Therapy for Adverse Childhood Experiences

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

62 Participants Needed

Trial Summary

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.

What data supports the idea that Therapy for Adverse Childhood Experiences is an effective treatment?

The available research shows that therapy, including in-person and telehealth options, is effective for treating conditions like PTSD. For example, studies on veterans with PTSD found that both in-person and video teleconferencing therapy were effective, with no significant differences in outcomes. This suggests that therapy can be a flexible and effective treatment option, even when delivered remotely. Additionally, the IAPT service in the UK, which provides therapy for depression and anxiety, reports positive outcomes for a large number of patients, further supporting the effectiveness of therapy for mental health issues. ^{1 2 3 4 5}

What safety data exists for therapy treatments for adverse childhood experiences?

The safety data for therapy treatments, including in-person and telehealth options, is still being explored. Studies have shown that web-based and home-based telehealth therapies can address logistical barriers and increase access to treatment, especially for PTSD. However, concerns about patient safety, treatment potency, and data security remain, particularly for home-based telehealth. There are no published safety guidelines for youth in home-based telemental health settings. Internet-delivered cognitive behavior therapy (ICBT) has shown high completion rates and satisfaction, with significant symptom reduction in anxiety and depression, indicating its potential for safe and effective public health application. However, more research is needed to fully understand the safety and efficacy of these therapies, especially in non-specialized settings and with minimal clinician guidance. ^{6 7 8 9 10}

Is in-person or telehealth therapy a promising treatment for adverse childhood experiences?

Yes, in-person and telehealth therapy are promising treatments for adverse childhood experiences. These therapies can help people who have faced difficult events in childhood, like abuse or neglect, by providing support and strategies to improve mental health. They are effective in addressing the emotional and psychological impacts of such experiences. ^{11 12 13 14 15}

What is the purpose of this trial?

Adverse childhood experiences (ACEs) are traumatic exposures that can cause many negative health impacts across life. ACEs are common in patients who seek out care in pediatric emergency departments (PEDs); this is an opportunity to connect families with mental health resources to mitigate the effects of ACEs and improve lifelong health. The goal of this study is to determine if children with high ACEs have better rates of follow-up with mental health resources when a telehealth option is provided, as previous research has shown that simply making an in-person follow-up appointment is not very helpful.

Research Team

Karli S. Okeson, DO

Principal Investigator

Emory University

Eligibility Criteria

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

Critically ill patients

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

Patients already enrolled in outpatient therapy resources

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

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]

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]

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]

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]

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]

References

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

Lessons learned from studies of psychotherapy for posttraumatic stress disorder via video teleconferencing. [2012]

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

Home-based delivery of variable length prolonged exposure therapy: A comparison of clinical efficacy between service modalities. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Transparency about the outcomes of mental health services (IAPT approach): an analysis of public data. [2023]

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

Videoconferencing psychotherapy for veterans with PTSD: Results from a randomized controlled non-inferiority trial. [2021]

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

Effectiveness of PTSD telehealth treatment in a VA clinical sample. [2019]

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

Internet-delivered cognitive behaviour therapy for post-traumatic stress disorder: a randomised controlled trial and outcomes in routine care. [2022]

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

The effects of web-prolonged exposure among military personnel and veterans with posttraumatic stress disorder. [2022]

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

Home-based telehealth to deliver evidence-based psychotherapy in veterans with PTSD. [2022]

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

Developing home-based telemental health services for youth: Practices from the SUAY Study. [2021]

10. Netherlands 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. [2022]

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

Insights from Expanded Adverse Childhood Experiences Screening in a Hospital-Based Outpatient Psychiatry Service. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

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

13. England pubmed.ncbi.nlm.nih.gov

Pediatrics adverse childhood experiences and related life events screener (PEARLS) and health in a safety-net practice. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Interventions to support people exposed to adverse childhood experiences: systematic review of systematic reviews. [2020]

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

Prevalence of Childhood Trauma in a Community-Based Mental Health Clinic. [2023]