NCT01862692

Brief Summary

This innovative interactive Internet-based parent education intervention will help serve to promote the social emotional development and communication skills of infants to decrease the chances of child maltreatment in low-income, culturally diverse, families.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

August 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

4 years

First QC Date

May 1, 2013

Last Update Submit

September 29, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Landry Parent-Child Interaction Scales (Parent Behavior)

    The Landry Scales are designed to assess naturalistic parent-child interaction. The parent scales of interest in the current study relative to maternal responsiveness include ratings of maternal positive affect, warmth, flexibility, and positive verbal content. Relative to maternal negative behavior, scales of interest include ratings of maternal physical intrusiveness as well as verbal and affective negativity.

    6 months post

Secondary Outcomes (1)

  • The Landry Parent-Child Interaction Scales (Infant Behavior)

    6 months (post)

Study Arms (2)

Developmental Awareness Skils

ACTIVE COMPARATOR
Behavioral: Developmental Awareness Skills

Baby-Net condition

EXPERIMENTAL
Behavioral: Baby-Net

Interventions

Baby-NetBEHAVIORAL

Parents randomized to the intervention condition will receive a computerized adaptation of the empirically supported PALS parenting program as well as a laptop and wireless Internet connection. In this study, we adapted original 10-session PALS program for computer administration and included a session on reading (Read to Me, Inc.; http://www.readtomeprogram.org/index.html), developed to be incorporated within the PALS program. Each session includes the following: (a) a presentation of concepts, behaviors, and examples, (b) check-in questions recorded to the data base for review by both parent and coach, (c) the creation of a 5 minute computer-collected video of mother-infant interactions for later review by coach and parent, (d) a summary of topics, (e) daily activities (homework), (f) feedback about the program recorded to the database and (g) a weekly telephone coach call to review mother-infant computer-administered video and session topics and skills.

Baby-Net condition

Mothers in this condition will receive weekly phone contact with a coach as well as a laptop and wireless Internet connection. The laptop will contain a computer-based infant intervention program that is structurally similar to the Infant Program in terms of components (e.g., information pages, mother-infant video recording pages; coach contact pages), however weekly information will focus on their infants' development, with no direct maternal skills instruction. Mothers in this condition will receive the same number of contacts with the computer and coach as mothers in the InfantNet condition and will participate in weekly phone calls with a coach. During phone calls, parents will co-view weekly mother-infant video with their coach, with mothers having been instructed to play with their infant (with no prescribed tasks to perform) and the discussion will focus on general infant development.

Developmental Awareness Skils

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, 18+ years old
  • Child age 3.5-7.5 months
  • Eligible for Early Head Start
  • Understand spoken English or Spanish

You may not qualify if:

  • History of severe drug use or psychopathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Center for Research

Kansas City, Kansas, 66101, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Study Officials

  • Ed G. Feil, Ph.D.

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2013

First Posted

May 24, 2013

Study Start

August 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations