ParentingEarly Phase 1NCT03146572
Primary Care and Parenting
A Early Phase 1 study testing Sit Down and Play and Handout in people with Parenting and Knowledge, Attitudes, Practice, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
The objective of this study to evaluate potential impact of a brief, low-cost primary care-based intervention of parenting self-efficacy, knowledge, and behavior. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Parenting, Knowledge, Attitudes, Practice, Development, Child
- What is being tested?
- Sit Down and Play and Handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2017to 6 Apr 2018
- Phase
- Early Phase 1
- 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 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent is 18 years or older Child is present for a 6, 9, or 12 month well-child visit who attends University of Illinois at Chicago (UIC) for well-child care Adult present with child at appointment is parent/caregiver of child
Who cannot join
- Parent is non-English speaking Child is acutely sick
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Utilizing the Primary Care Setting to Deliver a Brief Program to Enhance Parenting Behaviors
The objective of this study to evaluate potential impact of a brief, low-cost primary care-based intervention of parenting self-efficacy, knowledge, and behavior.
Read the detailed description
Enriching parenting behaviors in early childhood promotes child development and offers a promising strategy to reduce future educational disparities. However, current interventions are limited by cost and have not been widely disseminated. Recognized as a target for research to improve early childhood development and subsequent school readiness skills among at-risk families, the primary care setting offers an ideal opportunity to reach the millions of children living in poverty. However, what remains unknown is how to more efficiently leverage the primary care setting to deliver a sustainable and effective preventive program to promote positive parenting behaviors and encourage early childhood development in low-income families. Therefore, the investigators designed Sit Down and Play (SDP) a brief parent-directed program delivered in the primary care setting. Modeled after the widely disseminated literacy program Reach Out and Read and grounded in social cognitive theory, SDP is intended to take place during each pediatric well-child visit occurring in a child's first two years with the goal of promoting positive parenting behaviors.
- Being tested
- Sit Down and Play, Handout
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit Down and PlayBehavioural
Also called Handout
Sit Down and Play (SDP) is designed to be a brief, low-cost intervention that incorporates key theoretical constructs to elicit positive parenting behaviors. It is intended to be delivered by existing clinical staff, nonprofessionals, or volunteers during each of the eight well-child visits between 2-24 months of age while a family waits to be seen by their pediatrician in the examination room
HandoutOther
Handout providing written descriptions of strategies to encourage positive parenting behaviors
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Parent of child to receive intervention, Sit Down and Play Receives: Behavioral: Sit Down and Play |
| Control | Active comparator | Parent will receive handout to promote positive behavior Receives: Other: Handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parental Knowledge
Change in parental knowledge regarding importance of talking with children
Measured: Enrollment and 7 months post-enrollment
Change in participation in cognitively stimulating activities
Change in participation in cognitively stimulating activities such as reading and play as measured by the StimQ
Measured: Enrollment and 7 months post-enrollment
Change in parenting self-efficacy
Change in perceived self-efficacy in parenting activity as measured by The Tool to Measure Parenting Self Efficacy
Measured: Enrollment and 7 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start3 Apr 2017
- Primary completion11 Feb 2018
- Study completion6 Apr 2018
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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Developmental and Behavioral Pediatrics
- Responsible party
- Principal investigator, Reshma Shah, MD, University of Illinois at Chicago
- Investigators
- Reshma Shah, MD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146572
- Sponsor's protocol ID
- 2014-0337_2
- Other IDs
- SDBP
- Status last verified
- Feb 2020
- First submitted
- 7 May 2017
- Last updated
- 13 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing the Primary Care Setting to Deliver a Brief Program to Enhance Parenting Behaviors
- ClinicalTrials.gov ID
- NCT03146572
- Acronym / sponsor ID
- 2014-0337_2
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- Society of Developmental and Behavioral Pediatrics
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 11 Feb 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 10 May 2017 (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 objective of this study to evaluate potential impact of a brief, low-cost primary care-based intervention of parenting self-efficacy, knowledge, and behavior.
Detailed description
Enriching parenting behaviors in early childhood promotes child development and offers a promising strategy to reduce future educational disparities. However, current interventions are limited by cost and have not been widely disseminated. Recognized as a target for research to improve early childhood development and subsequent school readiness skills among at-risk families, the primary care setting offers an ideal opportunity to reach the millions of children living in poverty. However, what remains unknown is how to more efficiently leverage the primary care setting to deliver a sustainable and effective preventive program to promote positive parenting behaviors and encourage early childhood development in low-income families. Therefore, the investigators designed Sit Down and Play (SDP) a brief parent-directed program delivered in the primary care setting. Modeled after the widely disseminated literacy program Reach Out and Read and grounded in social cognitive theory, SDP is intended to take place during each pediatric well-child visit occurring in a child's first two years with the goal of promoting positive parenting behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Sit Down and PlayParent of child to receive intervention, Sit Down and Play |
| Control | Active comparator | Other: HandoutParent will receive handout to promote positive behavior |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parent is 18 years or older Child is present for a 6, 9, or 12 month well-child visit who attends University of Illinois at Chicago (UIC) for well-child care Adult present with child at appointment is parent/caregiver of child
Key exclusion criteria (1 listed)
- Parent is non-English speaking Child is acutely sick
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 |
|---|---|---|
| Sit Down and PlayAlso: HandoutSit Down and Play (SDP) is designed to be a brief, low-cost intervention that incorporates key theoretical constructs to elicit positive parenting behaviors. It is intended to be delivered by existing clinical staff, nonprofessionals, or volunteers during each of the eight well-child visits between 2-24 months of age while a family waits to be seen by their pediatrician in the examination room | Behavioural | Intervention |
| HandoutHandout providing written descriptions of strategies to encourage positive parenting behaviors | Other | Control |
Primary outcome
Change in Parental Knowledge
Time frame: Enrollment and 7 months post-enrollment
Change in parental knowledge regarding importance of talking with children
Change in participation in cognitively stimulating activities
Time frame: Enrollment and 7 months post-enrollment
Change in participation in cognitively stimulating activities such as reading and play as measured by the StimQ
Change in parenting self-efficacy
Time frame: Enrollment and 7 months post-enrollment
Change in perceived self-efficacy in parenting activity as measured by The Tool to Measure Parenting Self Efficacy
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 Feb 2020.
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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.
Reshma Shah, MD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sit Down and Play and Handout in people with Parenting and Knowledge, Attitudes, Practice, run by University of Illinois at Chicago 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 13 Feb 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Parental Knowledge (time frame: Enrollment and 7 months post-enrollment). 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 Feb 2020.