Examining Whether Project Support Works (NCT06963554) | Clinical Trial Compass
RecruitingNot Applicable
Examining Whether Project Support Works
United States100 participantsStarted 2025-11-04
Plain-language summary
This study will involve a randomized, controlled trial with two parallel groups, Project Support and a treatment as usual control group. Families with a child on the waitlist for trauma-focused services will be invited to participate. Participation involves completing a baseline assessment of family functioning and trauma characteristics. Participants will then be randomized to either Project Support or the treatment as usual control group. All participants will be invited to complete the post-test assessment 4-6 weeks after the baseline assessment, prior to beginning trauma-focused services.
Who can participate
Age range
6 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Family is seeking trauma-focused services for their child;
* Child is between 6 - 13 years old;
* Caregiver agreed to be contacted for volunteer research opportunities;
* Caregiver and child can communicate in English or Spanish;
* Child has been living with caregiver for the last 6 months or longer;
* Family is able to participate in services delivered via telehealth.
Exclusion Criteria:
* Child or caregiver has a diagnosis that would impair their ability to participate in or benefit from services (e.g., traumatic brain injury, developmental disability, psychosis);
* Child is in Foster Care or Department of Social Services custody;
* The caregiver is unwilling or unable to give informed consent and/or the child is unwilling and unable to give assent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parenting self-efficacy assessed by the Tool to Measure Parenting Self-Efficacy (TOPSE)
Timeframe: Baseline to Post-test (6 weeks)
2
Supportive parenting assessed by the Parent Behavior Inventory
Timeframe: Baseline to Post-test (6 weeks)
3
Attendance to trauma-focused treatment intake session coded from clinical records