Adaptation of the PCIP for Children Aged 6 to 11

Post-traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606172
• Other study ID #: 22-001441
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: August 15, 2025

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: Gray K Bowers, MA
• Phone: (310) 810-8553
• Email: graybowers[@]ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Post-Traumatic Stress Disorder in Children
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Intervention Acceptability	Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.	1 month
Primary	Intervention Engagement	Data will be collected regarding participant completion of therapy, no show rates, and attendance.	1 month
Primary	Intervention Implementation	Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.	1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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