NCT00056303

Brief Summary

This study will determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2003

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

14 years

First QC Date

March 10, 2003

Last Update Submit

December 19, 2016

Conditions

Problem BehaviorsAttention Deficit Hyperactivity DisorderDepression

Keywords

AttachmentInterventionPrevention

Outcome Measures

Primary Outcomes (1)

  • Attachment

    The Preschool Strange Situation is conducted annually.

    Annually

Secondary Outcomes (2)

  • Executive Functioning

    Annually

  • Diurnal production of cortisol

    Annually

Study Arms (2)

Attachment and Biobehavioral Catch-up

EXPERIMENTAL

Attachment and Biobehavioral Catch-up targets nurturance, synchrony, and non-frightening behavior, as well as providing caregivers with help calming toddlers.

Behavioral: Attachment and Biobehavioral Catch-up

Developmental Education for Families

ACTIVE COMPARATOR

Developmental Education for Families targets providing cognitive stimulation to their children.

Behavioral: Developmental Education for Families

Interventions

Attachment and Biobehavioral Catch-upBEHAVIORAL

Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.

Attachment and Biobehavioral Catch-up
Developmental Education for FamiliesBEHAVIORAL

Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.

Developmental Education for Families

Eligibility Criteria

Age20 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Toddler placed into foster care
  • Resident of Delaware and surrounding counties in Pennsylvania and Maryland

You may not qualify if:

  • Significant medical problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

MeSH Terms

Conditions

Problem BehaviorAttention Deficit Disorder with HyperactivityDepression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild BehaviorAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mary Dozier, Ph.D.

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
UNIDEL-Amy E dupont Professor, Psychology

Study Record Dates

First Submitted

March 10, 2003

First Posted

March 11, 2003

Study Start

December 1, 2002

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 20, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)