This trial is active, not recruiting.

Condition developmental delays
Treatment patient decision aid
Sponsor Children's Hospital of Philadelphia
Start date December 2013
End date December 2016
Trial size 64 participants
Trial identifier NCT01941186, 13-010441


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
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.
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.
(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.

Primary Outcomes

Evaluation by Early Intervention Specialists
time frame: Up to 180 days

Secondary Outcomes

Parental Attitudes and Knowledge of Early Intervention
time frame: Up to 7 days

Eligibility Criteria

Male or female participants up to 36 months old.

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

Additional Information

Official title A Family Centered Intervention to Promote Optimal Child Development at the Interface of the Health System and Community
Principal investigator Alexander Fiks, MD, MSCE
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.