Child Maltreatment(BPC)NCT06160050
PRESERVE & CONNECT: Impact Study of the BPC
A study testing Breakthrough Parenting Curriculum: Transforming trauma across generations in people with Child Maltreatment and Trauma, run by University of Vermont at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Child Maltreatment, Trauma
- What is being tested?
- Breakthrough Parenting Curriculum: Transforming trauma across generations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2024to 20 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents involved in, or at risk of involvement in, the child welfare system.
Who cannot join
- active psychosis without medication stabilization
- ongoing major depressive episodes
- active suicidal ideation
- active homicidal ideation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Vermont
Burlington, Vermont, 05401
Jessica Strolin (Goltzman), 8028603173, Jessica.Strolin@uvm.edu
- Recruiting
University of Connecticut
Hartford, Connecticut, 06103
Jon Philips, (959) 200-3600, jon.phillips@uconn.edu
About this study
Official title: Randomized Control Trial of the Breakthrough Parenting Curriculum: Transforming Trauma Across Generations
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.
Read the 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
- Conditions
- Child Maltreatment, Trauma
- Being tested
- Breakthrough Parenting Curriculum: Transforming trauma across generations
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakthrough Parenting Curriculum: Transforming trauma across generationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BPC | Experimental | Not described Receives: Behavioral: Breakthrough Parenting Curriculum: Transforming trauma across generations |
| Treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Safety
substantiated reports of child maltreatment as per administrative records
Measured: up to 6 months
Child Permanency
out of family placements and placement disruptions as per administrative records. Total amount of each type of placement.
Measured: up to 6 months
Child Well-being
behavioral and emotional functioning of their children (Strength and Difficulties Questionnaire).
Measured: 10 weeks
Parenting Self-Efficacy Scale
Scores range from 0-160. Higher scores indicate more self efficacy
Measured: 10 weeks
Secondary outcomes (2)
Parental Stress Index
Parent Stress Index Self-Report Measure
Measured: 10 weeks
Trauma-Informed Knowledge and Parenting Skills Survey
understanding of the influence of trauma on their parenting behaviors and wellness
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Feb 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut
- Responsible party
- Principal investigator, Jessica Strolin-Goltzman, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160050
- Sponsor's protocol ID
- 2648
- Acronym
- (BPC)
- Status last verified
- Apr 2025
- First submitted
- 23 Jun 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of the Breakthrough Parenting Curriculum: Transforming Trauma Across Generations
- ClinicalTrials.gov ID
- NCT06160050
- Acronym / sponsor ID
- (BPC) / 2648
- Conditions
- Child Maltreatment, Trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- University of Connecticut
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BPC | Experimental | Behavioral: Breakthrough Parenting Curriculum: Transforming trauma across generations |
| Treatment as usual | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parents involved in, or at risk of involvement in, the child welfare system.
Key exclusion criteria (4 listed)
- active psychosis without medication stabilization
- ongoing major depressive episodes
- active suicidal ideation
- active homicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakthrough Parenting Curriculum: Transforming trauma across generationsThe 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. | Behavioural | BPC |
Primary outcome
Child Safety
Time frame: up to 6 months
substantiated reports of child maltreatment as per administrative records
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.
Child Well-being
Time frame: 10 weeks
behavioral and emotional functioning of their children (Strength and Difficulties Questionnaire).
Parenting Self-Efficacy Scale
Time frame: 10 weeks
Scores range from 0-160. Higher scores indicate more self efficacy
2 secondary outcomes
Parental Stress Index
Time frame: 10 weeks
Trauma-Informed Knowledge and Parenting Skills Survey
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakthrough Parenting Curriculum: Transforming trauma across generations in people with Child Maltreatment and Trauma, run by University of Vermont at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Safety (time frame: up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.