NCT06160050

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Feb 2024Sep 2027

First Submitted

Initial submission to the registry

June 23, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2027

Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

3.2 years

First QC Date

June 23, 2023

Last Update Submit

April 14, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Child Safety

    substantiated reports of child maltreatment as per administrative records

    up to 6 months

  • Child Permanency

    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

    behavioral and emotional functioning of their children (Strength and Difficulties Questionnaire).

    10 weeks

  • Parenting Self-Efficacy Scale

    Scores range from 0-160. Higher scores indicate more self efficacy

    10 weeks

Secondary Outcomes (2)

  • Parental Stress Index

    10 weeks

  • Trauma-Informed Knowledge and Parenting Skills Survey

    10 weeks

Study Arms (2)

BPC

EXPERIMENTAL
Behavioral: Breakthrough Parenting Curriculum: Transforming trauma across generations

Treatment as usual

NO INTERVENTION

Interventions

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.

BPC

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Parents involved in, or at risk of involvement in, the child welfare system.

You may not qualify if:

  • active psychosis without medication stabilization
  • ongoing major depressive episodes
  • active suicidal ideation
  • active homicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Connecticut

Hartford, Connecticut, 06103, United States

RECRUITING

University of Vermont

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 23, 2023

First Posted

December 7, 2023

Study Start

February 1, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

September 20, 2027

Last Updated

April 17, 2025

Record last verified: 2025-04

Locations