ParentingFRAMEWorksNCT05367102
Supporting Healthy Relationships Program for FRAMEWorks (SHR FRAMEWorks)
A study testing Supporting Healthy Relationships program in people with Parenting and Family Relations, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The overarching objective for the Supporting Health Relationships (SHR) program is to create and sustain families in the Bronx by improving relationship skills, improving parenting skills, and improving parental financial support for children. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Family Relations, Relationship, Family
- What is being tested?
- Supporting Healthy Relationships program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,022 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Married or unmarried couples who are 18 years or older
- Must have custodial children (biological, foster, adopted) under the age of 18 (or expectant parents)
- Income below 200% of poverty level
Who cannot join
- Active intimate partner violence and increased risk of intimate partner violence
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10451
About this study
Official title: Montefiore Medical Center Supporting Healthy Relationships Program for FRAMEWorks
The overarching objective for the Supporting Health Relationships (SHR) program is to create and sustain families in the Bronx by improving relationship skills, improving parenting skills, and improving parental financial support for children. The investigator's local evaluation addresses a research question about the effectiveness of delivering the SHR curriculum virtually: To what extent do couples show improvements in engagement, skills learning, and relationship quality outcomes when receiving the curriculum over Zoom?
Read the detailed description
More specifically, the investigator is interested in answering the following research questions:
Primary Study Question:
- To what extent do clients show increased relationship satisfaction (Primary Endpoint: Couples Satisfaction Index-CSI) after receiving the virtual Zoom relationship education intervention?
- To what extent do partner effects impact this outcome? Secondary Study Questions:
- To what extent do clients learn and retain the knowledge and skills that are taught in the relationship education intervention?
- To what extent do partner effects impact this outcome?
- To what extent do clients become more emotionally intelligent after the relationship education intervention?
- To what extent do partner effects impact this outcome?
- To what extent do clients show improved co-parenting relationships after the relationship education intervention?
- To what extent do partner effects impact this outcome?
- To what extent do clients become more securely attached to their partners after receiving the relationship education intervention?
- To what extent do partner effects impact this outcome?
- To what extent do clients attend workshops when they are delivered virtually via Zoom?
- To what extent do partner effects impact this outcome?
- To what extent are clients engaged in workshops when they are delivered virtually via Zoom? a) To what extent do partner effects impact this outcome?
NOTE: The Post-Randomization Phase of the study begins on 01/01/2025. Participants will no longer be randomized to one of the two study arms during this phase. Additionally, data collection at the 6-month follow-up point will not occur during this phase. Participants will now have the autonomy to choose their preferred mode of participation, either in virtual or in-person workshops. This choice aims to provide greater flexibility and accommodate participants' preferences while continuing to deliver the same curriculum. Both arms will maintain identical workshop content, facilitation quality, and support services to ensure consistency across delivery modes. The shift to a non-randomized structure in this phase reflects the conclusion of the initial randomized trial while enabling ongoing access to the program for participants under a more participant-centered delivery model. This approach will allow researchers to observe participation trends and engagement levels under conditions of self-selection, complementing the insights gained from the randomized control trial.
- Conditions
- Parenting, Family Relations, Relationship, Family
- Being tested
- Supporting Healthy Relationships program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supporting Healthy Relationships programBehavioural
The investigator will provide the following 4 activities: 1) marriage and relationship education [using a modified version of the empirically supported Loving Couples, Loving Children (LCLC); 2) pre-marital education and marriage skills; 3) marriage enhancement and marriage skills for married couples; and 4) divorce reduction and relationship skills.
All couples will be expected to participate in 24 hours of core relationship education workshops (including parenting education). Since parental financial support represents a core element of family stability, relationship education workshops will address motivation for providing financial support through employment for all couples (employed and unemployed) as well as how to manage conflicts over money. All couples will be invited to supplemental workshops (with couples from other cohorts) on topics of specialized interest, including employment services and financial literacy (i.e. budgeting, debt, etc.)
| Study group | Role | What they receive |
|---|---|---|
| In Person | Experimental | Participants will receive all services in person, including participating in the initial intake process, and attending all workshops. Receives: Behavioral: Supporting Healthy Relationships program |
| Virtual (Zoom) | Experimental | Participants will complete their intake process in person, but will complete all workshops virtually through Zoom. Receives: Behavioral: Supporting Healthy Relationships program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Relationship Satisfaction at 6 months
Relationship satisfaction is assessed using the Couples Satisfaction Index-32 (Funk \& Rogge, 2007): Considered the gold standard, this measure detects differences in relationship satisfaction with great precision. This outcome measure is a scale (value 0 to 5 and 6 for one item, ranging from never; extremely bad; extremely unhappy; not at all true; always disagree, to more often; extremely good; perfect; completely true; always agree), calculated by summing the responses across all of the items. Scores can range from 0 to 161. Higher scores indicate higher levels of relationship satisfaction and scores falling below 104.5 suggest notable relationship dissatisfaction. This measure has demonstrated excellent internal consistency, convergent validity, and construct validity.
Measured: Baseline and 6 month follow up
Secondary outcomes (8)
Information, Family Outcomes, Reporting, and Management (nFORM) Applicant Characteristics
This is a survey developed by the Office of Family Assistance utilized by all grantees participating in the national study, that gathers demographic information regarding participants.
Measured: Baseline
Information, Family Outcomes, Reporting, and Management (nFORM) Pre-Program Survey
This is a survey developed by the Office of Family Assistance utilized by all grantees participating in the national study that includes questions regarding relationship satisfaction, financial stability, and parenting
Measured: At start of intervention (Week 1 of 12)
Information, Family Outcomes, Reporting, and Management (nFORM) Post-Program Survey
This is a survey developed by the Office of Family Assistance utilized by all grantees participating in the national study that includes questions regarding relationship satisfaction, financial stability, and parenting.
Measured: Immediately post intervention (Week 12 of 12 weeks)
Assessing Emotions Scale (Emotion Intelligence)
Emotional intelligence is assessed using the Assessing Emotions Scale (Schutte, et al., 1998). This outcome measure is a 33-item measure of emotional intelligence that uses a Likert scale of measurement (value 1 - 5, ranging from strongly disagree to strongly agree), calculated by summing the responses across all items. Higher scores indicate higher levels of emotional intelligence. For men, scores below 109 indicate low emotional intelligence; scores between 109 and 131 indicate average emotional intelligence; and scores above 131 indicate high emotional intelligence. For women, scores below 116 indicate low emotional intelligence; scores between 116 and 145 indicate average emotional intelligence; and scores above 145 indicate high emotional intelligence. This measure has demonstrated good internal consistency, test-retest reliability, and convergent validity.
Measured: Changes from Baseline Emotion Intelligence at 6 month follow up
Parenting Alliance Inventory (Quality of Co-Parenting Relationship)
Parenting Alliance Inventory (Abidin \& Brunner, 1995), is a self-report instrument that assesses the degree to which parents believe that they have a sound working relationship with their child's other parent using a 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). All items are averaged to create a global parenting alliance score. Higher scores indicate a stronger parenting alliance. Used in PACT study. This measure demonstrated excellent internal consistency and good construct and concurrent validity.
Measured: Changes from Baseline Quality of Co-Parenting Relationship at 6 month follow up
The Experiences in Close Relationships - Relationship Structures Questionnaire (ECR-RS) (Adult Attachment Patterns)
Adult attachment is assessed using the Experiences in Close Relationships - Relationship Structures Questionnaire (ECR-RS) (Fraley, et al., 2011). This outcome measure is a 9-item measure that can be used to assess attachment styles with respect to 4 targets (i.e., mother, father, romantic partner, and best friend). We intend to assess mother, father, and romantic partner attachments at baseline and then only romantic partner attachment at follow-up to assess change in adult attachment. This scale uses a Likert scale of measurement (7-point scale where 1 = strongly disagree and 7 = strongly agree) and calculated by averaging certain items together to form specific domains (attachment-related anxiety, attachment-related avoidance, and global attachment). This measure has demonstrated excellent internal consistency, test-retest reliability, and criterion validity.
Measured: Changes from Baseline Adult Attachment Patterns at 6 month follow up
Skills Assessment (Skills Acquisition)
Skill acquisition is assessed using the Skills Assessment. This outcome measure is a 14 item, multiple choice, homegrown assessment to determine whether couples learned skills and techniques taught at workshops. There are two versions of this measure, A and B. This measure is calculated by obtaining the percentage of correctly-scored items. Higher scores indicate greater skill acquisition. Given that this is a homegrown measure, to validate this measure, we will correlate the skill assessment scores with the well validated Assessing Emotions Scale, and assess whether relationship skill scores differ by key demographic and social economic factors.
Measured: Change from Baseline Skills at immediately post intervention and at 6 months
Childhood Trauma Questionnaire-Short Form (CTQ-SF) (Childhood Trauma)
Childhood trauma is assessed using the Childhood Trauma Questionnaire-Short Form (CTQ-SF, Bernstein, et al., 2003). The CTQ is a 28-item measure of childhood trauma that uses a Likert scale of measurement ranging from 1 (never true) to 5 (very often true). Items are divided into 5 sub-categories: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect. This measure is calculated by summing most responses and reverse scoring select items and has demonstrated good test-retest reliability, criterion-related validity, and internal consistency.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Apr 2021
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigator will run workshops virtually, through Zoom, and in person. Participants will be randomized either to the virtual condition, or to the in person condition. Note that effective 1/1/2025, participants will no longer be randomized to one of the two study arms. See 'Detailed Description.'
- Masking
- None (open label)
- Enrolment
- 1,022 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families
- Responsible party
- Sponsor
- Investigators
- Scott Wetzler, PhD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367102
- Sponsor's protocol ID
- 2021-12751
- Other IDs
- 90ZB0022
- Acronym
- FRAMEWorks
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montefiore Medical Center Supporting Healthy Relationships Program for FRAMEWorks
- ClinicalTrials.gov ID
- NCT05367102
- Acronym / sponsor ID
- FRAMEWorks / 2021-12751
- Conditions
- Parenting, Family Relations, Relationship, Family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,022 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 10 May 2022 (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 overarching objective for the Supporting Health Relationships (SHR) program is to create and sustain families in the Bronx by improving relationship skills, improving parenting skills, and improving parental financial support for children. The investigator's local evaluation addresses a research question about the effectiveness of delivering the SHR curriculum virtually: To what extent do couples show improvements in engagement, skills learning, and relationship quality outcomes when receiving the curriculum over Zoom?
Detailed description
More specifically, the investigator is interested in answering the following research questions:
Primary Study Question:
- To what extent do clients show increased relationship satisfaction (Primary Endpoint: Couples Satisfaction Index-CSI) after receiving the virtual Zoom relationship education intervention?
- To what extent do partner effects impact this outcome? Secondary Study Questions:
- To what extent do clients learn and retain the knowledge and skills that are taught in the relationship education intervention?
- To what extent do partner effects impact this outcome?
- To what extent do clients become more emotionally intelligent after the relationship education intervention?
- To what extent do partner effects impact this outcome?
- To what extent do clients show improved co-parenting relationships after the relationship education intervention?
- To what extent do partner effects impact this outcome?
- To what extent do clients become more securely attached to their partners after receiving the relationship education intervention?
- To what extent do partner effects impact this outcome?
- To what extent do clients attend workshops when they are delivered virtually via Zoom?
- To what extent do partner effects impact this outcome?
- To what extent are clients engaged in workshops when they are delivered virtually via Zoom? a) To what extent do partner effects impact this outcome?
NOTE: The Post-Randomization Phase of the study begins on 01/01/2025. Participants will no longer be randomized to one of the two study arms during this phase. Additionally, data collection at the 6-month follow-up point will not occur during this phase. Participants will now have the autonomy to choose their preferred mode of participation, either in virtual or in-person workshops. This choice aims to provide greater flexibility and accommodate participants' preferences while continuing to deliver the same curriculum. Both arms will maintain identical workshop content, facilitation quality, and support services to ensure consistency across delivery modes. The shift to a non-randomized structure in this phase reflects the conclusion of the initial randomized trial while enabling ongoing access to the program for participants under a more participant-centered delivery model. This approach will allow researchers to observe participation trends and engagement levels under conditions of self-selection, complementing the insights gained from the randomized control trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigator will run workshops virtually, through Zoom, and in person. Participants will be randomized either to the virtual condition, or to the in person condition. Note that effective 1/1/2025, participants will no longer be randomized to one of the two study arms. See 'Detailed Description.'
| Arm | Type | Receives |
|---|---|---|
| In Person | Experimental | Behavioral: Supporting Healthy Relationships programParticipants will receive all services in person, including participating in the initial intake process, and attending all workshops. |
| Virtual (Zoom) | Experimental | Behavioral: Supporting Healthy Relationships programParticipants will complete their intake process in person, but will complete all workshops virtually through Zoom. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Married or unmarried couples who are 18 years or older
- Must have custodial children (biological, foster, adopted) under the age of 18 (or expectant parents)
- Income below 200% of poverty level
Key exclusion criteria (1 listed)
- Active intimate partner violence and increased risk of intimate partner violence
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 |
|---|---|---|
| Supporting Healthy Relationships programThe investigator will provide the following 4 activities: 1) marriage and relationship education [using a modified version of the empirically supported Loving Couples, Loving Children (LCLC); 2) pre-marital education and marriage skills; 3) marriage enhancement and marriage skills for married couples; and 4) divorce reduction and relationship skills. All couples will be expected to participate in 24 hours of core relationship education workshops (including parenting education). Since parental financial support represents a core element of family stability, relationship education workshops will address motivation for providing financial support through employment for all couples (employed and unemployed) as well as how to manage conflicts over money. All couples will be invited to supplemental workshops (with couples from other cohorts) on topics of specialized interest, including employment services and financial literacy (i.e. budgeting, debt, etc.) | Behavioural | In Person, Virtual (Zoom) |
Primary outcome
Change in Relationship Satisfaction at 6 months
Time frame: Baseline and 6 month follow up
Relationship satisfaction is assessed using the Couples Satisfaction Index-32 (Funk \& Rogge, 2007): Considered the gold standard, this measure detects differences in relationship satisfaction with great precision. This outcome measure is a scale (value 0 to 5 and 6 for one item, ranging from never; extremely bad; extremely unhappy; not at all true; always disagree, to more often; extremely good; perfect; completely true; always agree), calculated by summing the responses across all of the items. Scores can range from 0 to 161. Higher scores indicate higher levels of relationship satisfaction and scores falling below 104.5 suggest notable relationship dissatisfaction. This measure has demonstrated excellent internal consistency, convergent validity, and construct validity.
8 secondary outcomes
Information, Family Outcomes, Reporting, and Management (nFORM) Applicant Characteristics
Time frame: Baseline
Information, Family Outcomes, Reporting, and Management (nFORM) Pre-Program Survey
Time frame: At start of intervention (Week 1 of 12)
Information, Family Outcomes, Reporting, and Management (nFORM) Post-Program Survey
Time frame: Immediately post intervention (Week 12 of 12 weeks)
Assessing Emotions Scale (Emotion Intelligence)
Time frame: Changes from Baseline Emotion Intelligence at 6 month follow up
Parenting Alliance Inventory (Quality of Co-Parenting Relationship)
Time frame: Changes from Baseline Quality of Co-Parenting Relationship at 6 month follow up
The Experiences in Close Relationships - Relationship Structures Questionnaire (ECR-RS) (Adult Attachment Patterns)
Time frame: Changes from Baseline Adult Attachment Patterns at 6 month follow up
Skills Assessment (Skills Acquisition)
Time frame: Change from Baseline Skills at immediately post intervention and at 6 months
Childhood Trauma Questionnaire-Short Form (CTQ-SF) (Childhood Trauma)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Scott Wetzler, PhD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supporting Healthy Relationships program in people with Parenting and Family Relations, run by Montefiore Medical Center at 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Relationship Satisfaction at 6 months (time frame: Baseline and 6 month follow up). 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 13 Apr 2026.