Adaptation of the PCIP for Children Aged 6 to 11

NCT05606172 | Withdrawn

• 1 other identifier: 22-001441
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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. 2.Adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings.

Conditions

Post-Traumatic Stress Disorder in Children; Post-traumatic Stress Disorder

Keywords

Children; Primary Care; PTSD; Post Traumatic Stress Disorder; Randomized Pilot Feasibility Trial

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Change in PTSD and Trauma Symptoms

  Day 0 baseline, 3 months

• Change in Depression Symptoms

  Day 0 baseline, 3 months

• Change in Anxiety Symptoms

  Day 0 baseline, 3 months

• Change in Positive Parenting Practices

  Day 0 baseline, 3 months

Study Arms (2)

PCIP for youth aged 6 to 11

EXPERIMENTAL

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

Waitlist Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11 BEHAVIORAL

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.

PCIP for youth aged 6 to 11

Waitlist Treatment as Usual BEHAVIORAL

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.

Waitlist Treatment as Usual

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Lauren C Ng, PhD

  UCLA Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control).

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 4, 2022
• Study Start: May 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)