting, Parent-Child Relations, Military Family
Brief summary
The goal of this study is to assess Parenting STAIR Modular (PSTAIR-M), a promising and innovative intervention for military-connected mothers (MCM) who have experienced trauma and their young children (ages 2-10). PSTAIR-M aims to help mothers manage the strong feelings that sometimes happen after experiencing something scary or stressful, as well as to better connect with their children and manage their behavior effectively. The main questions the study aims to answer are: from pre-treatment to post-treatment 1) Does PSTAIR-M reduce maternal PTSD and/or depression symptoms?, and 2) Does PSTAIR-M improve parental functioning? Participants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded. Participants may also be invited to participate in an optional, 30-minute online one-on-one qualitative interview, which would be audio and video recorded and would cover participants' experiences with the intervention, the clinic sites, and their providers.
Detailed description
The present study is a single-arm pre-post study conducted in a community mental health setting evaluating Parenting STAIR Modular (PSTAIR-M). This study will enroll N=120 military-connected mothers (MCM) and one index child (aged 2-10) at three Cohen Veterans Network (CVN) clinics (Family Endeavors Clinics in El Paso, Killeen, and San Antonio, TX). Participants will be trauma-exposed MCM who screen positive for PSTD and/or depression and/or demonstrate low parenting self-efficacy, and one identified child (ages 2-10). All enrolled MCM will receive PSTAIR-M, with outcomes assessed at pre- and post-treatment to evaluate change over time. PSTAIR-M will be delivered by CVN clinicians. Parenting STAIR (PSTAIR) combines two existing evidence-based treatments (EBT), Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Care (PC-CARE). PSTAIR-M involves a compact version of PSTAIR in Module 1 and tailored options for Module 2, focusing on skills development (Module 2a), narrative exposure (Module 2b), or parental functioning (Module 2c), implemented based on response to Module 1. Assessments will occur at three timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). Assessments will include self-report instruments and dyadic parenting observations.
Interventions
BEHAVIORALParenting-STAIR Modular (PSTAIR-M)
12-16 PSTAIR-M treatment sessions (approximately 12-16 weeks).
Sponsors
New York University
Cohen Veterans Network
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parenting STAIR Modular (PSTAIR-M) is a 12 to 16-week intervention depending on the Modules selected for each individual participant. All participants receiving PSTAIR-M will receive Module 1. Module 1 is 11 sessions long and consists of four sessions focused on emotional regulation skill development, four focused on narrative exposure, and three involving dyadic parent coaching. Following Module 1, participants will complete the mid-treatment assessment; scores on this assessment will inform a shared decision-making session in which participants and clinicians will determine whether clients can proceed directly to a final termination session or if clients will continue on to Module 2. In Module 2, clients will receive three more sessions focused on skill development (2a), narrative exposure (2b), or parenting (2c).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Military-connected mother, defined as a mother who is either a female service member or veteran or female spouse of a service member or veteran; 2. Has a child aged 2-10; 3. Legal guardian of index child with legal and physical custody; 4. Lifetime trauma exposure (Life Events Checklist (LEC-5); Adverse Childhood Experiences Questionnaire (ACE-Q)); 5. Screen positive for PTSD (defined as a PCL-5 score ≥32 or meeting ≥3 out of 4 DSM-5 symptom criteria \[B, C, D, E\] on the PCL-5), and/or depression (PHQ-9 score ≥8), and/or low parenting self-efficacy (PSOC score \<59); 6. Able to speak and understand English or Spanish; 7. Eligible to receive services at a Steven A. Cohen Military Family Clinic at Endeavors.
Exclusion criteria
1. High risk for suicide (Ask Suicide-Screening Questions (ASQ)); 2. Current psychotic symptoms (DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure Domain VII); 3. Disability affecting communication, such as deafness; 4. Index child with severe developmental disability; 5. Severe substance or alcohol use (The Alcohol, Smoking and Substance Involvement Screening Test - Lite (ASSIST-Lite); Cannabis Use Disorder Identification Test-Short Form (CUDIT-SF)); 6. Currently receiving another trauma-focused individual mental health treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-traumatic stress disorder (PTSD) Checklist 5 | PCL-5 will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). | The PCL-5 will be used to assess severity and change in PTSD symptoms. The PCL-5 is a 20-item self-report measure with strong evidence of reliability and convergent validity. Participants indicate the degree to which they have been bothered by problems related to a traumatic experience in the past month (e.g., "repeated, disturbing dreams of the stressful experience"; "feeling very upset when something reminded you of the stressful experience") on a 5-point Likert scale (0=not at all; 1=a little bit; 2=moderately; 3=quite a bit; 4=extremely). Summed responses yield a continuous score ranging from 0 to 80; higher scores indicate greater symptom severity. |
| Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). | The PHQ-9 will be used to assess severity and change in depressive symptoms. The PHQ-9 is a 9-item self-report measure with strong evidence of reliability and predictive and convergent validity. Participants indicate how often they have been bothered by particular problems within the past two weeks (e.g., "feeling down, depressed, or hopeless"; "poor appetite or overeating") on a 4-point Likert scale (0=not at all; 1=several days; 2=more than half the days; 3=nearly every day). Summed responses yield a continuous score ranging from 0 to 27; higher scores indicate greater symptom severity. |
| Parenting Sense of Competence Scale (PSOC) | PSOC will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). | The PSOC will be used to assess parental functioning as reflected by parenting self-efficacy. The PSOC is a 17-item self-report measure with strong evidence of reliability and validity. Participants indicate how much they agree or disagree with statements related to parenting (e.g., "Being a parent is manageable, and any problems are easily solved"; "My mother/father was better prepared than I am to be a good parent") on a 6-point Likert scale (1=strongly disagree; 2=disagree; 3=somewhat disagree; 4=somewhat agree; 5=agree; 6=strongly agree). Summed responses yield a continuous score ranging from 17 to 102; higher scores indicate greater parenting competency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difficulties in Emotion Regulation Scale (DERS) | DERS will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). | DERS, which measures emotion regulation, will be evaluated as a potential mediator. DERS is a 36-item self-report measure with adequate reliability and construct and predictive validity. Participants indicate how true or untrue various statements about emotions are for them (e.g., "I have no idea how I am feeling"; "I know exactly how I am feeling") on a 5-point Likert scale (1=almost never; 2=sometimes; 3=about half the time; 4=most of the time; 5=almost always). Summed responses yield a continuous score ranging from 36 to 180; higher scores indicate greater emotion regulation difficulty. |
| Brief Cope | Brief Cope will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). | Brief Cope, which measures coping, will be evaluated as a potential mediator. Brief Cope is a 28-item self-report measure with adequate reliability and convergent and discriminant validity. Participants indicate how much or how often they have used various coping strategies (e.g., "I used alcohol or other drugs to make myself feel better"; "I took action to try to make the situation better") on a 4-point Likert scale (0=I didn't do this at all; 1=I did this a little bit; 2=I did this a medium amount; 3=I did this a lot). Summed responses within each of 14 subscales (e.g., substance use; active coping) yields a continuous score ranging from 0 to 6; higher scores indicate greater use of a particular coping strategy. |
| Dyadic Parent-Child Interaction Coding System-IV (DPICS) | DPICS-IV observation will occur at three time points: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). | 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. |
| Treatment Acceptability and Expectations (TAE) | The TAE will be administered at two time points: mid-treatment (after session 11, approximately 11 weeks after baseline) and post-treatment (approximately 17 weeks after baseline). | TAE is a 5-item measure developed by study co-investigator Dr. Marylene Cloitre, will be used to assess acceptability and feasibility of the intervention. Participants are asked to appraise the intervention (e.g., "How logical does this type of treatment seem to you?"; "How successful do you think this treatment will be in reducing your trauma symptoms?") on an 8-point Likert scale (0=not at all; 2=very little; 4=somewhat; 6=moderate; 8=extremely). Summed responses yield a continuous score ranging from 0 to 40; higher scores indicate greater acceptability. |
| Strengths and Difficulties Questionnaire (SDQ) | SDQ will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). | The SDQ will be used to assess child behaviors. The SDQ is a 25-item parent-report measure with good reliability, cross-informant correlation, and retest stability. Participant mothers indicate how true or untrue various statements about child behavior are relative to their participating child (e.g., "Shares readily with other children, for example toys, treats, pencils", "Often fights with other children or bullies them") on a 3-point Likert scale (0=not true; 1=somewhat true; 2=certainly true). Summed responses yield a continuous score ranging from 0 to 40; higher scores indicate greater behavioral difficulty. |
| Military Stress of Life Survey | Military Stress of Life Survey will be administered at two assessment timepoints: pre-treatment (baseline) and post-treatment (approximately 17 weeks after baseline). | The Military Stress of Life Survey, a 14-item self-report measure adapted from the Department of Defense (DoD) Navy and Marine Stress of Life Survey, has been adapted for this study to assess lifetime and recent burden of military-related stressors. Participants indicate (0=no; 1=yes) whether they and their families have ever experienced various stressful situations associated with military life (e.g., "A combat-related injury"; "Difficulty balancing the demands of family life and military duties"), and if so, whether the experience occurred within the last 12 months. For every "yes" response, participants rate how stressful the particular experience was on a 4-point Likert scale (0=not stressful at all; 1=slightly stressful; 2=moderately stressful; 3=very stressful). Summed responses yield a continuous score ranging from 0 to 42; higher scores indicate a greater burden of military-related stressors. |
Countries
United States
Contacts
CONTACTKathrine S Sullivan, PhD
CONTACTGina M Angelotti, MPH
PRINCIPAL_INVESTIGATORKathrine S Sullivan, PhD
New York University
Outcome results
None listed