ParentingBaby-NetNCT01862692
Web-based Parenting Intervention for Mothers of Infants At-Risk for Maltreatment (Baby-Net)
A study testing Baby-Net and Developmental Awareness Skills in people with Parenting, run by Oregon Research Institute at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parenting
- What is being tested?
- Baby-Net and Developmental Awareness Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, 18+ years old
- Child age 3.5-7.5 months
- Eligible for Early Head Start
- Understand spoken English or Spanish
Who cannot join
- History of severe drug use or psychopathology
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Research Institute
Eugene, Oregon, 97403
University of Kansas Center for Research
Kansas City, Kansas, 66101
About this study
Official title: Web-based Parenting Intervention for Mothers of Infants At-Risk for Maltreatment
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.
Read the detailed 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.
- Conditions
- Parenting
- Being tested
- Baby-Net, Developmental Awareness Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby-NetBehavioural
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 SkillsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Developmental Awareness Skils | Active comparator | Not described Receives: Behavioral: Developmental Awareness Skills |
| Baby-Net condition | Experimental | Not described Receives: Behavioral: Baby-Net |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post
Secondary outcomes (1)
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
Measured: 6 months (post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startAug 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ed G. Feil, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862692
- Sponsor's protocol ID
- R01HD064870
- Acronym
- Baby-Net
- Status last verified
- Sep 2015
- First submitted
- 1 May 2013
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Parenting Intervention for Mothers of Infants At-Risk for Maltreatment
- ClinicalTrials.gov ID
- NCT01862692
- Acronym / sponsor ID
- Baby-Net / R01HD064870
- Conditions
- Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Developmental Awareness Skils | Active comparator | Behavioral: Developmental Awareness Skills |
| Baby-Net condition | Experimental | Behavioral: Baby-Net |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female, 18+ years old
- Child age 3.5-7.5 months
- Eligible for Early Head Start
- Understand spoken English or Spanish
Key exclusion criteria (1 listed)
- History of severe drug use or psychopathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baby-NetParents 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. | Behavioural | Baby-Net condition |
| Developmental Awareness SkillsMothers 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. | Behavioural | Developmental Awareness Skils |
Primary outcome
The Landry Parent-Child Interaction Scales (Parent Behavior)
Time frame: 6 months post
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.
1 secondary outcome
The Landry Parent-Child Interaction Scales (Infant Behavior)
Time frame: 6 months (post)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ed G. Feil, Ph.D. principal investigator
Oregon Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby-Net and Developmental Awareness Skills in people with Parenting, run by Oregon Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Landry Parent-Child Interaction Scales (Parent Behavior) (time frame: 6 months post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.