Clinical trial NCT05606172: Adaptation of the PCIP for Children Aged 6 to 11
Official title: Adaptation of the Primary Care Intervention for PTSD for Children Aged 6 to 11
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Post-Traumatic Stress Disorder in Children
Post-traumatic Stress Disorder
Keywords: Children
Primary Care
PTSD
Post Traumatic Stress Disorder
Randomized Pilot Feasibility Trial
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control).
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in PTSD Knowledge
timeFrame: Day 0 baseline, 3 months
measure: Change in Self-Reported Arousal
timeFrame: Day 0 baseline, 3 months
measure: Intervention Acceptability
timeFrame: 1 month
measure: Intervention Engagement
timeFrame: 1 month
measure: Intervention Implementation
timeFrame: 1 month
Secondary outcomes:
measure: Change in PTSD and Trauma Symptoms
timeFrame: Day 0 baseline, 3 months
measure: Change in Depression Symptoms
timeFrame: Day 0 baseline, 3 months
measure: Change in Anxiety Symptoms
timeFrame: Day 0 baseline, 3 months
measure: Change in Positive Parenting Practices
timeFrame: Day 0 baseline, 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
affiliation: UCLA Psychology
name: Lauren C Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References: