24 Participants Needed

Caregiver Counseling for Childhood Traumatic Injury

(PACTS Trial)

DH
LW
Overseen ByLiz White, MA, LCMHCS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is Caregiver Counseling for Childhood Traumatic Injury safe for humans?

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), which involves caregivers, is considered safe and is a well-established treatment for children with trauma-related symptoms. It is widely used and recognized as a gold standard treatment for childhood trauma, with no significant safety concerns reported in the research.12345

How is Caregiver Counseling for Childhood Traumatic Injury different from other treatments for childhood trauma?

Caregiver Counseling for Childhood Traumatic Injury is unique because it involves both the child and their caregiver in parallel sessions, enhancing the child's ability to manage trauma responses and emotions. This family-focused approach, part of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), emphasizes the caregiver's role in the healing process, which can significantly improve outcomes for traumatized children.13456

What data supports the effectiveness of the treatment Caregiver Counseling for Childhood Traumatic Injury?

Research shows that Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), which involves caregivers, is highly effective for children with trauma, leading to positive outcomes and high caregiver satisfaction. TF-CBT is considered a gold standard treatment for childhood posttraumatic stress disorder (PTSD) and is supported by numerous studies and international guidelines.25678

Who Is on the Research Team?

ES

Elizabeth Shilling, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for children who have experienced a traumatic injury and their caregivers. It aims to help them manage post-traumatic stress disorder (PTSD) or depression following the trauma.

Inclusion Criteria

Caregiver-child dyads who screen positive with the Peritraumatic Distress Inventory (PDI) Tools will be invited to participate in the randomized controlled trial.
My child needs hospital care for an injury like a burn or dog bite.
My primary language is English according to my medical records.

Exclusion Criteria

Patients and/or caregivers with psychotic symptoms
Patients and/or caregivers leaving the hospital against medical advice (AMA)
I or my caregiver have cognitive challenges.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Caregiver-child dyadic screening and intervention during hospitalization to reduce traumatic stress symptoms

During hospitalization
1 visit (in-person)

Follow-up

Participants are monitored for changes in depressive and PTSD symptoms using PHQ-9, Kessler 6, and CATS scores

3 months
Monthly assessments (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Caregiver Counseling for Childhood Traumatic Injury
  • Standard of Care for Childhood Traumatic Injury
Trial Overview The study compares two approaches: one provides special counseling for caregivers of injured children, while the other follows standard care practices after childhood traumatic injuries.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Peritraumatic Distress Inventory (PDI) Tool - Trauma CounselingExperimental Treatment1 Intervention
Group II: Peritraumatic Distress Inventory (PDI) Tool - Standard of CareActive Control1 Intervention

Caregiver Counseling for Childhood Traumatic Injury is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Caregiver Counseling for Childhood Traumatic Injury for:
🇪🇺
Approved in European Union as Caregiver Counseling for Childhood Traumatic Injury for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Childress Institute for Pediatric Trauma

Collaborator

Trials
2
Recruited
270+

Published Research Related to This Trial

Caregivers of children undergoing trauma-focused cognitive-behavioral therapy (TF-CBT) reported high overall satisfaction, particularly valuing the PRACTICE components and positive outcomes for their children.
Caregivers of children who completed TF-CBT had significantly higher satisfaction scores compared to those whose children did not complete treatment, highlighting the importance of addressing caregiver concerns to improve treatment retention.
Caregiver satisfaction with their child's trauma-focused cognitive behavioral therapy.Lange, BCL., Loser, A., Lang, JM.[2021]
Trauma-focused cognitive behavioral therapy (TF-CBT) is an effective family-centered treatment that involves both parents and traumatized children working together to address trauma responses.
Parental involvement in TF-CBT significantly boosts its effectiveness, helping children learn to manage their trauma-related thoughts and feelings more effectively.
Trauma-focused Cognitive Behavior Therapy for Traumatized Children and Families.Cohen, JA., Mannarino, AP.[2018]
Trauma-focused cognitive behavioral therapy (Tf-CBT) is an effective treatment for children and adolescents aged 3-17 with posttraumatic stress disorder (PTSD), supported by 13 randomized controlled trials and recognized as a first-line treatment in international guidelines.
Tf-CBT includes eight key components that help children process trauma and develop coping skills, making it a comprehensive approach that involves both the child and a supportive caregiver in the therapeutic process.
[Trauma-focused Cognitive-behavioral Therapy with children and adolescents: Practice, evidence base, and future directions].Sachser, C., Rassenhofer, M., Goldbeck, L.[2018]

Citations

Caregiver satisfaction with their child's trauma-focused cognitive behavioral therapy. [2021]
Trauma-focused Cognitive Behavior Therapy for Traumatized Children and Families. [2018]
[Trauma-focused Cognitive-behavioral Therapy with children and adolescents: Practice, evidence base, and future directions]. [2018]
Trauma-focused cognitive behavioral therapy for children and youth in low and middle-income countries: A systematic review. [2022]
Trauma-Focused Cognitive Behavioural Therapy for Children and Parents. [2020]
Effectiveness of Trauma-Focused Cognitive Behavioral Therapy for Children and Adolescents: A Randomized Controlled Trial in Eight German Mental Health Clinics. [2022]
Parenting stress and children's trauma symptoms over the course of TF-CBT: Examining differences between relative and foster/adoptive caregivers. [2023]
Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. [2022]
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