Therapy for Adverse Childhood Experiences

No longer recruiting at 3 trial locations

Overseen By Karli S. Okeson, DO

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Outpatient therapy, Critically ill, Developmental delays

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether telehealth therapy (also known as virtual therapy or online counseling) helps children with adverse childhood experiences (traumatic events) follow up with mental health services more effectively than in-person therapy (also known as psychotherapy or talk therapy). The study aims to improve long-term health by making mental health care more accessible. It involves two groups: one receiving therapy via video calls and the other attending in-person sessions. The trial seeks participants aged 12-17 who have visited a pediatric emergency department and do not already have ongoing therapy. As an unphased trial, this study offers a unique opportunity to contribute to research that could make mental health care more accessible for many children.

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

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that telehealth therapy is generally safe for children with adverse childhood experiences (ACEs). One study found that online therapy, even when not conducted live, is safe and effective for children who have experienced trauma. Another study surveyed therapists about teletherapy and found it promising, particularly for children who have faced challenges. While these studies focused on online therapy, in-person therapy has long been a trusted and effective method for helping children with ACEs. Overall, both online and in-person therapies are safe options for managing ACEs in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these therapies for addressing adverse childhood experiences because they offer flexible and accessible options. Unlike traditional in-person therapy, telehealth therapy allows individuals to receive support remotely, removing barriers like travel and scheduling conflicts. This approach can be especially beneficial for those in remote or underserved areas, making mental health care more inclusive. Both therapies aim to provide effective support, but telehealth stands out for its potential to reach a broader audience without compromising the quality of care.

What evidence suggests that this trial's treatments could be effective for adverse childhood experiences?

This trial will compare telehealth therapy with in-person therapy for children who have experienced trauma. Research has shown that telehealth therapy can effectively help these children. Studies have found telehealth to be practical, making mental health support more accessible. One study specifically examined telehealth therapy focused on trauma and found it useful for managing posttraumatic stress in children. Additionally, a national survey of therapists highlighted that teletherapy can address challenges of in-person therapy, such as transportation and scheduling. Overall, telehealth is a promising option that can make therapy more accessible and efficient for children who have faced difficult experiences. ^{1 2 4 6 7}

Who Is on the Research Team?

Karli S. Okeson, DO

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for children who have experienced traumatic events known as Adverse Childhood Experiences (ACEs) and are seen in pediatric emergency departments. The study aims to help these families by connecting them with mental health resources.

Exclusion Criteria

Patients already enrolled in outpatient therapy resources

Critically ill patients

Patients with significant developmental delays impeding their ability to participate in therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Enrollment and Consent

Children and their legal guardians fill out electronic consent/assent and survey

1 day

1 visit (in-person)

Randomization and Intervention

Participants are randomized to in-person or telehealth therapy and referred to mental health services

24 weeks

Follow-up

Study team contacts family and mental health team to assess appointment attendance and therapy initiation

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• In-person therapy
• Telehealth therapy

Trial Overview The study is testing whether offering telehealth therapy improves follow-up rates with mental health services compared to only providing the option of in-person therapy for children with high ACE scores.

How Is the Trial Designed?

Group I: Telehealth Experimental Treatment 1 Intervention

Group II: In-person therapy Active Control 1 Intervention

In-person therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Psychotherapy for:

• Mental health disorders
• Trauma
• Anxiety
• Depression

Approved in European Union as Psychotherapy for:

• Mental health disorders
• Trauma
• Anxiety
• Depression
• Personality disorders

Approved in Canada as Psychotherapy for:

• Mental health disorders
• Trauma
• Anxiety
• Depression
• Post-traumatic stress disorder

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

Prolonged exposure therapy (PE) for PTSD was effective regardless of whether it was delivered through home-based telehealth, office-based telehealth, or in-home in-person sessions, indicating that all modalities can be used effectively for treatment.

However, veterans receiving treatment via telehealth (both HBT and OBT) had significantly higher dropout rates compared to those receiving in-home in-person therapy, suggesting that in-person care may enhance treatment retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based delivery of variable length prolonged exposure therapy: A comparison of clinical efficacy between service modalities. Morland, LA., Mackintosh, MA., Glassman, LH., et al.[2020]

A study comparing outpatient and telehealth cognitive processing therapy (CPT) and prolonged exposure (PE) therapy for PTSD in veterans showed that both methods led to clinically significant improvements in PTSD symptoms, indicating their effectiveness.

Telehealth may be a particularly valuable option for veterans facing barriers to accessing care due to geographic distance, suggesting it could help increase the utilization of mental health services among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of PTSD telehealth treatment in a VA clinical sample. Wierwille, JL., Pukay-Martin, ND., Chard, KM., et al.[2019]

In a study of 252 patients at a hospital-based outpatient psychiatric clinic, the average number of adverse childhood experiences (ACEs) was 3.4, significantly higher than the national average of 1.6, indicating a high prevalence of trauma in this population.

The presence of ACEs was strongly correlated with more severe psychiatric conditions, including a greater number of diagnoses, higher rates of substance use disorders, and increased suicide risk, highlighting the impact of childhood adversity on adult mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights from Expanded Adverse Childhood Experiences Screening in a Hospital-Based Outpatient Psychiatry Service. Jiang, DH., Kim, S., Zaidi, A., et al.[2023]

Energy psychology, which combines traditional therapeutic techniques with acupoint tapping, shows promise in treating conditions related to adverse childhood experiences (ACEs) by potentially enhancing the speed and effectiveness of therapeutic outcomes.

The review highlights the importance of a mind-body approach in therapy for ACE-related conditions, suggesting that it may address both psychological and physical aspects of trauma more effectively than conventional therapies alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using energy psychology to remediate emotional wounds rooted in childhood trauma: preliminary clinical guidelines. Feinstein, D.[2023]

Cognitive-behavioral therapy (CBT) has the strongest evidence for effectively improving outcomes in children aged 3-18 who have experienced Adverse Childhood Experiences (ACEs), particularly those related to abuse.

Overall, while some psychological therapies and parent training show positive results, many interventions lack conclusive evidence, and there is a significant gap in addressing the broader social factors that contribute to the negative impacts of ACEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to support people exposed to adverse childhood experiences: systematic review of systematic reviews. Lorenc, T., Lester, S., Sutcliffe, K., et al.[2020]

A study involving 207 veterans with PTSD found that cognitive processing therapy (CPT) delivered via videoconference (VC) was as effective as in-person (IP) therapy in reducing PTSD symptoms at a six-month follow-up, indicating that VC can be a viable treatment option.

While VC showed non-inferiority to IP for long-term symptom improvement, it was less effective immediately after treatment, suggesting that in-person therapy may provide quicker benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Videoconferencing psychotherapy for veterans with PTSD: Results from a randomized controlled non-inferiority trial. Liu, L., Thorp, SR., Moreno, L., et al.[2021]

A randomized controlled trial comparing Web-PE (a web-based Prolonged Exposure Therapy) to in-person Present-Centered Therapy (PCT) showed no significant difference in effectiveness for reducing PTSD symptoms, although more participants in the PCT group achieved clinically significant improvements.

In an uncontrolled open trial with 34 service members, Web-PE demonstrated significant reductions in PTSD symptoms, suggesting that it may be particularly effective for individuals specifically seeking web-based treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of web-prolonged exposure among military personnel and veterans with posttraumatic stress disorder. McLean, CP., Foa, EB., Dondanville, KA., et al.[2022]

The ongoing randomized controlled trials are comparing the effectiveness of in-person psychotherapy versus video teleconferencing psychotherapy for military veterans with posttraumatic stress disorder (PTSD).

The study aims to evaluate not only the efficacy of these two delivery methods but also to share insights on training, technology use, and the challenges faced during the trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from studies of psychotherapy for posttraumatic stress disorder via video teleconferencing. Thorp, SR., Fidler, J., Moreno, L., et al.[2012]

Minimally guided internet-based cognitive behavior therapy (iCBT) for PTSD showed significant reductions in symptom severity in both a randomized control trial (21 participants) and an open trial (117 participants), with effect sizes indicating moderate to large improvements.

The iCBT group maintained their symptom improvements at a 3-month follow-up, suggesting its potential effectiveness, although the randomized control trial's between-group comparison did not reach statistical significance, indicating the need for further research on clinician support levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive behaviour therapy for post-traumatic stress disorder: a randomised controlled trial and outcomes in routine care. Allen, AR., Smith, J., Hobbs, MJ., et al.[2022]

A four-year randomized controlled trial is underway to compare the effectiveness of in-person Prolonged Exposure therapy for PTSD with therapy delivered via home-based telehealth technology, addressing concerns about safety and treatment efficacy.

Home-based telehealth may improve access to evidence-based psychotherapies for veterans with PTSD, who often face barriers to receiving traditional in-person treatment, potentially leading to better mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based telehealth to deliver evidence-based psychotherapy in veterans with PTSD. Strachan, M., Gros, DF., Yuen, E., et al.[2022]

In a study of 367 children aged 0-11, those who reported higher levels of Adverse Childhood Experiences (ACEs) were linked to poorer health outcomes, including worse general health and increased likelihood of stomachaches and asthma.

The study found that using aggregate-level screening for ACEs led to participants disclosing more adversities compared to item-level screening, highlighting the importance of effective screening methods in identifying at-risk children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatrics adverse childhood experiences and related life events screener (PEARLS) and health in a safety-net practice. Thakur, N., Hessler, D., Koita, K., et al.[2022]

In a study of 856 patients at a community mental health center, 40% reported experiencing four or more Adverse Childhood Experiences (ACEs), with emotional abuse, physical abuse, and emotional neglect being the most common.

Higher ACE scores were linked to increased rates of co-occurring psychiatric disorders such as PTSD, depression, and substance use disorder, highlighting the importance of trauma-informed care in mental health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Childhood Trauma in a Community-Based Mental Health Clinic. Sucich, J., Breitbart, V., Williams, S., et al.[2023]

Home-based telemental health (TMH) therapy for youth requires specific clinical, logistical, and safety procedures to address unique challenges, as highlighted in the Targeted Approach to Safer Use of Antipsychotics in Youth (SUAY) study involving youth ages 3-17.

Key adaptations include ensuring privacy during sessions, planning for crises, and providing technological support, which are essential for optimizing care and safety in a non-traditional therapy setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing home-based telemental health services for youth: Practices from the SUAY Study. Schoenfelder Gonzalez, E., Myers, K., Thompson, EE., et al.[2021]

In an open trial with 458 patients, Internet-delivered cognitive behavior therapy (ICBT) showed significant reductions in anxiety and depression symptoms, with large effect sizes ranging from 1.17 to 1.31, indicating its efficacy.

The study found that ICBT delivered in both specialized online clinics and nonspecialized community clinics resulted in similar high completion rates and patient satisfaction, suggesting that ICBT can be effectively implemented in various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdiagnostic Internet-delivered cognitive behaviour therapy in Canada: An open trial comparing results of a specialized online clinic and nonspecialized community clinics. Hadjistavropoulos, HD., Nugent, MM., Alberts, NM., et al.[2022]

The Improving Access to Psychological Therapies (IAPT) service in the UK effectively monitors and reports clinical outcomes for over 537,000 patients annually, revealing that specific organizational factors, such as the number of treatment sessions and timely access to care, significantly predict better mental health outcomes.

Improvements in service organization could enhance clinical outcomes by 11-42%, indicating that how psychological therapies are delivered is as crucial as the treatments themselves, and this model could be beneficial for mental health services globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transparency about the outcomes of mental health services (IAPT approach): an analysis of public data. Clark, DM., Canvin, L., Green, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11545140/

Telehealth Outreach Program for Child Traumatic Stress Research on the relationship between adverse childhood experiences and adult health outcomes shows strong connections between stress and ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190740923000142

A national survey of clinicians The current study was designed to ascertain challenges and opportunities presented by the widescale usage of teletherapy especially for traumatized children.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10071250/

Examining the Feasibility of Telehealth Trauma-Focused ... Feasibility and effectiveness of a telehealth service delivery model for treating childhood posttraumatic stress: A community-based, open ...

4. i-jmr.org i-jmr.org/2023/1/e47250

Phone-Based Text Therapy for Youth Mental Health This rapid review aims to understand the clinical effectiveness, usability, and accessibility of phone-based text therapy for youth mental health.

5. tandfonline.com tandfonline.com/doi/full/10.1080/09638237.2024.2332797

The development and evaluation of a virtual, asynchronous ... Our research findings suggest that an asynchronous virtual intervention for childhood interpersonal trauma survivors may be a safe and acceptable way

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9493451/

Coping with adverse childhood experiences during the ... This study assessed the perspectives of mental health providers (MHPs) regarding their adult patients' coping with ACEs during COVID-19 in Houston, Texas.

7. bmjopen.bmj.com bmjopen.bmj.com/content/15/6/e102710

trial protocol Childhood abuse, household dysfunction, and the risk of attempted suicide throughout the life span: findings from the Adverse Childhood Experiences Study.