Relationship, FamilyHMRF-CPNCT03640546
Healthy Marriage and Responsible Fatherhood Grant Program With Phoenix House of New York
An observational study of Relationship, Family and Substance Use, run by Phoenix House Foundation, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to provide a process and outcome evaluation of the HMRF grant-funded Connections program. Phoenix Houses of New York, Inc. has been given a new grant to continue and refine its successful Connections program which equips single and coupled participants with significant substance use… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Relationship, Family, Substance Use, Parenting
- What is being tested?
- Within My Reach/ Within Our Reach
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,825 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 May 2016to 30 Sep 2020
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults in romantic relationships with or without children
Who may be able to join
- Adult Phoenix House clients who are enrolled in Connections evidence-based interventions
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Phoenix House - Hauppauge
Hauppauge, New York, 11788
Genevieve Vaida, MPA
- Recruiting
Phoenix House - Long Island City
Long Island City, New York, 11106
Genevieve Vaida, MPA
- Recruiting
Phoenix House - Ronkonkoma
Ronkonkoma, New York, 11779
Genevieve Vaida, MPA
About this study
Official title: Program Evaluation of Connections, a Healthy Marriage and Responsible Fatherhood (HMRF) Grant Funded Program.
The purpose of this study is to provide a process and outcome evaluation of the HMRF grant-funded Connections program. Phoenix Houses of New York, Inc. has been given a new grant to continue and refine its successful Connections program which equips single and coupled participants with significant substance use disorders (SUD) with the skills and knowledge needed to (1) create and/or sustain healthy relationships/marriages, (2) equip participants with the skills and knowledge to raise children in a functional and healthy environment, (3) improve their financial stability, job readiness and employability to improve economic self-sufficiency and responsibility, and (4) reduce relationship stress and strain on interactions between co-parents.
Read the detailed description
The process evaluation will focus on:
- Documenting project implementations and determining efficient replication methods for effective program components,
- Monitoring completion of overall program goals and objectives, and
- Allow for quality improvement during the five year grant cycle.
The outcome evaluation which focuses on participant level impact will ask the following:
- Does participation in evidence-based relationship education improve healthy relationship skills for single or coupled enrollees?
- Does participation in partner education and support classes improve co-parenting relationship?
- Do participants have better attitudes toward their ability to manage money (i.e. savings, paying bills) after workshops in financial literacy and other money management services?
- Do participants have improved attitudes on their own employability after workshops targeted at job readiness?
- Does participation in job readiness preparation translate into improved employment prospects or readiness factors? (Readiness factors may include increased family assets and economic status.)
- Does participation in family care management sessions improve marriage/relationship, child and family well-being?
- Does participation in parenting education improve parenting skills and attitudes toward parenting? Does participation in parenting education improve commitment to parenting and children?
- Conditions
- Relationship, Family, Substance Use, Parenting
- Being tested
- Within My Reach/ Within Our Reach
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Within My Reach/ Within Our ReachBehavioural
Relationship education workshops
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Healthy Relationship Skills
Evidence-based curriculum scale. Questionnaire Items range on a scale from (1) Strongly Disagree to (5) Strongly Agree. Generally a higher response indicates a better outcome however some items are reverse-coded.
Measured: 0 days, 30 days, and 90 days
Secondary outcomes (2)
Change in co-parenting relationship and attitudes towards parenting
Parenting curriculum scale. Questionnaire Items range on a scale from (1) Strongly Disagree to (4) Strongly Agree. Generally a higher response indicates a better outcome however some items are reverse-coded.
Measured: 0 days and 90 days
Change in job readiness and attitudes towards employability
Vocational Scale. Questions are on a yes or no scale, with yes indicating a better response.
Measured: 0 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start27 May 2016
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relationship, FamilyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,825 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phoenix House Foundation, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- New York University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640546
- Sponsor's protocol ID
- 90FM0110-01-00
- Acronym
- HMRF-CP
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 22 Aug 2018
- 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 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program Evaluation of Connections, a Healthy Marriage and Responsible Fatherhood (HMRF) Grant Funded Program.
- ClinicalTrials.gov ID
- NCT03640546
- Acronym / sponsor ID
- HMRF-CP / 90FM0110-01-00
- Conditions
- Relationship, Family, Substance Use, Parenting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,825 participants (estimated)
- Lead sponsor
- Phoenix House Foundation, Inc.University, hospital or other
- Collaborators
- New York University
- Study start
- 27 May 2016 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 21 Aug 2018 (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 purpose of this study is to provide a process and outcome evaluation of the HMRF grant-funded Connections program. Phoenix Houses of New York, Inc. has been given a new grant to continue and refine its successful Connections program which equips single and coupled participants with significant substance use disorders (SUD) with the skills and knowledge needed to (1) create and/or sustain healthy relationships/marriages, (2) equip participants with the skills and knowledge to raise children in a functional and healthy environment, (3) improve their financial stability, job readiness and employability to improve economic self-sufficiency and responsibility, and (4) reduce relationship stress and strain on interactions between co-parents.
Detailed description
The process evaluation will focus on:
- Documenting project implementations and determining efficient replication methods for effective program components,
- Monitoring completion of overall program goals and objectives, and
- Allow for quality improvement during the five year grant cycle.
The outcome evaluation which focuses on participant level impact will ask the following:
- Does participation in evidence-based relationship education improve healthy relationship skills for single or coupled enrollees?
- Does participation in partner education and support classes improve co-parenting relationship?
- Do participants have better attitudes toward their ability to manage money (i.e. savings, paying bills) after workshops in financial literacy and other money management services?
- Do participants have improved attitudes on their own employability after workshops targeted at job readiness?
- Does participation in job readiness preparation translate into improved employment prospects or readiness factors? (Readiness factors may include increased family assets and economic status.)
- Does participation in family care management sessions improve marriage/relationship, child and family well-being?
- Does participation in parenting education improve parenting skills and attitudes toward parenting? Does participation in parenting education improve commitment to parenting and children?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults in romantic relationships with or without children
Key inclusion criteria (1 listed)
- Adult Phoenix House clients who are enrolled in Connections evidence-based interventions
Key exclusion criteria (1 listed)
- Inability to provide informed consent
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 |
|---|---|---|
| Within My Reach/ Within Our ReachRelationship education workshops | Behavioural | – |
Primary outcome
Change in Healthy Relationship Skills
Time frame: 0 days, 30 days, and 90 days
Evidence-based curriculum scale. Questionnaire Items range on a scale from (1) Strongly Disagree to (5) Strongly Agree. Generally a higher response indicates a better outcome however some items are reverse-coded.
2 secondary outcomes
Change in co-parenting relationship and attitudes towards parenting
Time frame: 0 days and 90 days
Change in job readiness and attitudes towards employability
Time frame: 0 days and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relationship, Family and Substance Use, run by Phoenix House Foundation, Inc. at 3 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 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: status not confirmed, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Genevieve Vaida, MPA (3475333684, gvaida@phoenixhouse.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Healthy Relationship Skills (time frame: 0 days, 30 days, and 90 days). 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 22 Aug 2018.