Adaptation of the PCIP for Children Aged 6 to 11
NCT05606172 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2025-08-06
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.
Conditions
- Post-Traumatic Stress Disorder in Children
- Post-traumatic Stress Disorder
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
University of California, Los Angeles
lead OTHER
Principal Investigators
-
Lauren C Ng, PhD · UCLA Psychology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-05-01
- Primary Completion
- 2025-08-01
- Completion
- 2025-08-01
Countries
- United States
Study Locations
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