Combined Therapies for Maternal PTSD

(SMSC Trial)

Overseen By Hanaan Osman

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Suicidal ideation, Severe substance use, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 23 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new therapy called P-STAIR (Skills Training in Affective and Interpersonal Regulation combined with Parent-Child Interaction Therapy). It combines techniques to assist mothers with PTSD (a condition caused by experiencing or witnessing a traumatic event) and improve parenting skills. The goal is to determine if this approach can reduce PTSD symptoms and lower the risk of child maltreatment recurrence. The trial compares P-STAIR to supportive counseling, which addresses non-trauma-related parenting issues. Mothers with PTSD who have a child aged 1 to 8 and are the child's legal guardian may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance support for mothers and children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that P-STAIR, a treatment for mothers with PTSD, is likely safe. In a small initial study with mothers involved in child welfare, P-STAIR greatly reduced PTSD symptoms and improved parenting skills, with no major safety issues reported. A review of seven studies on STAIR therapy, a component of P-STAIR, also found significant symptom improvements without serious side effects. Overall, these studies suggest that P-STAIR is well-tolerated and safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional therapies for maternal PTSD, which often include medications or talk therapy, P-STAIR combines two innovative approaches: STAIR and PCIT. STAIR helps reduce PTSD symptoms by enhancing emotion regulation skills, while PCIT focuses on improving parenting by reducing negative and increasing positive parenting skills. This dual approach not only addresses PTSD symptoms but also aims to improve parenting, which can be especially beneficial for mothers. Researchers are excited about P-STAIR because it offers a more comprehensive treatment that targets both emotional and parental challenges associated with maternal PTSD.

What evidence suggests that this trial's treatments could be effective for maternal PTSD?

Research has shown that P-STAIR, which combines Skills Training in Affective and Interpersonal Regulation (STAIR) with Parent-Child Interaction Therapy (PCIT), holds promise for treating PTSD in mothers. In this trial, participants in the P-STAIR arm will receive this combined therapy. A small initial study found that mothers involved in child welfare who received P-STAIR experienced significant reductions in PTSD symptoms and improved parenting skills. The therapy also helped prevent child maltreatment. Another study on STAIR therapy alone found it greatly reduced PTSD symptoms. Overall, early findings suggest that P-STAIR can effectively help mothers manage PTSD and improve their relationships with their children. ^{1 2 3 5 6}

Who Is on the Research Team?

Michael A Lindsey

Principal Investigator

New York University

Are You a Good Fit for This Trial?

This trial is for mothers with PTSD, possibly also depression, who can communicate in English or Spanish and have a child aged 1-8. They must be receiving preventive services, have custody of their child, and meet specific criteria for PTSD severity. Those with recent suicidal thoughts or attempts, psychosis symptoms or diagnosis, substance abuse issues, communication disabilities like deafness, children with developmental conditions impeding function (e.g., autism), or current/recent intimate partner violence are excluded.

Inclusion Criteria

I have a child between 1 and 8 years old.

Being the legal guardian for the child with physical and legal custody

I am currently receiving preventive health services.

Exclusion Criteria

Your child has been diagnosed with or has shown symptoms of psychosis in the past three months.

I have a disability that affects my ability to communicate.

I have been diagnosed with or shown symptoms of psychosis in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 23 weekly individual treatment sessions of P-STAIR or supportive counseling

23 weeks

23 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person)

Long-term follow-up

Data on new foster care removals and child abuse/neglect welfare reports collected semi-annually for 10 years

10 years

What Are the Treatments Tested in This Trial?

Interventions

• P-STAIR
• Supportive Counseling

Trial Overview The 'Safe Mothers, Safe Children Initiative' tests the effectiveness of P-STAIR—a combination of Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT)—in treating maternal PTSD and preventing child maltreatment recurrence.

How Is the Trial Designed?

Group I: P-STAIR Experimental Treatment 1 Intervention

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.

Group II: Supportive Counseling Active Control 1 Intervention

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.

P-STAIR is already approved in United States for the following indications:

Approved in United States as P-STAIR for:

• Maternal PTSD
• Maltreatment recidivism prevention

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Published Research Related to This Trial

Child-parent psychotherapy (CPP) significantly reduced posttraumatic stress symptoms (PTSS) in both parents and children, with improvements of over 0.5 standard deviations observed in a study of 199 parent-child dyads.

The effectiveness of CPP was influenced by factors such as the number of parental lifetime stressors and clinician expertise, indicating that treatment outcomes can vary based on individual and treatment characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent and Child Trauma Symptoms During Child-Parent Psychotherapy: A Prospective Cohort Study of Dyadic Change. Hagan, MJ., Browne, DT., Sulik, M., et al.[2018]

The Strength at Home - Parents (SAHP) intervention shows promise in improving parenting behaviors and parent-child functioning among veterans with PTSD, based on pilot data from 21 participants.

Participants reported improved family functioning, reduced dysfunctional parenting practices, and increased positive parenting practices, indicating the intervention's potential effectiveness, although results should be interpreted cautiously due to the small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot trial of Strength at Home Parents, a trauma-informed parenting support treatment for veterans. Creech, SK., Pearson, R., Saenz, JJ., et al.[2023]

The study developed a new intervention aimed at reducing PTSD symptoms and improving maternal-infant interactions for mothers of premature infants, showing it is feasible and well-received by participants.

While the initial results are promising, indicating high fidelity and satisfaction, further research with larger sample sizes and control groups is needed to confirm the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of postpartum traumatic stress in mothers with preterm infants: manual development and evaluation. Shaw, RJ., Sweester, CJ., St John, N., et al.[2021]

In a study involving 47 youth aged 7-18 with PTSD, it was found that as children's PTSD symptoms improved through cognitive behavioral therapy, their mothers' depression symptoms also significantly decreased, indicating a beneficial reciprocal relationship.

The results suggest that treating PTSD in children not only helps them but can also positively impact their parents' mental health, highlighting the importance of considering family dynamics in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CBT for Child PTSD is Associated with Reductions in Maternal Depression: Evidence for Bidirectional Effects. Neill, EL., Weems, CF., Scheeringa, MS.[2019]

In a study of 78 community mothers, those with PTSD exhibited greater lax parenting behaviors, which were linked to difficulties in regulating their emotions, indicating that emotion dysregulation plays a key role in dysfunctional parenting.

The findings suggest that interventions aimed at improving emotion regulation in mothers with PTSD could enhance their parenting effectiveness and positively impact child development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic Stress and Parenting Behaviors: The Mediating Role of Emotion Regulation. Kumar, SA., Franz, MR., Brock, RL., et al.[2022]

In a study of 431 Israeli mothers and children exposed to trauma, maternal emotion regulation was found to mediate the relationship between maternal posttraumatic stress symptoms and children's emotional dysregulation, indicating that how mothers manage their emotions can significantly impact their children's emotional health.

The findings suggest that improving mothers' emotion regulation skills after trauma could be crucial for preventing emotional regulation problems in their children, highlighting the importance of targeted clinical interventions for families affected by trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion regulation in mothers and young children faced with trauma. Pat-Horenczyk, R., Cohen, S., Ziv, Y., et al.[2015]

The study of 49 asylum-seeker and refugee mothers and their children found that higher maternal posttraumatic stress symptoms are linked to increased psychosocial problems in infants, although these symptoms do not affect the infants' mental or psychomotor development.

Maternal trauma symptoms were associated with less sensitive and more hostile parent-child interactions, leading to infants showing lower responsiveness to their mothers, indicating a need for improved emotional attunement between mothers and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

War trauma lingers on: Associations between maternal posttraumatic stress disorder, parent-child interaction, and child development. van Ee, E., Kleber, RJ., Mooren, TTM.[2022]

The Parental PTSD Questionnaire (PPQ) was developed to assess PTSD symptoms in parents, and it showed high interrater reliability when compared to the Clinician Administered PTSD Scale (CAPS) in a study of 58 adult offspring of Holocaust survivors.

The results indicated that the PPQ effectively captured the presence of PTSD symptoms, with 56.9% of participants able to provide estimates for all 17 symptoms, suggesting it could be a useful tool for further research into parental PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are adult offspring reliable informants about parental PTSD? A validation study. Yehuda, R., Labinsky, E., Tischler, L., et al.[2015]

The Parenting-STAIR intervention, which combines skills training and narrative therapy, was delivered to 111 mothers in New York City, showing promising results in reducing maternal PTSD and improving parenting skills, with 70 mothers completing the treatment.

Statistically significant improvements were observed in maternal PTSD, depression, parenting stress, and child behaviors, indicating that Parenting-STAIR may be a feasible and effective approach for supporting mothers in the child welfare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Impact of a Community-Based Intervention for Maternal PTSD and Parenting: Parenting-STAIR Pilot. Sullivan, KS., Ancharski, K., Wortham, W., et al.[2023]

In a study of 52 mother-infant pairs, maternal PTSD symptoms were linked to difficulties in infants' emotion regulation as early as 6 months old, indicating that maternal mental health can significantly impact infant development.

The research found that maternal PTSD predicted various emotional and behavioral symptoms in infants by 13 months, suggesting that these early regulation difficulties could increase the risk of future mental health issues in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal posttraumatic stress symptoms and infant emotional reactivity and emotion regulation. Bosquet Enlow, M., Kitts, RL., Blood, E., et al.[2022]

Citations

1. link.springer.com link.springer.com/article/10.1007/s10826-023-02534-y

Parenting-STAIR Pilot | Journal of Child and Family Studies This open pilot study aimed to examine the feasibility and preliminary impact of Parenting-STAIR in reducing maternal PTSD and increasing positive parenting ...

2. reporter.nih.gov reporter.nih.gov/project-details/10888608

Parenting STAIR - NIH RePORTER In an open pilot with child-welfare involved mothers, 23 session PSTAIR dramatically reduced symptoms, improved parenting skills, and prevented maltreatment.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468749924001169

Skills training in affective and interpersonal regulation ... In a review of seven studies, STAIR therapy for CPTSD showed significant symptom reduction, with effect sizes ranging from d = 1.34 to 2.29 in clinician ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06262178

Adapting a Trauma-Focused Parenting Intervention for ... The goal of this study is to assess Parenting STAIR Modular (PSTAIR-M), a promising and innovative intervention for military-connected mothers (MCM) who ...

5. researchgate.net researchgate.net/publication/360795612_A_randomized_controlled_trial_to_assess_the_efficacy_of_Parenting-STAIR_in_treating_maternal_PTSD_to_reduce_maltreatment_recidivism_protocol_for_the_Safe_Mothers_Safe_Children_study

(PDF) A randomized controlled trial to assess the efficacy ... The combined intervention, Parenting-STAIR (P-STAIR), targets maternal PTSD and comorbid depression symptoms to reduce the adverse effects of PTSD on parenting ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9186357/

Skills Training in Affective and Interpersonal Regulation ... This pilot study examined the feasibility, safety, and outcomes of SNT for CPTSD among women with a history of childhood abuse in a Japanese clinical setting.