Adaptation of the PCIP for Children Aged 6 to 11

Sponsor

University of California, Los Angeles (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05606172

Collaborator

(none)

Enrollment

Location

Arms

10.4

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Stress Disorder in Children Post-traumatic Stress Disorder	Behavioral: Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11 Behavioral: Waitlist Treatment as Usual	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PCIP for youth aged 6 to 11 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 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.
Active Comparator: Waitlist Treatment as Usual 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 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.

Arm

Intervention/Treatment

Experimental: PCIP for youth aged 6 to 11

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

Active Comparator: Waitlist Treatment as Usual

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

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.

Outcome Measures

Primary Outcome Measures

Change in PTSD Knowledge [Day 0 baseline, 3 months]
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 [Day 0 baseline, 3 months]
Changes in PTSD related arousal levels measured by the Self-Assessment Manikin (SAM; 0-24, higher scores indicating higher arousal)
Intervention Acceptability [1 month]
Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.
Intervention Engagement [1 month]
Data will be collected regarding participant completion of therapy, no show rates, and attendance.
Intervention Implementation [1 month]
Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.

Secondary Outcome Measures

Change in PTSD and Trauma Symptoms [Day 0 baseline, 3 months]
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 [Day 0 baseline, 3 months]
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 [Day 0 baseline, 3 months]
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 [Day 0 baseline, 3 months]
Changes in positive Parenting Practices measured by the Alabama Parenting Questionnaire (total 45-210, Higher scores indicating higher instances more positive parenting).

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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