Trauma Clinical Trial - PRESERVE & CONNECT: Impact Study of the BPC

Status Not yet recruiting

Clinical Trial Summary

The PRESERVE & CONNECT project is a multi-site randomized control trial of the Breakthrough Parenting Curriculum: Navigating Trauma Across Generations (BPC) in rural and racially and ethnically diverse communities in Vermont and Connecticut.

Clinical Trial Description

The proposed study will determine the efficacy of the BPC at improving the lives of families with a significant history of trauma and establish the evidence base to allow the BPC to be listed on the Title IV-E Clearing House. The specific research questions that will be answered as are as follows: Question 1: Does the BPC improve Child Safety? Hypothesis 1a: Parents who complete the BPC will have fewer substantiated of child maltreatment as per administrative records. Hypothesis 1b: Parents who complete the BPC will report less psychologically aggressive and abusive parenting behaviors (Parenting Scale). Question 2: Does the BPC improve Child Permanency? Hypothesis 2a: Parents who complete the BPC will have fewer out of family placements and placement disruptions as per administrative records. Hypothesis 2b: Parents who complete the BPC will have stability or permanency with their family of origin as per administrative records. Question 3: Does the BPC improve Child Well-Being? Hypothesis 3: Parents who complete the BPC will report improved behavioral and emotional functioning of their children (Strength and Difficulties Questionnaire). Question 4: Does the BPC improve Adult Well-Being? Hypothesis 4a: Parents who complete the BPC will report improved use of parenting practices to improve the functional relationship with their children (Parenting Self-Efficacy Scale; Parent Stress Index, Parent-Child Relationship Scales). Hypothesis 4b: Parents who complete the BPC will report improved understanding of the influence of trauma on their parenting behaviors and wellness (Trauma-Informed Knowledge and Parenting Skills Survey). Question 5: Are the improvements of the BPC associated with demographic factors? Exploratory Analysis 5a: Examine the association between measures of child safety, child well-being, child permanency, and adult well-being and measures of acculturation. Exploratory Analysis 5a: Examine the association between measures of child safety, child well-being, child permanency, and adult well-being and measures of acculturation ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06160050
Study type	Interventional
Source	University of Vermont
Contact
Status	Not yet recruiting
Phase	N/A
Start date	January 1, 2024
Completion date	September 20, 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04848376` - Post-Market Clinical Follow-up Study of A-SPINE's Products
Terminated	`NCT03781817` - Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures	Phase 4
Completed	`NCT04342416` - Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women	N/A
Recruiting	`NCT04856449` - DBT Skills Plus EMDR for BPD and Trauma	N/A
Completed	`NCT04356963` - Adjunct VR Pain Management in Acute Brain Injury	N/A
Completed	`NCT05669313` - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Active, not recruiting	`NCT03622632` - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Recruiting	`NCT04725721` - Testing FIRST in Youth Outpatient Psychotherapy	N/A
Active, not recruiting	`NCT05530642` - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel	N/A
Not yet recruiting	`NCT05649891` - Checklists Resuscitation Emergency Department	N/A
Not yet recruiting	`NCT03696563` - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS	N/A
Withdrawn	`NCT03249129` - Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Completed	`NCT02240732` - Surgical Tourniquets and Cerebral Emboli	N/A
Completed	`NCT02227979` - Effects of PURPLE Cry Intervention	N/A
Withdrawn	`NCT01169025` - Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients	N/A
Recruiting	`NCT01812941` - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients	N/A
Completed	`NCT03112304` - Child STEPS for Youth Mental Health in Maine Sustainability	N/A
Completed	`NCT01475344` - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)	Phase 1/Phase 2
Completed	`NCT01201863` - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy	Phase 4
Completed	`NCT01210417` - Trauma Heart to Arm Time	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PRESERVE & CONNECT: Impact Study of the BPC — (BPC)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms