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Adaptation of the PCIP for Children Aged 6 to 11

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11
Waitlist Treatment as Usual
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder in Children focused on measuring Children, Primary Care, PTSD, Post Traumatic Stress Disorder, Randomized Pilot Feasibility Trial

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • University of California Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PCIP for youth aged 6 to 11

Waitlist Treatment as Usual

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in PTSD Knowledge
Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)
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)
Intervention Acceptability
Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.
Intervention Engagement
Data will be collected regarding participant completion of therapy, no show rates, and attendance.
Intervention Implementation
Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.

Secondary Outcome Measures

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).
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).
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).
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).

Full Information

First Posted
October 28, 2022
Last Updated
May 24, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05606172
Brief Title
Adaptation of the PCIP for Children Aged 6 to 11
Official Title
Adaptation of the Primary Care Intervention for PTSD for Children Aged 6 to 11
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder in Children, Post-traumatic Stress Disorder
Keywords
Children, Primary Care, PTSD, Post Traumatic Stress Disorder, Randomized Pilot Feasibility Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCIP for youth aged 6 to 11
Arm Type
Experimental
Arm 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.
Arm Title
Waitlist Treatment as Usual
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PTSD Knowledge
Description
Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)
Time Frame
Day 0 baseline, 3 months
Title
Change in Self-Reported Arousal
Description
Changes in PTSD related arousal levels measured by the Self-Assessment Manikin (SAM; 0-24, higher scores indicating higher arousal)
Time Frame
Day 0 baseline, 3 months
Title
Intervention Acceptability
Description
Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.
Time Frame
1 month
Title
Intervention Engagement
Description
Data will be collected regarding participant completion of therapy, no show rates, and attendance.
Time Frame
1 month
Title
Intervention Implementation
Description
Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change in PTSD and Trauma Symptoms
Description
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).
Time Frame
Day 0 baseline, 3 months
Title
Change in Depression Symptoms
Description
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).
Time Frame
Day 0 baseline, 3 months
Title
Change in Anxiety Symptoms
Description
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).
Time Frame
Day 0 baseline, 3 months
Title
Change in Positive Parenting Practices
Description
Changes in positive Parenting Practices measured by the Alabama Parenting Questionnaire (total 45-210, Higher scores indicating higher instances more positive parenting).
Time Frame
Day 0 baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gray K Bowers, MA
Phone
(310) 810-8553
Email
graybowers@ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren C Ng, PhD
Phone
310-794-9137
Email
Laurenng@ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren C Ng, PhD
Organizational Affiliation
UCLA Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gray Bowers, MA
Phone
310-810-8553
Email
graybowers@ucla.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Adaptation of the PCIP for Children Aged 6 to 11

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