A Family Centered Intervention to Promote Optimal Child Development

NCT01941186 | Completed Results

• 1 other identifier: 13-010441
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Children; Developmental Delays; Early Intervention (EI); Patient Decision Aid (PDA)

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 year after randomization

Secondary Outcomes (1)

• Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention

  Up to 7 days

Other Outcomes (4)

• Parent Uncertainty About Early Intervention

  Up to 7 days

• Parental Predisposition for Early Intervention

  Up to 7 days

• Feasibility of the Patient Decision Aid

  Up to 7 days

Study Arms (2)

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.

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.

Interventions

Patient Decision Aid OTHER

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.

Patient Decision Aid

Eligibility Criteria

• Age: 2 Days - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Primary language other than English
• Children already enrolled in early intervention

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Manuel Jimenez, MD, MS
• Organization: Child Health Institute of New Jersey

jimenema@rwjms.rutgers.edu

732-235-6230

Study Officials

• Alexander Fiks, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Manuel Jimenez, MD, MS

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 13, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: October 21, 2016
• Results First Posted: August 30, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)