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Clinical Trials/NCT05606172
NCT05606172
Withdrawn
Not Applicable

Adaptation of the Primary Care Intervention for PTSD for Children Aged 6 to 11

University of California, Los Angeles1 site in 1 country20 target enrollmentMay 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Traumatic Stress Disorder in Children
Sponsor
University of California, Los Angeles
Enrollment
20
Locations
1
Primary Endpoint
Intervention Implementation
Status
Withdrawn
Last Updated
8 months ago

Overview

Brief 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:

  1. 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)
  2. 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
August 1, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lauren Ng, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • Patient referred to the SHARK Program
  • Patients must be at least 6 years old
  • The patient's legal guardian is able and willing to provide informed consent for the patient to participate in the study;
  • Patient is able to complete study activities in English.

Exclusion Criteria

  • Suicidal ideation with a plan within the last two weeks or a suicide attempt within the past 30 days;
  • Inability to provide informed consent or assent, and/or complete procedures in English.
  • Patient is over the age of 11

Outcomes

Primary Outcomes

Intervention Implementation

Time Frame: 1 month

Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.

Change in PTSD Knowledge

Time Frame: Day 0 baseline, 3 months

Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)

Intervention Acceptability

Time Frame: 1 month

Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.

Intervention Engagement

Time Frame: 1 month

Data will be collected regarding participant completion of therapy, no show rates, and attendance.

Change in Self-Reported Arousal

Time Frame: Day 0 baseline, 3 months

Changes in PTSD related arousal levels measured by the Self-Assessment Manikin (SAM; 0-24, higher scores indicating higher arousal)

Secondary Outcomes

  • Change in Depression Symptoms(Day 0 baseline, 3 months)
  • Change in Anxiety Symptoms(Day 0 baseline, 3 months)
  • Change in PTSD and Trauma Symptoms(Day 0 baseline, 3 months)
  • Change in Positive Parenting Practices(Day 0 baseline, 3 months)

Study Sites (1)

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