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Behavioral Intervention

Early Intervention Programs for Parenting Neglected Children

Phase 1 & 2

Waitlist Available

Led By Mary Dozier, Ph.D.

Research Sponsored by University of Delaware

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

must have been in earlier randomized clinical trial

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up child age of 10 years

Awards & highlights

Study Summary

This trial will compare the outcomes of two groups of neglecting parents, one of which received an intervention in infancy. It is expected that the intervention group will be more nurturing and follow their children's lead more, and that the children will have better outcomes in various areas than the control group.

Who is the study for?

This trial is for children who have been diagnosed with Conduct Disorder, ADHD, or Depression and were part of an earlier clinical trial. It focuses on the long-term effects of a parenting intervention given during infancy.Check my eligibility

What is being tested?

The study tests if early childhood interventions like Developmental Education for Families and Attachment and Biobehavioral Catch-up can lead to better nurturing by parents and improved child outcomes in areas such as attachment, self-control, emotion management, and social interactions.See study design

What are the potential side effects?

Since this trial involves educational and behavioral interventions rather than medications, traditional side effects are not expected. However, there may be emotional or psychological impacts from participating in the therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ child age of 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~child age of 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and child age of 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Attachment

Child aggression

Child diagnosis

+4 more

Secondary outcome measures

Alpha and theta wave

Autonomic nervous system activity

Body mass index

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Attachment and Biobehavioral Catch-upExperimental Treatment1 Intervention

Attachment and Biobehavioral Catch-up - 10 session intervention to enhance nurturance and following the lead

Group II: Developmental Education for FamiliesActive Control1 Intervention

Developmental Education for Families - 10 session intervention that targets cognitive development

Group III: Low-riskActive Control1 Intervention

Low-risk comparison group

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Attachment and Biobehavioral Catch-up

2002

Completed Phase 1

~440

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of DelawareLead Sponsor

154 Previous Clinical Trials

24,991 Total Patients Enrolled

1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

220 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Mary Dozier, Ph.D.Principal InvestigatorUniversity of Delaware

4 Previous Clinical Trials

760 Total Patients Enrolled

1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

220 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Attachment and Biobehavioral Catch-up (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02093052 — Phase 1 & 2

Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Developmental Education for Families, Low-risk, Attachment and Biobehavioral Catch-up

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Attachment and Biobehavioral Catch-up Highlights & Side Effects. Trial Name: NCT02093052 — Phase 1 & 2

Attachment and Biobehavioral Catch-up (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02093052 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial limited to persons over a certain age, or can individuals of all ages participate?

"As per the study's requirements, only children aged 6 to 8 can participate."

Answered by AI

What is the primary focus of this research endeavor?

"This clinical trial will span 36 months and is designed to track changes in Child aggression. The secondary goals are Autonomic nervous system activity (Respiratory Sinus Arrhythmia), brain activation as observed through fMRI, and Play group interactions which will be analyzed for indices of peer rejection."

Answered by AI

Is this trial still accepting new participants?

"According to clinicaltrials.gov, this research is not currently accepting participants. It was first posted on March 1st 2005 and last updated November 14th 2020. Despite this, 1271 other studies are actively seeking volunteers right now."

Answered by AI

Who has the opportunity to participate in this research?

"This trial is recruiting 220 minors aged 6 and 8, who suffer from conduct disorder. Critically, prospects should have participated in a previous randomized clinical experiment."

Answered by AI

Recent research and studies

PsychoneuroendocrinologyJournal

Parental Sensitivity Mediates the Sustained Effect of Attachment and Biobehavioral Catch-up on Cortisol in Middle Childhood: A Randomized Clinical Trial

Garnett, Mallory, Kristin Bernard, Julie Hoye, Lindsay Zajac, and Mary Dozier. 2020. “Parental Sensitivity Mediates the Sustained Effect of Attachment and Biobehavioral Catch-up on Cortisol in Middle Childhood: A Randomized Clinical Trial”. Psychoneuroendocrinology. Elsevier BV. doi:10.1016/j.psyneuen.2020.104809.

American Journal of PsychiatryJournal

Early Parenting Intervention Effects on Brain Responses to Maternal Cues Among High-risk Children

Valadez, Emilio A., Nim Tottenham, Alexandra R. Tabachnick, and Mary Dozier. 2020. “Early Parenting Intervention Effects on Brain Responses to Maternal Cues Among High-risk Children”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/appi.ajp.2020.20010011.

Journal of Child Psychology and PsychiatryJournal

Sustained Effects on Attachment Security in Middle Childhood: Results from a Randomized Clinical Trial of the Attachment and Biobehavioral Catch‐up (ABC) Intervention

Zajac, Lindsay, K. Lee Raby, and Mary Dozier. 2019. “Sustained Effects on Attachment Security in Middle Childhood: Results from a Randomized Clinical Trial of the Attachment and Biobehavioral Catch‐up (ABC) Intervention”. Journal of Child Psychology and Psychiatry. Wiley. doi:10.1111/jcpp.13146.

Pediatric ObesityJournal