A Family Centered Intervention to Promote Optimal Child Development

NCT ID: NCT01941186

Last Updated: 2016-10-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Developmental Delays

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Patient Decision Aid

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.

Group Type EXPERIMENTAL

Patient Decision Aid

Intervention Type 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.

Routine Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Patient Decision Aid

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* Primary language other than English
* Children already enrolled in early intervention
Minimum Eligible Age

2 Days

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Fiks, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Manuel Jimenez, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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13-010441

Identifier Type: -

Identifier Source: org_study_id

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