Adaptation of the PCIP for Children Aged 6 to 11

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-traumatic Stress Disorder; Post-Traumatic Stress Disorder in Children
• Intervention / Treatment: Behavioral: Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11; Behavioral: Waitlist Treatment as Usual

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren C Ng, PhD; Phone Number: 310-794-9137; Email: laurenng@ucla.edu
• Study Contact Backup: Name: Gray K Bowers, MA; Phone Number: (310) 810-8553; Email: graybowers@ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California Los Angeles
      • Contact: Gray Bowers, MA; Phone Number: 310-810-8553; Email: graybowers@ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCIP for youth aged 6 to 11; This arm will receive the adapted PCIP intervention lasting from 1-4 weeks, and will complete baseline, post treatment, 1-month, and 3-month follow up assessments.	Behavioral: Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11; 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.
Active Comparator: Waitlist Treatment as Usual; Receive standard care treatment and will complete baseline, post treatment, 1-month, and 3-month follow up assessments, and are offered PCIP treatment after conclusion of the study.	Behavioral: Waitlist Treatment as Usual; Will receive treatment as usual at local clinic and are provided information on free or low cost mental health care referrals in the Los Angeles Area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD Knowledge	Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)	Day 0 baseline, 3 months
Change in Self-Reported Arousal	Changes in PTSD related arousal levels measured by the Self-Assessment Manikin (SAM; 0-24, higher scores indicating higher arousal)	Day 0 baseline, 3 months
Intervention Acceptability	Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.	1 month
Intervention Engagement	Data will be collected regarding participant completion of therapy, no show rates, and attendance.	1 month
Intervention Implementation	Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD and Trauma Symptoms	Changes in trauma related symptoms measured by Child and Adolescent Trauma Screen (CATS) Self Report and Caregiver report (total 0-60, Higher scores indicated greater symptom severity).	Day 0 baseline, 3 months
Change in Depression Symptoms	Changes in depression symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-DC) Self Report (total 0-60, Higher scores indicate higher symptom severity).	Day 0 baseline, 3 months
Change in Anxiety Symptoms	Changes in anxiety symptoms measured by the Revised Children's Anxiety and Depression Scale (RCADS) Self Report (total 0-141, Higher scores indicating higher symptom severity).	Day 0 baseline, 3 months
Change in Positive Parenting Practices	Changes in positive Parenting Practices measured by the Alabama Parenting Questionnaire (total 45-210, Higher scores indicating higher instances more positive parenting).	Day 0 baseline, 3 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Lauren C Ng, PhD, UCLA Psychology

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: PTSD; Primary Care; Children; Post Traumatic Stress Disorder; Randomized Pilot Feasibility Trial
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 22-001441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No