Empower EI: Comparing Early Intervention Approaches for Toddlers with Developmental Delays
This study, called Empower EI, is looking at three different ways to help toddlers (ages 12 to 31 months) with developmental delays improve their communication. All children in the study are already receiving early intervention (EI) speech therapy. One group will have their speech therapist work directly with them. Another group's therapist will coach their caregiver on how to help their child communicate. The third group will have their therapist work directly with the child, and their caregiver will also participate in a separate parent education program. Researchers want to see which approach works best to improve communication skills and help families. The study plans to enroll 1269 toddlers.
- Study design
- This is an interventional study planning to enroll 1269 toddlers. Participants will be randomly assigned to one of three early intervention approaches.
- What's involved
- Your child will receive weekly, hour-long early intervention sessions for 28 weeks. If assigned to the combined approach, caregivers will also attend weekly, one-hour virtual sessions for 14 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your child's progress will be measured at Week 14 and Week 28.
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Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Megan Roberts, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Responsive Strategy Use (RSU) Rating ScaleWeek 14, Week 28
The Responsive Strategy Use (RSU) Rating Scale will be used to measure caregivers' use of responsive strategies during a naturalistic, caregiver-child interaction. Items on the RSU Rating Scale are rated on a 4-point Likert Scale (0 = Rarely/Never, 3 = Consistently) and averaged to yield the RSU Total Score (Min = 0, Max = 3), with higher scores reflecting a higher frequency of responsive strategy use.
- Family Outcomes Survey - RevisedWeek 14, Week 28
The Family Outcomes Survey-Revised is a 24-item informant-report questionnaire that assesses caregivers' understanding, confidence, and ability to support their child's needs. The Family Outcomes Total Score (Min = 24, Max = 120) reflects the caregiver's capacity to support their child's needs, with higher scores indicating greater capacity.
- Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)Week 28
The Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP) is a structured, norm-referenced, observational measure of child communication. The assessment is scored for 20 items across 7 domains (i.e., Emotion and Eye Gaze, Communication, Gestures, Sounds, Words, Understanding, Object Use). The weighted raw scores for each of the 7 domains are grouped into 3 clusters (social, speech, and symbolic) and combined into a total raw score (min = 0; max = 113). Higher scores indicate better skills.