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ATVV Intervention for Parent-Child Relationship
N/A
Waitlist Available
Led By Aleeca Bell, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Greater than or equal to 18 years old
Be older than 18 years old
Must not have
Do not speak and read English or Spanish;
Under 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test an intervention to improve mother-infant interaction for mothers who have experienced childhood adversity.
Who is the study for?
This trial is for first-time mothers over 18, expecting a single full-term and healthy baby, who have experienced childhood adversity as indicated by an ACE score of 2 or more. They must speak English or Spanish and not be taking antidepressants or illicit drugs during pregnancy.
What is being tested?
The study tests ATVV (a multisensory behavioral intervention) against standard education on safe infant care to see if it improves mother-infant interaction in women with past childhood adversity. Mothers are randomly assigned to one of the two groups and followed up from the third trimester through six months post-birth.
What are the potential side effects?
There are no direct side effects mentioned for this trial since it involves behavioral interventions rather than medications. However, any unexpected reactions related to the interventions would be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot speak or read English or Spanish.
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I am younger than 18 years old.
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I have Cystic Fibrosis.
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I have a neural tube defect.
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I am taking antidepressants while pregnant.
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I have Triple X syndrome.
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I have been diagnosed with Klinefelter syndrome.
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I have given birth to a child with conditions affecting development or the oxytocin system.
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I have Turner syndrome.
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I have trisomy 18.
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I have Down syndrome.
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I have been diagnosed with Trisomy 13.
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I have a heart defect.
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I have a musculoskeletal defect.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline at 31weeks +/- 2 weeks gestation and every 28 days +/- 7 days from birth to 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mother-Infant Synchrony, Gaze and Affect
Secondary study objectives
Mother-Infant Synchrony, Vocalization and Touch
Oxytocin
Oxytocin receptor gene DNA methylation reflecting epigenetic marks
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral ATVV interventionExperimental Treatment1 Intervention
A multi-sensory behavioral intervention that includes auditory, tactile, visual and vestibular (ATVV) stimulation contingent upon infant cues.
Group II: Attention controlActive Control1 Intervention
An attention control group that receives education on safe infant care and the same amount of attention as the intervention group.
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
539 Previous Clinical Trials
160,914 Total Patients Enrolled
Children's WisconsinUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
Aleeca Bell, PhDPrincipal InvestigatorUniversity of Arizona, College of Nursing
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant with more than one baby.I cannot speak or read English or Spanish.You are pregnant with only one baby.You are pregnant and expected to have a healthy baby.You have given birth multiple times.You have experienced at least 2 adverse events during childhood, according to the ACE survey.You are using illegal drugs.I am younger than 18 years old.You were born with a physical condition or abnormality.I have Cystic Fibrosis.You are currently pregnant.The baby inside the mother's womb is not growing properly.I have a neural tube defect.I am healthy, though I may have had gestational diabetes.I am taking antidepressants while pregnant.I have Triple X syndrome.I have been diagnosed with Klinefelter syndrome.I have given birth to a child with conditions affecting development or the oxytocin system.I have Turner syndrome.I have trisomy 18.You have hemophilia.My condition involves a genetic abnormality.I have Down syndrome.I have been diagnosed with Trisomy 13.I am 18 years old or older.I have a heart defect.I have a musculoskeletal defect.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral ATVV intervention
- Group 2: Attention control
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.