NCT05209932

Brief Summary

This study is a two-armed randomized controlled trial of the eNew Beginnings Program (eNBP)'s effects on children's mental health problems as well as interparental conflict, parent-child relationship quality and effective discipline. The eNBP is an asynchronous, fully web-based program that was based on the in-person, group NBP, which has been found to strengthen parent-child relationship quality and effective discipline and reduce children's mental health problems in three randomized controlled trials of the NBP involving over 1,800 children. The investigators hypothesized that parents in the eNBP intervention condition would have less interparental conflict and higher parent-child relationship quality and effective discipline than those in the wait-list control condition. The investigators also expected the children whose parents were in the eNBP intervention condition would have fewer internalizing problems and externalizing problems and higher prosocial skills than those with parents in the wait-list control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 25, 2023

Completed
Last Updated

January 25, 2023

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

December 19, 2021

Results QC Date

June 15, 2022

Last Update Submit

December 27, 2022

Conditions

Keywords

divorceinterventionpositive child outcomes

Outcome Measures

Primary Outcomes (17)

  • Children's Perception of Interparental Conflict Scale (Grych et al., 1992) -- Children Report Version

    15-item scale assessing frequency and intensity of interparental conflict as reported by children. Minimum score = 1; Maximum score = 3. High score is worse outcome

    1 month

  • Children's Perception of Interparental Conflict Scale (Grych et al., 1992) -- Parent Report Version

    15-item scale assessing frequency and intensity of interparental conflict as reported by parents. Minimum score = 1; Maximum score = 3. High score is worse outcome

    One month

  • Children's Report of Parent Behavior Inventory -- Acceptance Subscale (Shaefer, 1965) -- Parent Report Version

    16-item scales to assess parental acceptance completed by parents. Minimum score = 1. Maximum score = 5. High score is better outcome.

    1 month

  • Children's Report of Parent Behavior Inventory -- Acceptance Subscale (Shaefer, 1965) -- Child Report Version

    16-item scales to assess parental acceptance completed by children. Minimum score = 1. Maximum score = 5. High score is better outcome.

    1 month

  • Children's Report of Parent Behavior Inventory -- Rejection Subscale (Shaefer, 1965) -- Parent Report Version

    16-item scales to assess parental rejection completed by parents. Minimum score = 1. Maximum score = 5. High score is worse outcome.

    1 month

  • Children's Report of Parent Behavior Inventory -- Rejection Subscale (Shaefer, 1965) -- Child Report Version

    16-item scales to assess parental rejection completed by children. Minimum score = 1. Maximum score = 5. High score is worse outcome.

    1 month

  • Children's Report of Parent Behavior Inventory -- Consistency Discipline Subscale (Shaefer, 1965) -- Parent Report Version

    8-item scales to assess parental consistency of discipline completed by parents. Minimum score = 1. Maximum score = 5. High score is better outcome.

    1 month

  • Children's Report of Parent Behavior Inventory -- Consistency Discipline Subscale (Shaefer, 1965) -- Child Report Version

    8-item scales to assess parental consistency of discipline completed by children. Minimum score = 1. Maximum score = 5. High score is better outcome.

    1 month

  • Oregon Discipline Scale - Follow-Through (Oregon Social Learning Center, 1991) -- Parent Report Version

    11-item scales to assess parental follow-through of discipline completed by parents. Minimum score = 1. Maximum score = 5. High score is better outcome.

    1 month

  • Oregon Discipline Scale - Follow-Through (Oregon Social Learning Center, 1991) -- Child Report Version

    7-item scales to assess parental follow-through of discipline completed by children. Minimum score = 1. Maximum score = 5. High score is better outcome.

    1 month

  • Child Monitoring Scale (Hetherington et al., 1992) -- Parent Report Version

    9-item scales to assess parental monitoring of child behaviors with friends and at school completed by parents. Minimum score = 1. Maximum score = 5. High score is better outcome.

    1 month

  • Child Monitoring Scale (Hetherington et al., 1992) -- Child Report Version

    9-item scales to assess parental monitoring of child behaviors with friends and at school completed by children. Minimum score = 1. Maximum score = 5. High score is better outcome.

    1 month

  • Parent Adolescent Communication Scale (Barnes & Olson, 1985) -- Parent Report

    10-item scale to assess parent-child communication completed by parents. Minimum score = 1. Maximum score = 5. High score is better outcome.

    1 month

  • Caught in the Middle Scale (Buchanan et al., 1991) -- Child Report

    7-item scales to assess children being caught in the middle between parents completed by children. Minimum score = 1. Maximum score = 4. High score is worse outcome.

    1 month

  • Brief Problem Monitor -- Externalizing Subscale (Achenbach et al., 2011) -- Parent Report Version

    7-item scale assessing child externalizing problems as reported by parents. The sum score of the items (range 0-2 for each item) for each individual is converted to T-score, using the algorithm purchased from ASEBA (Achenbach System of Empirically Based Assessment). The range of the T-scores is: 0 (minimum) to 100 (maximum). High score is worse outcome.

    1 month

  • Brief Problem Monitor -- Externalizing Subscale (Achenbach et al., 2011) -- Child Report Version

    7-item scale assessing child externalizing problems as reported by children. Item scores range from 0-2, a sum score across the items was computed and converted to a T-score using the algorithm purchased from ASEBA (Achenbach System of Empirically Based Assessment). The range of the T-scores is: 0 (minimum) to 100 (maximum). Score of 50 = the fiftieth percentile of the normative sample. (Achenbach \& Rescola, 2001). T-scores of 65 and above are considered sufficiently elevated to be of concern. The values shown are the T-score values for the sample. Higher scores indicate a worse outcome.

    1 month

  • Brief Problem Monitor -- Internalizing Subscale (Achenbach et al., 2011) -- Parent Report Version

    6-item scale assessing child internalizing problems as reported by parents. Item scores range from 0-2, a sum score across the items was computed and converted to a T-score using the algorithm purchased from ASEBA (Achenbach System of Empirically Based Assessment). The range of the T-scores is: 0 (minimum) to 100 (maximum). Score of 50 = the fiftieth percentile of the normative sample. (Achenbach \& Rescola, 2001). T-scores of 65 and above are considered sufficiently elevated to be of concern. The values shown are the T-score values for the sample. Higher scores indicate a worse outcome..

    1 month

Secondary Outcomes (2)

  • Strengths and Difficulties Questionnaire -- Prosocial Subscale (Goodman, 2001) -- Parent Report Version

    1 month

  • Strengths and Difficulties Questionnaire -- Prosocial Subscale (Goodman, 2001) -- Child Report Version

    1 month

Study Arms (2)

Online New Beginnings Program (eNBP)

EXPERIMENTAL

The eNBP is a five-hour, asynchronous, fully web-based adaptation of the group NBP. Separate versions for fathers and mothers consist of the same didactic content and interactive exercises, with gender appropriate references, testimonials and video skills demonstrations. Units are highly interactive. Sessions began with a check-in in which parents responded to questions about use of the program skills and were provided with ways to address the challenges they experienced. The skill was then taught using modeling videos, interactive exercises, and testimonials from prior participants. The program then prompted parents to set times to use the skill, identify barriers to using it and select strategies to reduce these barriers. Parents were provided with tip sheets to address challenges in using the skill, downloadable sheets to record use of and competence in using the skill and a downloadable handbook that summarized what was covered in the unit.

Behavioral: Online New Beginnings Program (eNBP)

wait-list control condition

NO INTERVENTION

Parents in the waitlist-control condition were told that they would have access to the eNBP 12 weeks after they completed the pre-test. Twelve weeks after assignment to condition, parents and children were sent links to the posttest

Interventions

The eNBP is a five-hour, asynchronous, fully web-based adaptation of the group-based NBP that can be used on a smart phone, tablet or computer. Separate versions for fathers and mothers consist of the same didactic content and interactive exercises, with gender appropriate references, testimonials and video skills demonstrations.

Online New Beginnings Program (eNBP)

Eligibility Criteria

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

You may qualify if:

  • Parents divorced, divorcing or separated
  • Parents separated but never married
  • One or more children aged 6 to 18
  • Parents spoke English
  • Parents spend at least 3 hours a week with children or have one overnight every other week with their children
  • Parents have access to a computer with high speed internet access of a smart phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Transitions- Programs that Work, LLC

Mesa, Arizona, 85209, United States

Location

Limitations and Caveats

Limitations are that only pre and post assessment was completed with no follow-up over time.

Results Point of Contact

Title
Michele M Porter, PhD - Co-PI/Partner
Organization
Family Transitions - PTW, LLC

Study Officials

  • Irwin N Sandler, PhD

    Family Transitions Programs that Work LLC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigators were not aware of whether the participants were assigned to eNBP or the wait-list control condition.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomized to receive an online parenting program for divorced and separated parents (N=81) or a wait list control condition (N=50)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2021

First Posted

January 27, 2022

Study Start

February 15, 2020

Primary Completion

March 15, 2021

Study Completion

August 31, 2021

Last Updated

January 25, 2023

Results First Posted

January 25, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

Data Sharing Plan Results from research conducted under this project will be shared in several ways. Manuscripts will be submitted for publication in high-quality peer-reviewed journals, following the NIH Public Access Policy guidelines. Findings will be presented at relevant national conferences for groups such as Association of Family Courts and Conciliators (AFCC), and Society for Prevention Research (SPR). We will also share the deidentified data with other researchers when requested.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
January 2022 - no end date
Access Criteria
Contact Study Co-I/PD - Dr. Michele Porter at m.marie.porter@gmail.com Or through the contact us on the company website.
More information

Locations