Economic ProblemsNCT03736590
Clinic-Based Financial Coaching and Family Health and Development
A study testing Financial coaching and services in people with Economic Problems and Development, Child, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will examine the impact of clinic-based financial coaching on parent health-related quality of life and child development measures, as well as family social needs for families with young children receiving pediatric care at a primary care practice in the Los Angeles County safety net. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Economic Problems, Development, Child, Quality of Life
- What is being tested?
- Financial coaching and services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2018to 31 Jul 2030
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents/caregivers in families with children 4 months or under at enrollment receiving care at Harbor-UCLA medical center clinic.
Who cannot join
- Cognitive impairment or not speaking English or Spanish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Clinic-Based Financial Coaching on Health and Development
This study will examine the impact of clinic-based financial coaching on parent health-related quality of life and child development measures, as well as family social needs for families with young children receiving pediatric care at a primary care practice in the Los Angeles County safety net.
Read the detailed description
With an expert group of researchers, financial coaches, and implementation scientists, we will study the impact of clinic-based financial coaching on parent health-related quality of life, child developmental risk, and social needs.We will conduct a clinical randomized controlled trial of financial coaching for low-income families. Parents of infants in a large pediatric primary care safety-net clinic will receive either 1) financial coaching from trained coaches plus social needs screening and resource navigation at all well child visits (intervention) or 2) social needs screening and navigation alone (active control) and will be followed for five years. Aims include:
1a) Examine parent outcomes of overall health-related quality of life (primary parent outcome);
1b) Examine child outcomes of developmental risk scores (primary child outcome) and well-child visit adherence;
1c) Examine family social needs outcomes, including incidence of any food insecurity, housing instability, transportation or utilities interruptions (primary family outcome any one or more) and resource use; and financial metrics.
- Conditions
- Economic Problems, Development, Child, Quality of Life
- Being tested
- Financial coaching and services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial coaching and servicesBehavioural
The intervention will consist of clinic-based financial coaching that focuses on improving financial stability through longitudinal visits with financial services professionals to address financial goals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Financial Coaching Plus Social Needs Screening | Experimental | Families in this intervention arm will receive financial coaching at each well child visit, in addition to clinic-based social needs screening and referral. Receives: Behavioral: Financial coaching and services |
| Control - Social Needs Screening and Referral | Active comparator | Families in this active control arm will receive social needs screening and referral to community resources to address identified social needs. Receives: Behavioral: Financial coaching and services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life (HRQOL) - Patient Reported Outcome Measurement Information System Global Health Short Form 10-Item Scale (PROMIS-10)
Health-related quality of life will be measured at baseline and regular intervals using the Patient-Reported Outcomes Measurement Information System Global Health Short Form 10 (PROMIS 10). This will be the primary outcome for parents in the study. The PROMIS-10 measures overall health, physical health, mental health and social functioning and is scored on a T-scored range with 50 as the mean and 10 as the standard deviation. Higher scores indicate better HRQOL.
Measured: Interval change in PROMIS-10 HRQOL will be assessed over up to a 5 year period.
Developmental Risk - Ages and Stages Questionnaires
Parent report of child developmental risk via clinic-based developmental questionnaires (Ages and Stages Questionnaires, ASQ) will be used to measure developmental risk. The ASQ measure contains sub-scales for each developmental domain (gross motor, fine motor, problem solving, communication, problem-solving, personal-social). Parent-reported ASQ items yield a score from 0-60 with cutoffs determining children at risk for developmental delay. Higher scores indicate less risk of developmental delay.
Measured: Interval change in developmental risk will be assessed over up to a 5 year period.
Presence of Any Social Need - Accountable Health Communities Social Needs Screening Items
Family social needs to be assessed at baseline and regular intervals include food insecurity, housing insecurity, transportation problems, utilities problems, and legal issues. All of these social needs are measured using the Accountable Health Communities Social Needs Screener and the presence of any of the above social needs will be interpreted as the presence of a social need. Social needs resource use will also be measured.
Measured: Interval change in presence of any social need will be assessed over up to a 5 year period.
Secondary outcomes (3)
Economic Stress - Family Economic Strain Scale.
Family economic stress will be measured using the Family Economic Strain Scale (FESS) score. The FESS has 15 items and ranges from a score of 5 to 75, with higher scores indicating less financial stress.
Measured: Interval change in FESS will be assessed over up to a 5 year period.
Parenting Self-Efficacy - Parenting Sense of Competence Scale
Parenting self-efficacy will be measured using the Parenting Sense of Competence Scale (PSOC). The PSOC is a 17 item scale with a range from 17 to 102, with higher scores indicating more parent competence.
Measured: Interval change in PSOC will be assessed over up to a 5 year period.
Pediatric Primary Care Visit Adherence
Pediatric primary care visit adherence will be measured as a rate for families in the study.
Measured: Interval change in pediatric primary care visit adherence will be assessed over up to a 5 year period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start7 Nov 2018
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Economic ProblemsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Schickedanz, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736590
- Sponsor's protocol ID
- UCLAHarborSchickedanzMFP
- Status last verified
- Jul 2026
- First submitted
- 7 Nov 2018
- Last updated
- 13 Jul 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Clinic-Based Financial Coaching on Health and Development
- ClinicalTrials.gov ID
- NCT03736590
- Acronym / sponsor ID
- UCLAHarborSchickedanzMFP
- Conditions
- Economic Problems, Development, Child, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 9 Nov 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.
This study will examine the impact of clinic-based financial coaching on parent health-related quality of life and child development measures, as well as family social needs for families with young children receiving pediatric care at a primary care practice in the Los Angeles County safety net.
Detailed description
With an expert group of researchers, financial coaches, and implementation scientists, we will study the impact of clinic-based financial coaching on parent health-related quality of life, child developmental risk, and social needs.We will conduct a clinical randomized controlled trial of financial coaching for low-income families. Parents of infants in a large pediatric primary care safety-net clinic will receive either 1) financial coaching from trained coaches plus social needs screening and resource navigation at all well child visits (intervention) or 2) social needs screening and navigation alone (active control) and will be followed for five years. Aims include:
1a) Examine parent outcomes of overall health-related quality of life (primary parent outcome);
1b) Examine child outcomes of developmental risk scores (primary child outcome) and well-child visit adherence;
1c) Examine family social needs outcomes, including incidence of any food insecurity, housing instability, transportation or utilities interruptions (primary family outcome any one or more) and resource use; and financial metrics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention - Financial Coaching Plus Social Needs Screening | Experimental | Behavioral: Financial coaching and servicesFamilies in this intervention arm will receive financial coaching at each well child visit, in addition to clinic-based social needs screening and referral. |
| Control - Social Needs Screening and Referral | Active comparator | Behavioral: Financial coaching and servicesFamilies in this active control arm will receive social needs screening and referral to community resources to address identified social needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents/caregivers in families with children 4 months or under at enrollment receiving care at Harbor-UCLA medical center clinic.
Key exclusion criteria (1 listed)
- Cognitive impairment or not speaking English or Spanish.
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 |
|---|---|---|
| Financial coaching and servicesThe intervention will consist of clinic-based financial coaching that focuses on improving financial stability through longitudinal visits with financial services professionals to address financial goals. | Behavioural | Control - Social Needs Screening and Referral, Intervention - Financial Coaching Plus Social Needs Screening |
Primary outcome
Health-Related Quality of Life (HRQOL) - Patient Reported Outcome Measurement Information System Global Health Short Form 10-Item Scale (PROMIS-10)
Time frame: Interval change in PROMIS-10 HRQOL will be assessed over up to a 5 year period.
Health-related quality of life will be measured at baseline and regular intervals using the Patient-Reported Outcomes Measurement Information System Global Health Short Form 10 (PROMIS 10). This will be the primary outcome for parents in the study. The PROMIS-10 measures overall health, physical health, mental health and social functioning and is scored on a T-scored range with 50 as the mean and 10 as the standard deviation. Higher scores indicate better HRQOL.
Developmental Risk - Ages and Stages Questionnaires
Time frame: Interval change in developmental risk will be assessed over up to a 5 year period.
Parent report of child developmental risk via clinic-based developmental questionnaires (Ages and Stages Questionnaires, ASQ) will be used to measure developmental risk. The ASQ measure contains sub-scales for each developmental domain (gross motor, fine motor, problem solving, communication, problem-solving, personal-social). Parent-reported ASQ items yield a score from 0-60 with cutoffs determining children at risk for developmental delay. Higher scores indicate less risk of developmental delay.
Presence of Any Social Need - Accountable Health Communities Social Needs Screening Items
Time frame: Interval change in presence of any social need will be assessed over up to a 5 year period.
Family social needs to be assessed at baseline and regular intervals include food insecurity, housing insecurity, transportation problems, utilities problems, and legal issues. All of these social needs are measured using the Accountable Health Communities Social Needs Screener and the presence of any of the above social needs will be interpreted as the presence of a social need. Social needs resource use will also be measured.
3 secondary outcomes
Economic Stress - Family Economic Strain Scale.
Time frame: Interval change in FESS will be assessed over up to a 5 year period.
Parenting Self-Efficacy - Parenting Sense of Competence Scale
Time frame: Interval change in PSOC will be assessed over up to a 5 year period.
Pediatric Primary Care Visit Adherence
Time frame: Interval change in pediatric primary care visit adherence will be assessed over up to a 5 year period.
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 13 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial coaching and services in people with Economic Problems and Development, Child, run by University of California, Los Angeles 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 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 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?
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?
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?
Health-Related Quality of Life (HRQOL) - Patient Reported Outcome Measurement Information System Global Health Short Form 10-Item Scale (PROMIS-10) (time frame: Interval change in PROMIS-10 HRQOL will be assessed over up to a 5 year period.). The study lists 3 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 13 Jul 2026.