Combined Therapies for Maternal PTSD

(SMSC Trial)

Overseen by Michael A Lindsey

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: New York University

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests a program that helps mothers with PTSD learn to manage their emotions and improve their interactions with their children. It aims to reduce stress and improve family dynamics for mothers receiving family preservation services.

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.

What data supports the effectiveness of the treatment Combined Therapies for Maternal PTSD?

Research shows that improving a mother's ability to manage emotions can help both her and her child's emotional well-being, especially after trauma. This suggests that treatments focusing on emotion regulation, like P-STAIR and Parent-Child Interaction Therapy, may be effective in addressing maternal PTSD and improving parent-child relationships. ^{1 2 3 4 5}

Is the Parenting-STAIR treatment safe for humans?

The Parenting-STAIR treatment has been tested in a pilot study with 111 mothers, showing significant improvements in maternal PTSD, depression, and parenting skills, suggesting it is safe and beneficial for participants. ^{3 5 6 7 8}

How is the P-STAIR treatment different from other treatments for maternal PTSD?

P-STAIR is unique because it combines skills training in emotion regulation and interpersonal relationships with parent-child interaction therapy, specifically addressing both maternal PTSD symptoms and parenting challenges, which are often not adequately covered by standard PTSD treatments. ^{4 5 6 9 10}

Research Team

Michael A Lindsey

Principal Investigator

New York University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• P-STAIR (Behavioral Intervention)
• Supportive Counseling (Behavioral)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Dr. Fritz François

New York University

Chief Medical Officer

MD from NYU Grossman School of Medicine

Dr. Robert I. Grossman

New York University

Chief Executive Officer since 2007

MD from NYU Grossman School of Medicine

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Maternal posttraumatic stress symptoms and infant emotional reactivity and emotion regulation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

War trauma lingers on: Associations between maternal posttraumatic stress disorder, parent-child interaction, and child development. [2022]

3. England pubmed.ncbi.nlm.nih.gov

CBT for Child PTSD is Associated with Reductions in Maternal Depression: Evidence for Bidirectional Effects. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Emotion regulation in mothers and young children faced with trauma. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Posttraumatic Stress and Parenting Behaviors: The Mediating Role of Emotion Regulation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pilot trial of Strength at Home Parents, a trauma-informed parenting support treatment for veterans. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Are adult offspring reliable informants about parental PTSD? A validation study. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Impact of a Community-Based Intervention for Maternal PTSD and Parenting: Parenting-STAIR Pilot. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Parent and Child Trauma Symptoms During Child-Parent Psychotherapy: A Prospective Cohort Study of Dyadic Change. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Prevention of postpartum traumatic stress in mothers with preterm infants: manual development and evaluation. [2021]