Clinical trial NCT06160050: PRESERVE & CONNECT: Impact Study of the BPC
Official title: Randomized Control Trial of the Breakthrough Parenting Curriculum: Transforming Trauma Across Generations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Maltreatment
Trauma
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: University of Connecticut
First posted: 2023-12-07
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Preserve and Connect Project will be a two arm (BPC+ TAU vs TAU) parallel randomized clinical trial to determine the efficacy of the BPC and establish the evidence base to allow the BPC to be listed on the Title IV-E Clearing House. Participants will be recruited from individuals seeking treatment from our community partners.
Primary purpose: PREVENTION

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Child Safety
timeFrame: up to 6 months
measure: Child Permanency
timeFrame: up to 6 months
measure: Child Well-being
timeFrame: 10 weeks
measure: Parenting Self-Efficacy Scale
timeFrame: 10 weeks
Secondary outcomes:
measure: Parental Stress Index
timeFrame: 10 weeks
measure: Trauma-Informed Knowledge and Parenting Skills Survey
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Hartford
country: United States
facility: University of Connecticut
state: Connecticut
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References: