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

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{2 4 6 7 8}

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. ^{1 2 6 7 8}

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.

Research Team

Elizabeth Shilling, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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) 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]

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]

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 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]

References

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

Caregiver satisfaction with their child's trauma-focused cognitive behavioral therapy. [2021]

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

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

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. England pubmed.ncbi.nlm.nih.gov

Trauma-Focused Cognitive Behavioural Therapy for Children and Parents. [2020]

6. 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]

7. England 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. [2023]

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

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