TF-CBT vs TST for Post-Traumatic Stress Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Aaron Reliford

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NYU Langone Health

Disqualifiers: Intellectual disability, Active suicidality, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Investigators plan to offer two evidence based interventions - Trauma Focused Cognitive Behavioral Therapy (CBT) (TF-CBT) and Trauma Systems therapy (TST) to traumatized children and their families. The investigators are looking to evaluate the effectiveness of these interventions in the context of additional stress related to racialized trauma and acculturation stress

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment TF-CBT for Post-Traumatic Stress Disorder?

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is well-supported as an effective treatment for children and adolescents with posttraumatic stress symptoms, and it is considered a gold standard treatment for childhood PTSD in Western countries. It involves both the child and their parents, helping them manage trauma responses and improve emotional regulation. ^{1 2 3 4 5}

Is Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) or Trauma Systems Therapy (TST) safe for treating PTSD?

The provided research articles do not contain specific safety information about Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) or Trauma Systems Therapy (TST) for PTSD or other conditions. ^{6 7 8 9 10}

How is TF-CBT different from other treatments for PTSD?

TF-CBT is unique because it combines cognitive-behavioral principles with exposure techniques and involves both the child and a supportive caregiver in the therapy process. It is structured around eight components, summarized by the acronym P.R.A.C.T.I.C.E, and is considered a first-line treatment for children and adolescents with PTSD. ^{1 2 3 4 11}

Research Team

Aaron Reliford

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for children and adolescents aged 5-17 who have experienced trauma leading to emotional issues like PTSD, along with a parent or guardian. They must be able to consent to the study. It's not for those at immediate risk of harm to self or others, or individuals with an intellectual disability (IQ<70).

Inclusion Criteria

I am a child/teen (5-17) with emotional issues due to trauma, and I have a parent/guardian.

I am able and willing to give my consent for treatment.

Exclusion Criteria

Individual with active suicidality, homicidality, or other symptoms at the time of enrollment that warrants hospitalization

My IQ is below 70, indicating an intellectual disability.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments including TSDS, SAFE, BAS, MEIM-6, and CATS scores are conducted

1 day

1 visit (in-person)

Treatment

Participants receive either Trauma Focused CBT (TF-CBT) or Trauma Systems Therapy (TST) for trauma intervention

3-4 months

Weekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including TSDS, SAFE, BAS, MEIM-6, and CATS scores

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Trauma Focused CBT (TF-CBT) (Behavioral Intervention)
• Trauma Systems therapy (TST) (Behavioral Intervention)

Trial Overview The trial is testing Trauma Focused Cognitive Behavioral Therapy (TF-CBT) and Trauma Systems Therapy (TST) in treating trauma in kids. It aims to see how well these therapies work when considering additional stress from racial issues and adapting to new cultures.

Participant Groups

Group I: Trauma Systems therapy (TST) Experimental Treatment 1 Intervention

Patients and families randomized to engage in TST.

Group II: Trauma Focused CBT (TF-CBT) Experimental Treatment 1 Intervention

Patients and families randomized to engage in TF-CBT.

Trauma Focused CBT (TF-CBT) is already approved in Canada for the following indications:

Approved in Canada as Trauma-Focused Cognitive Behavioral Therapy for:

• Post-traumatic stress disorder (PTSD) in children and adolescents
• Trauma-related symptoms

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NYU Langone Health New York, NY

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1431

Patients Recruited

838,000+

Substance Abuse and Mental Health Services Administration (SAMHSA)

Collaborator

Trials

31

Patients Recruited

23,300+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a Plasticity-Focused Serious Game Intervention for Posttraumatic Stress Disorder: User Requirements Analysis. Jones, M., Denisova, A., Mitchell, S., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Trauma-Focused Cognitive Behavioral Therapy for Children and Adolescents: A Randomized Controlled Trial in Eight German Mental Health Clinics. Goldbeck, L., Muche, R., Sachser, C., et al.[2022]

Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) is a highly effective treatment for reducing posttraumatic stress symptoms in children, supported by high-level evidence from ten randomized controlled trials (RCTs).

While TF-CBT shows promise in addressing trauma-related symptoms, its effectiveness in reducing behavioral problems and depression symptoms remains less certain, highlighting the need for further research to optimize its application across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. de Arellano, MA., Lyman, DR., Jobe-Shields, L., et al.[2022]

Trauma-focused cognitive behavioral therapy (TF-CBT) has been shown to be effective in treating trauma-related symptoms and improving psychosocial functioning in children and adolescents affected by conflict in low- and middle-income countries, based on a systematic review of 11 studies involving 1,354 participants.

Most studies were conducted in low-resource settings in East or Central Africa, where cultural adaptations were made to the TF-CBT delivery, highlighting the importance of tailoring interventions to meet local needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive behavioral therapy for children and youth in low and middle-income countries: A systematic review. Thomas, FC., Puente-Duran, S., Mutschler, C., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused Cognitive Behavior Therapy for Traumatized Children and Families. Cohen, JA., Mannarino, AP.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interpretation of ASTCT Consensus Responses by Chimeric Antigen Receptor T Cell Therapy CRS/ICANS--Review]. Fu, CC., Wang, RJ., Wu, DP.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice comparisons between accelerated resolution therapy, eye movement desensitization and reprocessing and cognitive processing therapy with case examples. Hernandez, DF., Waits, W., Calvio, L., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pharmacology of T Cell Therapies. Milone, MC., Bhoj, VG.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The toxicity of cell therapy: Mechanism, manifestations, and challenges. Jin, Y., Dong, Y., Zhang, J., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiotoxicity Associated With Chimeric Antigen Receptor (CAR)-T Cell Therapy for Hematologic Malignancies: A Systematic Review. Hanna, KS., Kaur, H., Alazzeh, MS., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Trauma-focused Cognitive-behavioral Therapy with children and adolescents: Practice, evidence base, and future directions]. Sachser, C., Rassenhofer, M., Goldbeck, L.[2018]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Acceptability of a Plasticity-Focused Serious Game Intervention for Posttraumatic Stress Disorder: User Requirements Analysis. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Trauma-Focused Cognitive Behavioral Therapy for Children and Adolescents: A Randomized Controlled Trial in Eight German Mental Health Clinics. [2022]

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

Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive behavioral therapy for children and youth in low and middle-income countries: A systematic review. [2022]

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

Trauma-focused Cognitive Behavior Therapy for Traumatized Children and Families. [2018]

6. China pubmed.ncbi.nlm.nih.gov

[Interpretation of ASTCT Consensus Responses by Chimeric Antigen Receptor T Cell Therapy CRS/ICANS--Review]. [2021]

7. Scotland pubmed.ncbi.nlm.nih.gov

Practice comparisons between accelerated resolution therapy, eye movement desensitization and reprocessing and cognitive processing therapy with case examples. [2018]

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

The Pharmacology of T Cell Therapies. [2020]

9. England pubmed.ncbi.nlm.nih.gov

The toxicity of cell therapy: Mechanism, manifestations, and challenges. [2021]

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

Cardiotoxicity Associated With Chimeric Antigen Receptor (CAR)-T Cell Therapy for Hematologic Malignancies: A Systematic Review. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Trauma-focused Cognitive-behavioral Therapy with children and adolescents: Practice, evidence base, and future directions]. [2018]