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Behavioural Intervention
Parental Interventions for Young Children with Autism
Phase 2
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 25-30 weeks
Awards & highlights
Study Summary
This trial will study how best to sequence two interventions for parents, to improve communication and reduce disruptive behavior. #Study
Who is the study for?
This trial is for young children aged 18 to 48 months who are on the autism spectrum, as indicated by specific research criteria. They should not have other diagnoses or disabilities, must have normal vision, and be exposed to English at least half of the time. A caregiver must be willing and able to learn intervention strategies and understand conversational English.Check my eligibility
What is being tested?
The study aims to find the best order for two parent-led interventions: one that improves social communication (Project ImPACT) and another that addresses disruptive behavior (Parent Training). It will also look into factors influencing how well these treatments work.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medication, traditional side effects are not expected. However, there may be variations in individual responses to therapy sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between 25-30 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 25-30 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Caregiver Report of Child Disruptive Behavior
Caregiver Report of Child Social Communication
Family Life Impairment Scale
+2 moreSecondary outcome measures
Caregiver Perceived Stress
Caregiver Satisfaction
Trial Design
6Treatment groups
Active Control
Group I: Social Communication + Reduce FrequencyActive Control2 Interventions
Starting Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week
Secondary Intervention: "Reduce Frequency" of Social Communication Intervention Intervention: Social Communication Who: Parent & Child & Therapist Reduce Frequency: 1-hour once/week
Group II: Social Communication + Add ToolsActive Control2 Interventions
Starting Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week
Secondary Intervention: "Add Tools" to Social Communication Intervention Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week Add: Video feedback
Group III: Social Communication + Switch Intervention to Disruptive BehaviorActive Control2 Interventions
Starting Intervention: Social Communication Who: Parent & Child & Therapist Frequency: 1-hour twice/week
Secondary Intervention: Switch to Disruptive Behavior Intervention Who: Parent & Therapist only Frequency: 1-hour once/week
Group IV: Disruptive Behavior + Reduce FrequencyActive Control2 Interventions
Starting Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week
Secondary Intervention: "Reduce Frequency" of Disruptive Behavior Intervention Intervention: Disruptive Behavior Who: Parent & Therapist only Reduce Frequency: 1-hour every other week
Group V: Disruptive Behavior + Add ToolsActive Control2 Interventions
Starting Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week
Secondary Intervention: "Add Tools" to Disruptive Behavior Intervention Intervention: Disruptive Behavior Who: Parent & Therapist & Child Frequency: 1-hour once/week Add: Video feedback
Group VI: Disruptive Behavior + Switch Intervention to Social CommunicationActive Control2 Interventions
Starting Intervention: Disruptive Behavior Who: Parent & Therapist only Frequency: 1-hour once/week
Secondary Intervention: "Switch" to Social Communication Intervention Who: Parent & Child & Therapist Frequency: 1-hour twice/week
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
916,903 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
207 Patients Enrolled for Autism Spectrum Disorder
University of Texas at AustinOTHER
353 Previous Clinical Trials
81,060 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
286 Patients Enrolled for Autism Spectrum Disorder
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I want help to support my child's social skills and behavior control.My child is exposed to English more than half of the time.My child is between 1.5 and 4 years old.My child's caregiver is willing to learn how to help with their treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Social Communication + Reduce Frequency
- Group 2: Social Communication + Add Tools
- Group 3: Social Communication + Switch Intervention to Disruptive Behavior
- Group 4: Disruptive Behavior + Reduce Frequency
- Group 5: Disruptive Behavior + Add Tools
- Group 6: Disruptive Behavior + Switch Intervention to Social Communication
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial have an age limit, and if so what is it?
"Inclusion in this trial requires applicants to fall between 18 and 48 months of age. Furthermore, there are 257 trials for minors and 53 medical studies catering to elderly individuals."
Answered by AI
Is it possible for me to partake in this clinical research?
"To be accepted as a participant of this medical trial, individuals should have autism spectrum disorder and must fall between 18 months old to 48 months old. The total target recruitment is 184 persons."
Answered by AI
Is this research endeavor presently seeking participants?
"According to clinicaltrials.gov, this research trial is still recruiting participants and was initially published on June 1st 2023 with recent updates as of June 22nd 2023."
Answered by AI
Are there any potential dangers associated with Social Communication + Reduce Frequency treatments?
"Despite there being no data attesting to the efficacy of Social Communication + Reduce Frequency, pre-existing safety information yielded a score of 2 on our 1-3 scale."
Answered by AI
What is the upper limit of participants for this experiment?
"Affirmative. According to clinicaltrials.gov, this investigation into a novel therapy is currently seeking participants since it's first posting on June 1st 2023 and latest update on June 22nd 2023. This study requires 184 participants from one site of enrolment."
Answered by AI
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