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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06160050
Other study ID # 2648
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date September 20, 2027

Study information

Verified date December 2023
Source University of Vermont
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 240
Est. completion date September 20, 2027
Est. primary completion date April 30, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Breakthrough Parenting Curriculum: Transforming trauma across generations
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.

Locations

Country Name City State
United States University of Vermont Burlington Vermont

Sponsors (2)

Lead Sponsor Collaborator
University of Vermont University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Child Safety substantiated reports of child maltreatment as per administrative records up to 6 months
Primary Child Permanency out of family placements and placement disruptions as per administrative records. Total amount of each type of placement. up to 6 months
Primary Child Well-being behavioral and emotional functioning of their children (Strength and Difficulties Questionnaire). 10 weeks
Primary Parenting Self-Efficacy Scale Scores range from 0-160. Higher scores indicate more self efficacy 10 weeks
Secondary Parental Stress Index Parent Stress Index Self-Report Measure 10 weeks
Secondary Trauma-Informed Knowledge and Parenting Skills Survey understanding of the influence of trauma on their parenting behaviors and wellness 10 weeks
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