Post-Traumatic Stress Disorder in ChildrenNCT05606172
Adaptation of the PCIP for Children Aged 6 to 11
A study testing Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11 and Waitlist Treatment as Usual in people with Post-Traumatic Stress Disorder in Children and Post-traumatic Stress Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder in Children, Post-traumatic Stress Disorder
- What is being tested?
- Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11 and Waitlist Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90095
About this study
Official title: Adaptation of the Primary Care Intervention for PTSD for Children Aged 6 to 11
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.
Read more
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.
- Being tested
- Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11, Waitlist Treatment as Usual
- Keywords
- Children, Primary Care, PTSD, Post Traumatic Stress Disorder, Randomized Pilot Feasibility Trial
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11Behavioural
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.
Waitlist Treatment as UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Waitlist Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Knowledge
Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)
Measured: 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)
Measured: Day 0 baseline, 3 months
Intervention Acceptability
Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.
Measured: 1 month
Intervention Engagement
Data will be collected regarding participant completion of therapy, no show rates, and attendance.
Measured: 1 month
Intervention Implementation
Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.
Measured: 1 month
Secondary outcomes (4)
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).
Measured: Day 0 baseline, 3 months
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).
Measured: Day 0 baseline, 3 months
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).
Measured: Day 0 baseline, 3 months
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).
Measured: Day 0 baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 May 2023
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Why it stopped: We secured funding to run a cluster randomized trial and approval from the sponsor to transfer the money for this project to the new larger trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder in ChildrenStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Ng, PhD, University of California, Los Angeles
- Investigators
- Lauren C Ng, PhD, Principal investigator, UCLA Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606172
- Sponsor's protocol ID
- 22-001441
- Status last verified
- Aug 2025
- First submitted
- 28 Oct 2022
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the Primary Care Intervention for PTSD for Children Aged 6 to 11
- ClinicalTrials.gov ID
- NCT05606172
- Acronym / sponsor ID
- 22-001441
- Keywords
- Children, Primary Care, PTSD, Post Traumatic Stress Disorder, Randomized Pilot Feasibility Trial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We secured funding to run a cluster randomized trial and approval from the sponsor to transfer the money for this project to the new larger trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control).
| Arm | Type | Receives |
|---|---|---|
| PCIP for youth aged 6 to 11 | Experimental | Behavioral: Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11This 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. |
| Waitlist Treatment as Usual | Active comparator | Behavioral: Waitlist Treatment as UsualReceive 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11This 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. | Behavioural | PCIP for youth aged 6 to 11 |
| Waitlist Treatment as UsualWill 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. | Behavioural | Waitlist Treatment as Usual |
Primary outcome
Change in PTSD Knowledge
Time frame: 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
Time frame: 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
Time frame: 1 month
Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.
Intervention Engagement
Time frame: 1 month
Data will be collected regarding participant completion of therapy, no show rates, and attendance.
Intervention Implementation
Time frame: 1 month
Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.
4 secondary outcomes
Change in PTSD and Trauma Symptoms
Time frame: Day 0 baseline, 3 months
Change in Depression Symptoms
Time frame: Day 0 baseline, 3 months
Change in Anxiety Symptoms
Time frame: Day 0 baseline, 3 months
Change in Positive Parenting Practices
Time frame: Day 0 baseline, 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren C Ng, PhD principal investigator
UCLA Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11 and Waitlist Treatment as Usual in people with Post-Traumatic Stress Disorder in Children and Post-traumatic Stress Disorder, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Knowledge (time frame: Day 0 baseline, 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.