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BehaviorNCT04403451

True North Healthy Relationships Grant

A study testing True North in people with Behavior, run by Children's Harbor, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The scientific purpose of the Children's Harbor True North evaluation study is to use a randomized controlled trial (RCT) to analyze the effects produced by True North and compare the outcomes of the program and comparison groups. The type of research for the RCT impact evaluation is behavioral. Read more about this study

Who is it for?
Ages 17 to 23 yearsHealthy volunteers can take part
Conditions the study is for
Behavior
What is being tested?
True North
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
No sites listed yet
Study dates
1 Oct 2015to 15 May 2020
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 17 to 23 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Young adult age 17 to 23
  • Aging out of the foster care system in Broward County, Florida

Who cannot join

  • Anyone not in foster care

About this study

Official title: True North: Forging Pathways to Healthy Relationships and Economic Stability

The scientific purpose of the Children's Harbor True North evaluation study is to use a randomized controlled trial (RCT) to analyze the effects produced by True North and compare the outcomes of the program and comparison groups. The type of research for the RCT impact evaluation is behavioral.

The goal of the True North grant program is to successfully guide young adults who are randomly assigned to the program group through the transition from the foster care system to adulthood. The objectives of the True North program are to: 1) offer targeted, evidence-based healthy relationship interventions to the program group; 2) offer financial literacy to the program group in order for the participants to achieve greater economic stability; 3) provide job readiness sessions and connect the program group to subsidized and unsubsidized employment opportunities; and 4) match the young adults in the program group with a mentor to provide a permanent connection for guidance with relationship and financial issues.

The overall hypothesis is that participation in the True North program will increase the likelihood that the young adults will improve their relationships, improve their financial and employment stability, and improve their wellbeing.

Read the detailed description

The investigator will use an experimental design using a randomized controlled trial for the impact evaluation of the True North program. This is a sound methodological design to assess the outcomes of the participants in the program and comparison groups. The target population is at-risk youth age 17 to 23 who have been involved in the foster care system and are preparing to "transition into adulthood." The units of analysis are young adults in the foster care system. The investigator plans to have 80-120 research study participants in each of the 3 cohorts. Over the 5-year grant period, a total of 300-360 young adults will be in the sample, with approximately 150-165 young adults in the program group and approximately 150-165 young adults in the comparison group. The inclusion criterion is: Any young adult age 17 to 23 who is aging out of the foster care system. The exclusion criterion does include an age restriction of 18 to 23 because that is the age group that receives extended foster care services in Broward County. Services end at age 24. There are no gender-based enrollment restrictions. There are no race-based enrollment restrictions.

The young adults randomly assigned to the program groups will take part in a multi-component intervention consisting of group workshops and individual sessions on relationship skills and financial stability and receive employment assistance and mentoring. For the healthy relationships component, program participants could receive 13 hours of workshops and 7 hours of individual sessions. For the economic stability component, program participants could receive 3.5 hours of financial stability and job readiness workshops and 7 hours of individual sessions about finance and employment. For the mentoring component, program participants could receive up to 7 hours of case management and 10 hours of prosocial events. All sessions will take place at the Children's Harbor Lauderhill office over a 9-month period.

The young adults in the program group will be completing a pre-test, post-test, and a followup. Answering the pre- and post-tests will take about 1 hour each and will be conducted at the Children's Harbor office, on the phone, or online. Participation in this evaluation study will take a total of approximately 106-112 hours of their time during the year-long program.

The investigator expects the True North program group to have improved relationship skills because of the participation in the Love Notes and mentoring components of the True North program. Love Notes v2.0, which was adapted from Relationships Smarts Plus, an evidence-based intervention rated by SAMSHA's National Registry of Evidence-based Programs and Practices (NREPP), will be utilized to help participants develop healthy relationship skills. It was selected based on its proven track record in serving diverse, economically disadvantaged youth and young adults age 16 to 24 who are at risk for poor quality relationships and unplanned pregnancies (NREPP 2012). An evaluation of Love Notes for Youth Build USA found that Love Notes participants improved their attitudes, knowledge, perceived skills, and behaviors associated with healthy relationships. When compared to with the control group, the Love Notes group had higher post program scores about their knowledge of healthy relationships.

The investigator expects True North participants to become financially stable through debt reduction, increased savings, improved credit scores, and asset building. The Annie E. Casey Foundation has developed a promising a practice of providing a coordinated set of services to help low-income individuals and families get jobs, strengthen their finances and move up the economic ladder. This practice entitled, Working Families Success Network (previously entitled the Center for Working Families), will be utilized to help participants develop financial literacy and job readiness skills. The Annie E. Casey Foundation reports that the Working Families Success Network model, which has been adopted at more than 100 locations throughout the country, has resulted in 4,400 people finding jobs, 3,300 getting steady 30-day employment, 2,300 obtaining public benefits, 2,800 improving their net worth, and 2,700 improving their credit score. Program participants also were five times more likely to achieve a major economic outcome - such as buying a car, getting out of debt or completing a training or education program - than the participants' counterparts who did not receive an intensive, coordinated set of services.

The True North program will support the development of job readiness skills, explore the participants' career interests, connect them to subsidized and unsubsidized job opportunities, and job coaching. The employment component will be supported by the True North Program Coordinator, Financial Coach, and Navigator. The Program Coordinator is developing relationships with employers to encourage and support job placement for participants. In addition, the Program Coordinator is working on implementing subsidized part time employment opportunities in the nonprofit arena. Participants will be prepared for these job opportunities by attending job readiness and career exploration sessions included in the financial literacy curriculum. The Financial Coach will also provide one-on-one job coaching as well as information on wages, benefits, and taxes. Most importantly, the participant's Navigator will guide the participants through a job hunt, provide support during the application and hiring process, and assist with job transitions.

Conditions
Behavior
Being tested
True North
Keywords
Relationships
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • True NorthBehavioural

    Love Notes, Financial Stability, Jobs

Study groups in NCT04403451
Study groupRoleWhat they receive
Phase 1/Cohort 1ExperimentalTrue North Love Notes, Financial Stability, Jobs
Receives: Behavioral: True North
Phase 2/Cohort 2ExperimentalTrue North Love Notes, Financial Stability, Jobs
Receives: Behavioral: True North
Phase 3/Cohort 3ExperimentalTrue North Love Notes, Financial Stability, Jobs
Receives: Behavioral: True North

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Healthy relationship measure from the Administration for Children and Families (ACF) Healthy Marriages post-program survey: "In a healthy relationship, it is essential for couples to talk about things that are important to them."

    4-point agreement scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree), Higher score indicates better outcome.

    Measured: Immediately after the intervention

  2. Healthy relationship measure from the ACF Healthy Marriages post-program survey: "Even in a good relationship, couples will occasionally have trouble talking about their feelings."

    4-point agreement scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree), Higher score indicates better outcome.

    Measured: Immediately after the intervention

  3. Healthy relationship measure from the ACF Healthy Marriages post-program survey: "A relationship is stronger if a couple doesn't talk about their problems."

    4-point agreement scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree), Lower score indicates better outcome.

    Measured: Immediately after the intervention

  4. Job readiness measure from the ACF post-program survey: "You know where to find job openings."

    4-point agreement scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree), Higher score indicates better outcome.

    Measured: Immediately after the intervention

  5. Job readiness measure from the ACF post-program survey: "You feel confident in your ability to conduct an effective job search for the job you want."

    4-point agreement scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree), Higher score indicates better outcome.

    Measured: Immediately after the intervention

  6. Job readiness measure from the ACF post-program survey: "You know how to apply for a job."

    4-point agreement scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree), Higher score indicates better outcome.

    Measured: Immediately after the intervention

  7. Job readiness measure from the ACF post-program survey: "You feel confident about your interviewing skills."

    4-point agreement scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree), Higher score indicates better outcome.

    Measured: Immediately after the intervention

  8. Financial assistance measure from the ACF follow-up survey: "Do you currently have enough income to cover regular expenses?"

    0=No, 1=Yes, Higher score indicates better outcome

    Measured: Up to 24 weeks

  9. Financial assistance measure from the ACF follow-up survey: "Do you currently have a checking account that you use?"

    0=No, 1=Yes, Higher score indicates better outcome

    Measured: Up to 24 weeks

  10. Financial assistance measure from the ACF follow-up survey: "Do you currently have a savings account?"

    0=No, 1=Yes, Higher score indicates better outcome

    Measured: Up to 24 weeks

  11. Financial assistance measure from the ACF follow-up survey: "Do you currently have money saved for an emergency?"

    0=No, 1=Yes, Higher score indicates better outcome

    Measured: Up to 24 weeks

  12. Life Satisfaction measure from National Accounts Measure of Well-being: "How satisfied are you with your life overall?"

    4-point satisfaction scale (1=very dissatisfied, 2=dissatisfied, 3=satisfied, 4=very satisfied), Higher score indicates a better outcome

    Measured: Up to 24 weeks

Secondary outcomes (14)
  1. Relationship violence measure from the ACF Healthy Marriages post-program survey: "In a healthy relationship, how important is it that couples do not call each other names?"

    4-point importance scale (1=not at all important, 2=a little important, 3=pretty important, 4=very important), Higher score indicates better outcome.

    Measured: Immediately after the intervention

  2. Relationship violence measure from the ACF Healthy Marriages post-program survey: "In a healthy relationship, how important is it that couples do not threaten each other?"

    4-point importance scale (1=not at all important, 2=a little important, 3=pretty important, 4=very important), Higher score indicates better outcome.

    Measured: Immediately after the intervention

  3. Relationship violence measure from the ACF Healthy Marriages post-program survey: "In a healthy relationship, how important is it that couples do not push, shove, hit, slap or grab each other?"

    4-point importance scale (1=not at all important, 2=a little important, 3=pretty important, 4=very important), Higher score indicates better outcome.

    Measured: Immediately after the intervention

  4. Partner relationship measure from the ACF Healthy Marriages post-program survey: "How often do the following things happen with your partner/significant other - My partner can count on me to be there when he/she needs me."

    5-point scale (1=none of the time, 2=some of the time, 3=half of the time, 4=most of the time, 5= all of the time), Higher score indicates better outcome.

    Measured: Immediately after the intervention

  5. Partner relationship measure from the ACF Healthy Marriages post-program survey: "How often do the following things happen with your partner/significant other - My partner and I talk about things that really matter."

    5-point scale (1=none of the time, 2=some of the time, 3=half of the time, 4=most of the time, 5= all of the time), Higher score indicates better outcome.

    Measured: Immediately after the intervention

  6. Partner relationship measure from the ACF Healthy Marriages post-program survey: "How often do the following things happen with your partner/significant other - I am comfortable sharing my thoughts and feelings with my partner."

    5-point scale (1=none of the time, 2=some of the time, 3=half of the time, 4=most of the time, 5= all of the time), Higher score indicates better outcome.

    Measured: Immediately after the intervention

  7. Employment measure from the ACF post-program survey: "How much does each of the following make it hard for you to find or keep a job? - Do not have reliable transportation."

    3-point scale (1=never, 2=sometimes, 3=always), Lower score indicates better outcome

    Measured: Immediately after the intervention

  8. Employment measure from the ACF post-program survey: "How much does each of the following make it hard for you to find or keep a job? - Do not have the right clothes."

    3-point scale (1=never, 2=sometimes, 3=always), Lower score indicates better outcome

    Measured: Immediately after the intervention

  9. Employment measure from the ACF post-program survey: "How much does each of the following make it hard for you to find or keep a job? - Do not have documentation for legal employment."

    3-point scale (1=never, 2=sometimes, 3=always), Lower score indicates better outcome

    Measured: Immediately after the intervention

  10. Employment measure from the ACF post-program survey: "How much does each of the following make it hard for you to find or keep a job? - Do not have good enough child care."

    3-point scale (1=never, 2=sometimes, 3=always), Lower score indicates better outcome

    Measured: Immediately after the intervention

  11. Employment measure from the ACF post-program survey: "How much does each of the following make it hard for you to find or keep a job? - Have criminal record."

    3-point scale (1=never, 2=sometimes, 3=always), Lower score indicates better outcome

    Measured: Immediately after the intervention

  12. Employment measure from the ACF post-program survey: "How much does each of the following make it hard for you to find or keep a job? - Do not have the education for good jobs."

    3-point scale (1=never, 2=sometimes, 3=always), Lower score indicates better outcome

    Measured: Immediately after the intervention

  13. Employment measure from the ACF post-program survey: "How much does each of the following make it hard for you to find or keep a job? - Have substance abuse problem."

    3-point scale (1=never, 2=sometimes, 3=always), Lower score indicates better outcome

    Measured: Immediately after the intervention

  14. Employment measure from the ACF post-program survey: "How much does each of the following make it hard for you to find or keep a job? - Have mental health problem."

    3-point scale (1=never, 2=sometimes, 3=always), Lower score indicates better outcome

    Measured: Immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2020
  2. Study start1 Oct 2015
  3. Primary completion15 May 2020
  4. Study completion15 May 2020

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Experimental design with a randomized controlled trial for the impact evaluation.
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04403451
Sponsor's protocol ID
90FM006902
Status last verified
May 2020
First submitted
18 Jul 2017
Last updated
27 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing True North in people with Behavior, run by Children's Harbor, Inc..

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 2 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 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Healthy relationship measure from the Administration for Children and Families (ACF) Healthy Marriages post-program survey: "In a healthy relationship, it is essential for couples to talk about things that are important to them." (time frame: Immediately after the intervention). The study lists 12 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 27 May 2020.

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