Skip to main content
OpenTrials
Completed

NCT Number: NCT01941186

A Family Centered Intervention to Promote Optimal Child Development

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Developmental Delays

Age range

2 day–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Up to 7 days

    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.

Other outcomes

  1. Parent Uncertainty About Early Intervention

    Time frame: Up to 7 days

    Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.

  2. Parental Predisposition for Early Intervention

    Time frame: Up to 7 days

    Parental predisposition for early intervention services will be measured using surveys.

  3. Feasibility of the Patient Decision Aid

    Time frame: Up to 7 days

    The feasibility of the patient decision aid (PDA) will be measured by calculating the number of individuals who refuse to participate, time that it takes to complete the PDA, and the number of patients who complete the Early Intervention referral.

  4. Acceptability of the Patient Decision Aid for Early Intervention Referral

    Time frame: Up to 7 days

    The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Sep 13, 2013
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.