- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06160050
PRESERVE & CONNECT: Impact Study of the BPC ((BPC))
Randomized Control Trial of the Breakthrough Parenting Curriculum: Transforming Trauma Across Generations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06103
- Recruiting
- University of Connecticut
-
Contact:
- Jon Philips
- Phone Number: (959) 200-3600
- Email: jon.phillips@uconn.edu
-
-
Vermont
-
Burlington, Vermont, United States, 05401
- Recruiting
- University of Vermont
-
Contact:
- Jessica Strolin (Goltzman)
- Phone Number: 8028603173
- Email: Jessica.Strolin@uvm.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parents involved in, or at risk of involvement in, the child welfare system.
Exclusion Criteria:
- active psychosis without medication stabilization
- ongoing major depressive episodes
- active suicidal ideation
- active homicidal ideation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Treatment as usual
|
|
|
Experimental: BPC
|
The BPC (Breakthrough Parent Curriculum): Navigating Trauma Across Generations is a 10 module course adapted from the NCTSN training called Caring for Children Who Have Experienced Trauma: A Workshop for Resource Parents (RPC).
The BPC is specifically designed for parents who have been involved with (or are at risk for being involved with)the child welfare system.
The course provides information about the impact of trauma on the development, attachment, emotions and behaviors of children while holding space for parents to learn together about concrete strategies for managing daily and ongoing challenges and enhancing their relationships with their children.
All while acknowledging the challenges of parenting a child who has experienced trauma, while having experienced your own trauma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Safety
Time Frame: up to 6 months
|
substantiated reports of child maltreatment as per administrative records
|
up to 6 months
|
|
Child Permanency
Time Frame: up to 6 months
|
out of family placements and placement disruptions as per administrative records.
Total amount of each type of placement.
|
up to 6 months
|
|
Child Well-being
Time Frame: 10 weeks
|
behavioral and emotional functioning of their children (Strength and Difficulties Questionnaire).
|
10 weeks
|
|
Parenting Self-Efficacy Scale
Time Frame: 10 weeks
|
Scores range from 0-160.
Higher scores indicate more self efficacy
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Stress Index
Time Frame: 10 weeks
|
Parent Stress Index Self-Report Measure
|
10 weeks
|
|
Trauma-Informed Knowledge and Parenting Skills Survey
Time Frame: 10 weeks
|
understanding of the influence of trauma on their parenting behaviors and wellness
|
10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2648
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma
-
Humacyte, Inc.CompletedTrauma | Trauma Injury | Trauma, Multiple | Trauma BluntUkraine
-
Wonju Severance Christian HospitalNational Research Foundation of KoreaCompletedTrauma Injury | Trauma, MultipleKorea, Republic of
-
Arrowhead Regional Medical CenterCompletedTrauma Injury | Trauma Blunt | Vascular TraumaUnited States
-
Prof. Dr. Cemil Tascıoglu Education and Research...CompletedTrauma Injury | Trauma, MultipleTurkey
-
University Hospital, AngersRecruiting
-
Rabin Medical CenterIsraeli Ministry of SecurityUnknown
-
Hospital Departamental de VillavicencioCooperative University of Colombia; Clínica PrimaveraRecruitingTrauma Injury | Trauma Patients in ICU | Trauma (Including Fractures) | Trauma Patients | Trauma ICU PatientsColombia
-
Oslo University HospitalUniversity of Oslo; Sunnaas Rehabilitation Hospital; South-Eastern Norway Regional...RecruitingTrauma Injury | Trauma, Multiple | PolytraumaNorway
-
Chang, Steve S., M.D.Santa Barbara Cottage Hospital; Accumetrics, Inc.CompletedHead Injury Trauma BluntUnited States
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin; Francophone Pediatric Resuscitation...Completed