Parent-Child RelationsLPNCT04576481

Literacy Promotion Using Automated Hovering

A study testing Texting, Regret and Lottery in people with Parent-Child Relations and Parenting, run by Children's Hospital of Philadelphia at 1 site in United States.

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

Who is it for?: Ages 6 to 24 monthsHealthy volunteers can take part
Conditions the study is for: Parent-Child Relations, Parenting, Literacy
What is being tested?: Texting, Regret and Lottery
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteUnited States
Study dates: 17 Nov 2020to 4 Feb 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Parents who:
Have an infant aged 6-24 months
Have access to a smart phone with text messaging capabilities
Have completed an informed consent
Children who:
Are aged 6-24 months old

Who cannot join

Parents who:
Non-English speaking
Children who:
Were born premature (estimated gestational age < 35 weeks)
Have been diagnosed with congenital malformations or genetic syndromes which place them at risk for developmental delays

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146

Other trials in United States

About this study

Official title: Literary Promotion Using Automated Hovering to Improve Development in Young Low-Income Children

The purpose of this study is to incorporate behavioral economics (BE) approaches to determine whether 3 novel interventions of varying intensity improve the frequency of parent-child reading behaviors among low-income families. In the first phase, 10 parents will be recruited to participate in rapid cycle interviews to determine the appropriateness of text messages. In the second phase, 45 participants will be randomized to comparative groups to test the effects of automated hovering and other BE approaches on frequency of parent-child shared reading. Investigators long-term goal is to test the effects of these approaches to promote child language and socio-emotional development.

Read the detailed description

Early childhood is a sensitive period in which young children develop language and socio-emotional skills foundational for school readiness. Unfortunately, poor vulnerable children experience disparities in these critical areas of development. Parent-child shared reading can help ameliorate these disparities, yet low-income parents do not consistently engage in this activity. Behavioral economics approaches utilizing automated hovering (AH) have the potential to increase parent-child shared reading through text messages and financial inducements.

The study design is a two-phase study consisting of a qualitative component followed by a prospective, randomized comparative group trial to test the effects of AH approaches to increase parent-child shared reading. A total of 55 eligible children and their parents will be recruited from participating practices to achieve a diverse sample of children.

In the first phase, 10 parents will be recruited to participate in brief rapid cycle interviews to assess the appropriateness of text message reminders. In the second phase, forty-five participants will be randomized 1:1:1 to receive one of the 3 AH interventions: 1) daily text message reminders (texting), 2) daily text message reminders with social comparisons (regret) or 3) daily text message reminders with social comparisons and weekly lottery entries (lottery). All interventions are related to principles of behavioral economics in order to provide external motivation. There will be 15 participants per group to adequately assess feasibility and acceptability, the primary outcome.

Descriptive statistics for demographic, home reading environment, and parenting stress measured at baseline will be examined across the three groups to assess the success of the randomization. To assess feasibility and acceptability, Investigators will assess the proportion of participants who receive and report a daily reading behavior each week across all groups, the proportion of participants who access coaching content in group 2 \& 3, and the proportion of participants who participate in the weekly lottery in group 3, and satisfaction scores in all groups. Secondary outcomes including differences between groups in weekly reading frequency, home reading environment, and child socio-emotional scores between groups will be assessed using standard inferential statistics and intention-to-treat analysis.

The results of this study may assist health care providers and researchers in testing the feasibility of AH approaches to improve parent-child shared reading and prepare for a larger efficacy trial.

Conditions: Parent-Child Relations, Parenting, Literacy
Being tested: Texting, Regret, Lottery
Medical subject headings: Literacy

What participants receive

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

TextingBehavioural
Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
RegretBehavioural
Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
LotteryBehavioural
Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.

Study groups in NCT04576481
Study group	Role	What they receive
Group 1: Texting	Active comparator	Consist of daily text messages on shared reading Receives: Behavioral: Texting
Group 2: Regret	Experimental	Will consist of Group 1 plus social comparisons. Receives: Behavioral: Texting; Behavioral: Regret
Group 3: Lottery	Experimental	Will consist of Group 2 plus availability of a weekly lottery. Receives: Behavioral: Texting; Behavioral: Regret; Behavioral: Lottery

What is being measured

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

Acceptability Survey
To determine acceptability, participants will be assessed on their overall satisfaction (5-point Likert scale 1=strong disagree, 2=disagree, 3=not sure, 4=agree and 5= strongly agree) with the study delivery intervention and answered survey questions regarding likes and dislikes concerning the intervention group they received following the intervention period.
Measured: 2 months
Feasibility of Study
Percentage of study participants who completed the 2-month follow-up
Measured: 2 months

Secondary outcomes (5)

Change in Score of Cognitive Stimulation Provided in the Home Measure - (StimQ-Read)
To determine change in home reading environment, Investigators will examine differences in the Read subscale of the measure of Cognitive Stimulation provided in the home (StimQ) from baseline to 2 months. The Read subscale of the StimQ is a validated 14-item parent self-report questionnaire designed to measure of the home reading environment for children ages 5 to 72 months of age with a maximum score of 18 and a minimum score of 0. The higher score indicates a better home reading environment. The change in score from baseline to follow-up (2-months) will be used.
Measured: 2 months
Change in Score for The Parenting Stress Index - Short Form (PSI-SF)
To determine change in parenting stress, Investigators will examine differences in the Parenting Stress Index- Short Form (PSI-SF) from baseline to follow-up (2 months). The PSI-SF is a validated 36-item scale that measures parenting stress, and it has been shown to have excellent internal consistency and to be positively associated with maternal psychological distress. The scores can range from 36 to 180 with an higher scores overall indicating higher levels of parenting stress. The change in score from baseline to follow-up (2-months) will be used.
Measured: 2 months
Change in Weekly Parent-Child Shared Reading Frequency
Investigators will measure reading frequency as the average number of days per week of reported parent-child shared reading.
This is a measure of parent's self-reported reading frequency using question 2 from Cognitive Stimulation Provided in the Home Measure Reading Subscales, Parents are asked "How many days each week do you read children's books to your child?". Scores will be collected at baseline and at the 2-month follow-up. Change in reading frequency will be computed by subtracting the days reading at baseline from the days reading at follow-up.
Measured: 2 months
Measure of Child Socio-Emotional Development Using Devereux Early Childhood Assessment (DECA)
Investigators will measure child socio-emotional development at 2 months using the Devereax Early Childhood Assessment (DECA), a validated 33-item parent report of social emotional problems for children 9-36 months of age. All 33 items are used to calculate the raw total protective factor (TPF). 18/33 items are used to calculate raw Initiative sub scale (infant's ability to use independent thought and action to meet his/her needs). 15/33 items are used to calculate raw Attachment/Relationships sub scale (mutual, strong, long-lasting relationship between the infant and significant adults such as family members, and teachers). Higher scores indicate greater social emotional development.
For all 33 items parents can report (Never 0, Rarely 1, Occasionally 2, Frequently 3, Very Frequently 4). Raw total scores can range from 0-132, with higher scores indicating a better outcome.
Measured: 2 months
Measure of Child Language Development Using MacArthur Communicative Development Inventory (CDI) - Percentiles
Investigators measured child language development at 2 months using the MacArthur Communicative Development Inventory (CDI), a validated parent report scale of early child language development for children 8-30 months of age. Parents are asked to indicate the words their child understands but does not yet say in the first column (understands). For words that their child understands, Parents are asked to indicate which words their child says in the second column (understand and says).
The raw total scores are inputted into a norming table for the CDI where a production (understand and says) and comprehension (understands) scores are generated based on the child's age and gender. Total scores can range from (0-178) with higher scores on the norming chart correlating to a higher percentile in comprehension or production. Total score is calculated by using summed scores where: blank = 0, understands = 1 and understands and speaks=2. Total scores were converted to percentile scores.
Measured: 2 months

Timeline

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

17 Nov 20204 Feb 2022

First posted6 Oct 2020
Study start17 Nov 2020
Primary completion4 Feb 2022
Study completion4 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: The intervention consists of 3 intervention groups. Participants will be stratified by site and randomized 1:1:1 to receive one of the 3 AH interventions for an 8-week duration.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04576481
Sponsor's protocol ID: 19-017199
Acronym: LP
Status last verified: Sep 2024
First submitted: 25 Sep 2020
Last updated: 15 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: A complete, cleaned, and de-identified dataset will be made available to other investigators after all analyses have been conducted and within twelve months of the end of the final year of funding to allow for publication of all study aims. To obtain this data set, other investigators will need to contact the study Principal Investigator (PI) who will provide a data sharing agreement. The data sharing agreement will permit a deidentified data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available on a Compact Disc Read-Only Memory (CD-ROM) or through a secure File Transfer Protocol (FTP) site.

Publications

National Research Council (US) and Institute of Medicine (US) Committee on Integrating the Science of Early Childhood Development; Shonkoff JP, Phillips DA, editors. From Neurons to Neighborhoods: The Science of Early Childhood Development. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225557/
PubMed 25077268
Rosenberg SA, Zhang D, Robinson CC. Prevalence of developmental delays and participation in early intervention services for young children. Pediatrics. 2008 Jun;121(6):e1503-9. doi: 10.1542/peds.2007-1680. Epub 2008 May 26.
PubMed 18504295
Blair C, Raver CC. Poverty, Stress, and Brain Development: New Directions for Prevention and Intervention. Acad Pediatr. 2016 Apr;16(3 Suppl):S30-6. doi: 10.1016/j.acap.2016.01.010.
PubMed 27044699
The pediatrician's role in development and implementation of an Individual Education Plan (IEP) and/or an Individual Family Service Plan (IFSP). American Academy of Pediatrics. Committee on Children with Disabilities. Pediatrics. 1999 Jul;104(1 Pt 1):124-7. doi: 10.1542/peds.104.1.124.
PubMed 10390275
Centers for Disease Control and Prevention (CDC). Economic costs associated with mental retardation, cerebral palsy, hearing loss, and vision impairment--United States, 2003. MMWR Morb Mortal Wkly Rep. 2004 Jan 30;53(3):57-9.
PubMed 14749614
Cates CB, Dreyer BP, Berkule SB, White LJ, Arevalo JA, Mendelsohn AL. Infant communication and subsequent language development in children from low-income families: the role of early cognitive stimulation. J Dev Behav Pediatr. 2012 Sep;33(7):577-85. doi: 10.1097/DBP.0b013e318264c10f.
PubMed 22947884
Hart B, Risley TR. Meaningful differences in the everyday experience of young American children. Baltimore, MD: Paul Brookes Publishing Company; 1995.
Zuckerman B, Augustyn M. Books and reading: evidence-based standard of care whose time has come. Acad Pediatr. 2011 Jan-Feb;11(1):11-7. doi: 10.1016/j.acap.2010.09.007.
PubMed 21272819
Payne AC, Whitehurst GJ, Angell aL. The role of home literacy environment in the development of language ability in preschool children from low-income families. Early Child Res Q. 1994:427-440.
Weinberger J. A longitudinal study of children's early literacy experiences at home and later literacy development at home and school. J Res Reading. 1996;19:14-24.
Senechal M, Lefevre J, Thomas EM, Daley KE. Differential effects of home literacy experiences on the development of oral and written language. Reading Res Q. 1998;33:96-116.
Jimenez ME, Mendelsohn AL, Lin Y, Shelton P, Reichman N. Early Shared Reading Is Associated with Less Harsh Parenting. J Dev Behav Pediatr. 2019 Sep;40(7):530-537. doi: 10.1097/DBP.0000000000000687.
PubMed 31107765
Jimenez ME, Hudson SV, Lima D, Mendelsohn AL, Pellerano M, Crabtree BF. Perspectives on shared reading among a sample of Latino parents. Child Care Health Dev. 2019 Mar;45(2):292-299. doi: 10.1111/cch.12634. Epub 2018 Dec 19.
PubMed 30471139
Mendelsohn AL, Mogilner LN, Dreyer BP, Forman JA, Weinstein SC, Broderick M, Cheng KJ, Magloire T, Moore T, Napier C. The impact of a clinic-based literacy intervention on language development in inner-city preschool children. Pediatrics. 2001 Jan;107(1):130-4. doi: 10.1542/peds.107.1.130.
PubMed 11134446
Asch DA, Muller RW, Volpp KG. Automated hovering in health care--watching over the 5000 hours. N Engl J Med. 2012 Jul 5;367(1):1-3. doi: 10.1056/NEJMp1203869. Epub 2012 Jun 20. No abstract available.
PubMed 22716935

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Literary Promotion Using Automated Hovering to Improve Development in Young Low-Income Children
ClinicalTrials.gov ID: NCT04576481
Acronym / sponsor ID: LP / 19-017199
Conditions: Parent-Child Relations, Parenting, Literacy
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: University of Pennsylvania
Study start: 17 Nov 2020 (actual)
Primary completion: 4 Feb 2022 (actual)
Study completion: 4 Feb 2022 (actual)
First posted: 6 Oct 2020 (actual)
Results: Posted 15 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The results of this study may assist health care providers and researchers in testing the feasibility of AH approaches to improve parent-child shared reading and prepare for a larger efficacy trial.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: The intervention consists of 3 intervention groups. Participants will be stratified by site and randomized 1:1:1 to receive one of the 3 AH interventions for an 8-week duration.

Arm	Type	Receives
Group 1: Texting	Active comparator	Behavioral: TextingConsist of daily text messages on shared reading
Group 2: Regret	Experimental	Behavioral: Texting, Behavioral: RegretWill consist of Group 1 plus social comparisons.
Group 3: Lottery	Experimental	Behavioral: Texting, Behavioral: Regret, Behavioral: LotteryWill consist of Group 2 plus availability of a weekly lottery.

Who may qualify

Ages: 6 to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Parents who:
Children who:

Key exclusion criteria (5 listed)

Parents who:
Children who:

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
TextingText Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.	Behavioural	Group 1: Texting, Group 2: Regret, Group 3: Lottery
RegretPersonalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.	Behavioural	Group 2: Regret, Group 3: Lottery
LotteryParticipants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.	Behavioural	Group 3: Lottery

Primary outcome

Acceptability Survey
Time frame: 2 months
To determine acceptability, participants will be assessed on their overall satisfaction (5-point Likert scale 1=strong disagree, 2=disagree, 3=not sure, 4=agree and 5= strongly agree) with the study delivery intervention and answered survey questions regarding likes and dislikes concerning the intervention group they received following the intervention period.
Feasibility of Study
Time frame: 2 months
Percentage of study participants who completed the 2-month follow-up

5 secondary outcomes

Change in Score of Cognitive Stimulation Provided in the Home Measure - (StimQ-Read)
Time frame: 2 months
Change in Score for The Parenting Stress Index - Short Form (PSI-SF)
Time frame: 2 months
Change in Weekly Parent-Child Shared Reading Frequency
Time frame: 2 months
Measure of Child Socio-Emotional Development Using Devereux Early Childhood Assessment (DECA)
Time frame: 2 months
Measure of Child Language Development Using MacArthur Communicative Development Inventory (CDI) - Percentiles
Time frame: 2 months

Results and safety

Results posted to the registry on 15 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1	10	10
Phase 2 Texting Arm: Text Messaging Only	0	0
Phase 2 Regret Arm: Text Messaging + Coaching	0	0
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery	0	0

Primary outcome: Acceptability Survey

Time frame: 2 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Phase 2 Texting Arm: Text Messaging n = 14	Phase 2 Regret Arm: Text Messaging + Coaching n = 13	Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery n = 15
Value	4 (1.1)	3.3 (1.3)	3.8 (1.2)

Population analysed: A total of 42 participant completed the measure. 3 participants were lost to follow-up

Primary outcome: Feasibility of Study

Time frame: 2 months. Count of participants. Unit: Participants

Measure	Phase 2 Texting Arm: Text Messaging Only n = 15	Phase 2 Regret Arm: Text Messaging + Coaching n = 15	Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery n = 15	Phase 1 n = 10
Value	14	13	15	10

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year, 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: Rapid Cycle Interviews	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Phase 2 Texting Arm: Text Messaging	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Phase 2 Regret Arm: Text Messaging + Coaching	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Limitations and caveats (from the sponsor): * Technical issues with W2H system: Group 2 texts that provided comparisons of participant reading frequency with that of other participant did not work properly for duration of study. * Problem with Measurements leading to lost data: * CDI \& DECA: data lost for participants \>18 mo at follow-up visit * CDI: technical problems with RedCap data collection. Comprehension scores are uninterpretable. Only production scores were used in data analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25077268National Research Council (US) and Institute of Medicine (US) Committee on Integrating the Science of Early Childhood Development; Shonkoff JP, Phillips DA, editors. From Neurons to Neighborhoods: The Science of Early Childhood Development. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225557/
Background: PubMed 18504295Rosenberg SA, Zhang D, Robinson CC. Prevalence of developmental delays and participation in early intervention services for young children. Pediatrics. 2008 Jun;121(6):e1503-9. doi: 10.1542/peds.2007-1680. Epub 2008 May 26.
Background: PubMed 27044699Blair C, Raver CC. Poverty, Stress, and Brain Development: New Directions for Prevention and Intervention. Acad Pediatr. 2016 Apr;16(3 Suppl):S30-6. doi: 10.1016/j.acap.2016.01.010.
Background: PubMed 10390275The pediatrician's role in development and implementation of an Individual Education Plan (IEP) and/or an Individual Family Service Plan (IFSP). American Academy of Pediatrics. Committee on Children with Disabilities. Pediatrics. 1999 Jul;104(1 Pt 1):124-7. doi: 10.1542/peds.104.1.124.
Background: PubMed 14749614Centers for Disease Control and Prevention (CDC). Economic costs associated with mental retardation, cerebral palsy, hearing loss, and vision impairment--United States, 2003. MMWR Morb Mortal Wkly Rep. 2004 Jan 30;53(3):57-9.
Background: PubMed 22947884Cates CB, Dreyer BP, Berkule SB, White LJ, Arevalo JA, Mendelsohn AL. Infant communication and subsequent language development in children from low-income families: the role of early cognitive stimulation. J Dev Behav Pediatr. 2012 Sep;33(7):577-85. doi: 10.1097/DBP.0b013e318264c10f.
BackgroundHart B, Risley TR. Meaningful differences in the everyday experience of young American children. Baltimore, MD: Paul Brookes Publishing Company; 1995.
Background: PubMed 21272819Zuckerman B, Augustyn M. Books and reading: evidence-based standard of care whose time has come. Acad Pediatr. 2011 Jan-Feb;11(1):11-7. doi: 10.1016/j.acap.2010.09.007.
BackgroundPayne AC, Whitehurst GJ, Angell aL. The role of home literacy environment in the development of language ability in preschool children from low-income families. Early Child Res Q. 1994:427-440.
BackgroundWeinberger J. A longitudinal study of children's early literacy experiences at home and later literacy development at home and school. J Res Reading. 1996;19:14-24.
BackgroundSenechal M, Lefevre J, Thomas EM, Daley KE. Differential effects of home literacy experiences on the development of oral and written language. Reading Res Q. 1998;33:96-116.
Background: PubMed 31107765Jimenez ME, Mendelsohn AL, Lin Y, Shelton P, Reichman N. Early Shared Reading Is Associated with Less Harsh Parenting. J Dev Behav Pediatr. 2019 Sep;40(7):530-537. doi: 10.1097/DBP.0000000000000687.
Individual participant dataSharing planned: Yes. A complete, cleaned, and de-identified dataset will be made available to other investigators after all analyses have been conducted and within twelve months of the end of the final year of funding to allow for publication of all study aims. To obtain this data set, other investigators will need to contact the study Principal Investigator (PI) who will provide a data sharing agreement. The data sharing agreement will permit a deidentified data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available on a Compact Disc Read-Only Memory (CD-ROM) or through a secure File Transfer Protocol (FTP) site.

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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.

James Guevara, MD, MPH principal investigator

Children's Hospital of Philadelphia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Texting, Regret and Lottery in people with Parent-Child Relations and Parenting, run by Children's Hospital of Philadelphia 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 6 inclusion and 5 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 15 Nov 2024. 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?

Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Acceptability Survey (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04576481, which also lists 25 linked publications.

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 15 Nov 2024; AzTrials last refreshed its copy on 28 Oct 2026.