Adaptation of the PCIP for Children Aged 6 to 11

University of California, Los Angeles (UCLA)

Status: Withdrawn

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

Treatments: Behavioral: Waitlist Treatment as Usual; Behavioral: Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11

Study type: Interventional

Funder types: Other

Identifiers

NCT05606172

22-001441

Details and patient eligibility

About

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.

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

PCIP for youth aged 6 to 11

Experimental group

Description:

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.

Treatment:

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

Waitlist Treatment as Usual

Active Comparator group

Description:

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.

Treatment:

Behavioral: Waitlist Treatment as Usual