Web-based Parenting Intervention for Mothers of Infants At-Risk for Maltreatment (Baby-Net)

Parenting Clinical Trial

— Baby-Net  

Official title:

Web-based Parenting Intervention for Mothers of Infants At-Risk for Maltreatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862692
• Other study ID #: R01HD064870
• Status: Completed
• Phase: N/A
• First received: May 1, 2013
• Last updated: September 29, 2015
• Start date: August 2011
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

Parents of infants living in poverty are at significantly elevated risk of a host of detrimental outcomes, including the development of child behavior problems, neglect and abuse of children, child learning problems and parental substance abuse. Research has found that early interventions to improve parenting practices were effective to ameliorate these outcomes. Yet, there exist major obstacles to the effective delivery of mental health services, particularly in rural areas. The need of rural families for mental health services is reaching crisis proportions due to the dearth of trained professionals. In addition, the meteoric rise of Internet use has created a new avenue for people to communicate and share ideas. These two trends are helping fuel the demand for mental health services and on-line support.

Internet programs can be interactive and provide social support from peers and professionals. Through the use of recent advances in multimedia technology and software as well as the rise of computer networking via the Internet, there now exists an opportunity to provide such monitoring of outcomes and remote contact for rural locations. Prior developmental R34 research ("Infant Net") successfully adapted and pilot tested an existing empirically proven parenting program, for delivery via the Internet, enhanced with weekly professional contact. This research provided 40 mothers of infants 3.5 to 7 months (at enrollment) with a computer, computer camera, Internet connection, and technical training/support for 6 months to evaluate the digital translation. Mother-infant dyads were randomized to Experimental or Computer/Control conditions. Results found significant change with infant-behavioral and positive trends were demonstrated in parenting behaviors. Mothers rated the both computer program and interaction with coaches to be very high. These encouraging developmental research results provide a very good empirical base for a fully powered randomized control trial to test effectiveness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female, 18+ years old

• Child age 3.5-7.5 months

• Eligible for Early Head Start

• Understand spoken English or Spanish

Exclusion Criteria:

• History of severe drug use or psychopathology

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parenting

Intervention

Behavioral:
• Baby-Net
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.
• Developmental Awareness Skills
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.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon
United States	University of Kansas Center for Research	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The Landry Parent-Child Interaction Scales (Infant Behavior)	The Landry Parent-Child Interaction Scales, relative to directly observed maternal behavior, will also be used to assess infant functioning. Rating scales of interest in this regard are those assessing the infant behaviors of attention/arousal, warmth-seeking, and behavioral regulation. Ratings of infant behavior will be completed on the same mother-infant observational assessments as those used to assess maternal behavior at pre- and post-intervention	6 months (post)	No