Developmental DelaysNCT01941186

A Family Centered Intervention to Promote Optimal Child Development

A study testing Patient Decision Aid in people with Developmental Delays, 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 2 days to 36 months
Conditions the study is for: Developmental Delays
What is being tested?: Patient Decision Aid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: Dec 2013to Jul 2016
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 2 days to 36 months
All sexes
No healthy volunteers
Child

Who may be able to join

Parent-child dyads in which the child is age 0 to 36 months screening positive for developmental concern and receiving care at a practice within Children's Hospital of Philadelphia Pediatric Research Consortium (PeRC).
Caregivers able to give permission (informed consent).

Who cannot join

Primary language other than English
Children already enrolled in early intervention

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Family Centered Intervention to Promote Optimal Child Development at the Interface of the Health System and Community

This is a randomized controlled trial aimed at assessing the effectiveness of a patient decision aid (PDA) and text message reminder in promoting early intervention referral completion when infants and toddlers are identified with a developmental concern in the pediatric medical home. Subjects will be randomized to one of two study arms- (1) intervention (2) control condition. Subjects in the intervention arm will watch a video PDA and will receive a text message reminder approximately 7 to 14 business days after enrollment if they agree to the early intervention referral.

Conditions: Developmental Delays
Being tested: Patient Decision Aid
Keywords: Children, Developmental Delays, Early Intervention (EI), Patient Decision Aid (PDA)

What participants receive

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

Patient Decision AidOther
Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.

Study groups in NCT01941186
Study group	Role	What they receive
Patient Decision Aid	Experimental	After positive screen for a developmental concern the intervention group will receive the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention. Receives: Other: Patient Decision Aid
Routine Care	No intervention	After screening positive for a potential development delay those in the control arm will receive routine care, in this case, a handout explaining Early Intervention services.

What is being measured

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

Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups
Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review. A member of the study team contacted parents within 6 months of the first study visit to obtain this information. Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed.
Measured: Up to 1 year after randomization

Secondary outcomes (1)

Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Pre and post knowledge and attitudes regarding developmental delay and early intervention (EI) were assessed by asking participants to respond to 14 statements using a 6 point Likert scale that ranged from strongly disagree to strongly agree. Questions mapped to the video decision aid content viewed by participants. Participants in the intervention arm completed the questions before and after watching the video and participants in the control arm completed the questions sequentially. Secondary outcome measures assessed in the survey included Parent Uncertainty About Early Intervention and Parental Predisposition for Early Intervention.
Measured: Up to 7 days

Timeline

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

Dec 2013Jul 2016

First posted13 Sep 2013 (estimated)
Study startDec 2013
Primary completionJul 2015
Study completionJul 2016

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.
Other trials for Developmental DelaysStudies 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01941186
Sponsor's protocol ID: 13-010441
Status last verified: Aug 2016
First submitted: 9 Sep 2013
Last updated: 21 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Family Centered Intervention to Promote Optimal Child Development at the Interface of the Health System and Community
ClinicalTrials.gov ID: NCT01941186
Acronym / sponsor ID: 13-010441
Conditions: Developmental Delays
Keywords: Children, Developmental Delays, Early Intervention (EI), Patient Decision Aid (PDA)
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Study start: Dec 2013
Primary completion: Jul 2015 (actual)
Study completion: Jul 2016 (actual)
First posted: 13 Sep 2013 (estimated)
Results: Posted 30 Aug 2016

Clinical summary

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

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Patient Decision Aid	Experimental	Other: Patient Decision AidAfter positive screen for a developmental concern the intervention group will receive the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Routine Care	No intervention	–After screening positive for a potential development delay those in the control arm will receive routine care, in this case, a handout explaining Early Intervention services.

Who may qualify

Ages: 2 days to 36 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Parent-child dyads in which the child is age 0 to 36 months screening positive for developmental concern and receiving care at a practice within Children's Hospital of Philadelphia Pediatric Research Consortium (PeRC).
Caregivers able to give permission (informed consent).

Key exclusion criteria (2 listed)

Primary language other than English
Children already enrolled in early intervention

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
Patient Decision AidShort informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.	Other	Patient Decision Aid

Primary outcome

Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups
Time frame: Up to 1 year after randomization
Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review. A member of the study team contacted parents within 6 months of the first study visit to obtain this information. Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed.

1 secondary outcome

Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Time frame: Up to 7 days

Results and safety

Results posted to the registry on 30 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patient Decision Aid	31	31
Routine Care	33	33

Primary outcome: Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups

Time frame: Up to 1 year after randomization. Number. Unit: participants

Measure	Patient Decision Aid n = 31	Routine Care n = 33
Early Intervention Intake	20	21
Early Intervention Evaluation	17	17

Population analysed: One parent-child dyad had missing information regarding EI intake and evaluation. Given the absence of information on referral outcome, this parent-child dyad was included in the final evaluation as having not received an EI intake and evaluation.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were monitored for the duration of participation (up to 1 year). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patient Decision Aid	0 of 31 (0%)	0 of 31 (0%)	Not reported
Routine Care	0 of 33 (0%)	0 of 33 (0%)	Not reported

Limitations and caveats (from the sponsor): Given that the study recruited a convenience sample from one primary care network, findings may not be generalizable to all settings. Also worth noting, EI services differ by state and some of the information is not applicable in all states.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Recruiting
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Active, not recruiting
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Not yet recruiting
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Active, not recruiting
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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.

Alexander Fiks, MD, MSCE principal investigator

Children's Hospital of Philadelphia

Manuel Jimenez, MD, MS 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 Patient Decision Aid in people with Developmental Delays, 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 2 inclusion and 2 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 21 Oct 2016. 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 30 Aug 2016). 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?

Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups (time frame: Up to 1 year after randomization). 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 NCT01941186.

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 21 Oct 2016.