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Behavioral Intervention

Attachment-Based Intervention for Child Health Outcomes

N/A

Recruiting

Led By Lisa Berlin, PhD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Must not have

Children who have major complex medical conditions (e.g., heart or autoimmune conditions) that could interfere with participation in intervention sessions and/or research assessments

Children born prematurely (gestational age < 37 weeks)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this data will be gathered at time 3 (24 months).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if an attachment-based intervention can help improve health outcomes in low-income Latino kids (ages 9mo-5 yrs). It compares two programs to see which works best.

Who is the study for?

This trial is for Latina mothers with a 9-month-old child enrolled in Medicaid. The child must be born at full term without major complex medical conditions like heart or autoimmune diseases that could affect participation.

What is being tested?

The study tests an attachment-based intervention (ABC) against a Home Book-of-the-Week program, focusing on health outcomes such as illnesses, body mass index, and sleep in low-income Latino children.

What are the potential side effects?

Since the interventions are non-medical (parenting programs), they do not have typical side effects like drugs; however, there may be indirect impacts on family dynamics or stress levels.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child has a serious health condition that could affect their participation in the study.

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I was born before 37 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this data will be gathered at time 3 (24 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this data will be gathered at time 3 (24 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and this data will be gathered at time 3 (24 months). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Mass Index

Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)

Expressive Speech Delay

+9 more

Other study objectives

Child Stress Regulation: Age 15 months

Child Stress Regulation: Age 9 months

Child Stress Regulation: At 15 months

+3 more

Awards & 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: Attachment and Biobehavioral Catch-up (ABC) programExperimental Treatment1 Intervention

The ABC program consists of 10 1 -hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic.

Group II: Home-Based Book-of-the-Week (HBOW) programActive Control1 Intervention

The HBOW program consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. A trained RA will utilize a standard set of questions to ask about the mother's and child's well-being.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Attachment and Biobehavioral Catch-Up

2013

N/A

~50

0 / 2Eligibility criteria met