Caregiver Counseling for Childhood Traumatic Injury

(PACTS Trial)

Overseen By Liz White, MA, LCMHCS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Cognitive deficits, Psychotic symptoms, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: During hospitalization

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help caregivers and children manage post-traumatic stress and depression after a child experiences a traumatic injury. It will explore whether a special counseling approach, called Caregiver Counseling for Childhood Traumatic Injury, is more effective than standard support. Researchers will divide families into two groups: one will receive trauma-focused counseling, and the other will receive the usual care. To qualify, a child must be hospitalized for an accidental injury, such as a burn or dog bite, and both the child and caregiver should show signs of distress according to a specific screening tool. As an unphased trial, this study offers families the opportunity to access potentially beneficial counseling methods not yet widely available.

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.

What prior data suggests that this counseling method is safe for caregivers and children?

Research has shown that Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is a well-accepted treatment for children who have experienced trauma. This therapy involves caregivers in the process. Studies indicate that TF-CBT effectively reduces trauma-related symptoms in both children and their non-offending caregivers. Reports of negative effects from this therapy are not significant, making it a safe choice for families dealing with trauma. Evidence suggests that TF-CBT is both safe and helpful in supporting children and their caregivers as they recover from traumatic experiences. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to support caregivers of children who have experienced traumatic injuries. Unlike the standard care, which typically involves addressing acute stress and post-traumatic stress in a more general manner, this trial uses the Peritraumatic Distress Inventory (PDI) tool to screen for distress and then provides targeted trauma counseling interventions during hospitalization. By focusing on the caregiver's role in a child's recovery, the trial aims to improve outcomes by enhancing the support system surrounding the child, potentially leading to better long-term recovery.

What evidence suggests that this trial's treatments could be effective for childhood traumatic injury?

This trial will compare Caregiver Counseling for Childhood Traumatic Injury with the Standard of Care for Childhood Traumatic Injury. Research has shown that Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), included in the Caregiver Counseling arm, reduces trauma-related symptoms in children and their caregivers. This therapy involves both the child and the caregiver, helping them manage stress and trauma together. Studies indicate that the caregiver-child relationship greatly influences the effectiveness of trauma treatments. Caregiver involvement is crucial, as it can lead to better outcomes for the child. By focusing on both the child and the caregiver, this counseling aims to improve the mental health of children who have experienced traumatic events. ^{1 2 3 4 6}

Who Is on the Research Team?

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.

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?

Group I: Peritraumatic Distress Inventory (PDI) Tool - Trauma Counseling Experimental Treatment 1 Intervention

Screening using Peritraumatic Distress Inventory (PDI) tool and one or more caregiver intervention during a single hospitalization

Group II: Peritraumatic Distress Inventory (PDI) Tool - Standard of Care Active Control 1 Intervention

Screening using the Peritraumatic Distress Inventory (PDI) tool and standard of care related to acute stress and post-traumatic stress

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:

• Post-Traumatic Stress Disorder (PTSD)
• Depression in caregivers and children following traumatic injury

Approved in European Union as Caregiver Counseling for Childhood Traumatic Injury for:

• Post-Traumatic Stress Disorder (PTSD)
• Depression in caregivers and children following traumatic injury

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

Trauma-focused cognitive behavioural therapy (TF-CBT) is an evidence-based treatment for traumatized children and their parents, supported by various randomized controlled trials and effectiveness studies.

The TF-CBT model is flexible and includes components like stress management, cognitive coping, and trauma processing, which are designed to help children and parents effectively address and heal from traumatic experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-Focused Cognitive Behavioural Therapy for Children and Parents. Cohen, JA., Mannarino, AP.[2020]

Trauma-focused cognitive behavioral therapy (Tf-CBT) significantly reduced posttraumatic stress symptoms in children and adolescents compared to a waiting list control, as shown by a decrease in CAPS-CA scores over 4 months in a study involving 159 participants.

Younger patients and those with fewer comorbid disorders responded better to Tf-CBT, indicating that age and the presence of other mental health issues are important factors in treatment effectiveness.

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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]

In a study involving 130 caregiver-child pairs undergoing Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), both foster/adoptive and biological/relative caregivers showed significant reductions in parenting stress and child trauma symptoms from the start to the end of treatment.

Initially, foster/adoptive caregivers reported more dysfunction in parent-child interactions, while relative caregivers experienced higher personal stress; however, these differences diminished by the end of treatment, indicating that TF-CBT effectively supports both caregiver types in managing stress and improving child outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenting stress and children's trauma symptoms over the course of TF-CBT: Examining differences between relative and foster/adoptive caregivers. Gusler, S., Sprang, G., Eslinger, J.[2023]

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.

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4396183/

Trauma-Focused Cognitive Behavioral Therapy: Assessing ...

TF-CBT is a viable treatment for reducing trauma-related symptoms among some children who have experienced trauma and their nonoffending caregivers.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8765780/

Caregiver Behaviors and Child Distress in Trauma ...

This study aims to identify correlates of four caregiver variables that have been identified as predictors of child outcomes in TF-CBT.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0005796723002073

The bidirectional associations between caregiver and child ...

These findings suggest that caregivers and children can impact each other's responses to a parent-led child trauma-focused treatment.

4.

publications.aap.org

publications.aap.org/pediatrics/article/148/2/e2021052580/179745/Trauma-Informed-Care

Trauma-Informed Care | Pediatrics

Trauma-informed care translates that science to inform and improve pediatric care and outcomes. To practically address trauma and promote ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165032720325763

Trauma-Focused Cognitive-Behavioral Therapy: The role ...

TF-CBT is an evidence-based child and adolescent trauma treatment model that integrally includes non-offending parents or caregivers throughout treatment.

6.

oklahomatfcbt.org

oklahomatfcbt.org/wp-content/uploads/2024/03/Role-of-Caregivers-in-TF-CBT.pdf

The role of caregivers

Parents are often negatively impacted by their child's trauma which may contribute to the child's risk for developing PTSD and related problems.