PCIP for youth aged 6 to 11 for Post-traumatic Stress Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Post-traumatic Stress Disorder+4 More
Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11 - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This study will implement a brief Post-traumatic Stress Disorder (PTSD) intervention for children, the Primary Care Intervention for PTSD (PCIP) delivered through telehealth (computer or smartphone delivery), to 10 youth age 6-11 and their caregivers. Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control) to refine the intervention, study procedures, and explore effectiveness. Following RE-AIM guidelines, the investigators will assess: Reach: patient participation in intervention delivery (out of all those asked to participate) and retention rate (out of all those who consented to participate and completed at least two intervention sessions) Adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings. To understand patient experiences with the intervention and to identify and explain positive or negative treatment mechanisms or effects, the investigators will conduct post-intervention semi-structured interviews with the participating patients, their parents/guardians, and with providers. This treatment ranges from 1-4 sessions which last 50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the parent or both the parent and child. The first session will also teach the parent and child a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the child's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that the parent and child can learn together. There is also material for parents to address behavior problems in youth. This treatment will be delivered via telehealth.

Eligible Conditions
  • Post-traumatic Stress Disorder
  • Post-Traumatic Stress Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Post-traumatic Stress Disorder

Study Objectives

5 Primary · 4 Secondary · Reporting Duration: Day 0 baseline, 3 months

Month 1
Intervention Engagement
Month 3
Anxiety
Mental Depression
Post-Traumatic Stress Disorder
Post-Traumatic Stress Disorder
Change in Positive Parenting Practices
Change in Self-Reported Arousal
Intervention Acceptability
Intervention Implementation

Trial Safety

Safety Progress

1 of 3

Other trials for Post-traumatic Stress Disorder

Trial Design

2 Treatment Groups

Waitlist Treatment as Usual
1 of 2
PCIP for youth aged 6 to 11
1 of 2
Active Control
Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: PCIP for youth aged 6 to 11 · No Placebo Group · N/A

PCIP for youth aged 6 to 11
Behavioral
Experimental Group · 1 Intervention: Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11 · Intervention Types: Behavioral
Waitlist Treatment as Usual
Behavioral
ActiveComparator Group · 1 Intervention: Waitlist Treatment as Usual · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 0 baseline, 3 months

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,404 Previous Clinical Trials
6,941,029 Total Patients Enrolled
1 Trials studying Post-traumatic Stress Disorder
20 Patients Enrolled for Post-traumatic Stress Disorder
Lauren C Ng, PhDPrincipal InvestigatorUCLA Psychology

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able and willing to provide informed consent for the patient to participate in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: October 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.