ParentingPhase 2NCT01405404
Engaging Low-Income Families in Prevention Programs
A Phase 2 study testing Parent Training and childcare discount and Parent Training in people with Parenting, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purposes of this study are to (1) study the cost-effectiveness of childcare discounts on increasing parent participation rates in a preventive parent training program called the Chicago Parent Program and (2) evaluate the efficacy of the Spanish-translated version of the Chicago Parent Program in childcare centers… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting
- What is being tested?
- Parent Training and childcare discount and Parent Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2012
- Phase
- Phase 2
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- parent of 2-4 year old child enrolled in participating day care center
Who cannot join
- parent previously participated in parent training program
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
The purposes of this study are to (1) study the cost-effectiveness of childcare discounts on increasing parent participation rates in a preventive parent training program called the Chicago Parent Program and (2) evaluate the efficacy of the Spanish-translated version of the Chicago Parent Program in childcare centers serving low-income families with young children.
- Conditions
- Parenting
- Being tested
- Parent Training and childcare discount, Parent Training
- Keywords
- parenting childcare discounts child behavior, No Intervention Control, Intervention no childcare discount, Intervention with childcare discount
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Training and childcare discountBehavioural
Also called Chicago Parent Program
12-session parent training intervention called the Chicago Parent Program; Childcare discount given in one arm to examine its effect on attendance rate
Parent TrainingOther
Also called Chicago Parent Program
12-session group on parenting skills and child behavior management
| Study group | Role | What they receive |
|---|---|---|
| No intervention control | No intervention | Parents complete surveys only |
| parent training but no discount | Experimental | parent enrolled in the parent training intervention but do not receive childcare discounts for attending Receives: Behavioral: Parent Training and childcare discount |
| Parent training with discount | Experimental | parents receive parent training and a childcare discount for attending Receives: Other: Parent Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child behavior problems
Change from baseline to 15 months later on three measures of child behavior problems are used: parent-report (CBCL), teacher-report (CTRF), and observer rating (DPICS)
Measured: baseline, 3-months, 9-months, 15-months
Secondary outcomes (2)
Changing in parenting behavior
change from baseline to 15 months later on parent-report measures(parenting self-efficacy, use of corporal punishment) and observer ratings of parent behavior (use of praise, critical statements, commands, physical negative behaviors, physical positive behaviors) are evaluated
Measured: baseline, 3-months, 9-months, 15-months
Participation rate
Enrollment rate is measured at baseline, and number of intervention sessions attended and degree to which parents were actively engaged in the intervention sessions are measured 3 months later at post-intervention
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJan 2007
- Primary completionJun 2011
- Study completionJun 2012
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.
- More trials run by Rush University Medical CenterThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Deborah Gross, Rush University Medical Center
- Investigators
- Deborah A Gross, DNSc, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405404
- Sponsor's protocol ID
- L05031502
- Other IDs
- R01NR004085
- Status last verified
- May 2013
- First submitted
- 21 Jul 2011
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Low-Income Families in Prevention Programs
- ClinicalTrials.gov ID
- NCT01405404
- Acronym / sponsor ID
- L05031502
- Conditions
- Parenting
- Keywords
- parenting childcare discounts child behavior, No Intervention Control, Intervention no childcare discount, Intervention with childcare discount
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jan 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Jul 2011 (estimated)
- 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 purposes of this study are to (1) study the cost-effectiveness of childcare discounts on increasing parent participation rates in a preventive parent training program called the Chicago Parent Program and (2) evaluate the efficacy of the Spanish-translated version of the Chicago Parent Program in childcare centers serving low-income families with young children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention control | No intervention | –Parents complete surveys only |
| parent training but no discount | Experimental | Behavioral: Parent Training and childcare discountparent enrolled in the parent training intervention but do not receive childcare discounts for attending |
| Parent training with discount | Experimental | Other: Parent Trainingparents receive parent training and a childcare discount for attending |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- parent of 2-4 year old child enrolled in participating day care center
Key exclusion criteria (1 listed)
- parent previously participated in parent training program
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 |
|---|---|---|
| Parent Training and childcare discountAlso: Chicago Parent Program12-session parent training intervention called the Chicago Parent Program; Childcare discount given in one arm to examine its effect on attendance rate | Behavioural | parent training but no discount |
| Parent TrainingAlso: Chicago Parent Program12-session group on parenting skills and child behavior management | Other | Parent training with discount |
Primary outcome
Change in child behavior problems
Time frame: baseline, 3-months, 9-months, 15-months
Change from baseline to 15 months later on three measures of child behavior problems are used: parent-report (CBCL), teacher-report (CTRF), and observer rating (DPICS)
2 secondary outcomes
Changing in parenting behavior
Time frame: baseline, 3-months, 9-months, 15-months
Participation rate
Time frame: baseline and 3 months
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 7 May 2013.
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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.
Deborah A Gross, DNSc principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parent Training and childcare discount and Parent Training in people with Parenting, run by Rush University 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 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: finished, as of the sponsor's last update on 7 May 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 child behavior problems (time frame: baseline, 3-months, 9-months, 15-months). 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 7 May 2013.