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DivorceNCT05209932

An Internet Based Adaptation of a Divorce Intervention Beginnings Program for Divorced Parents

A study testing Online New Beginnings Program (eNBP) in people with Divorce, run by Family Transitions: Programs that Work at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Divorce
What is being tested?
Online New Beginnings Program (eNBP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
1 siteUnited States
Study dates
15 Feb 2020to 31 Aug 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Parents who do not meet all of the inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Family Transitions- Programs that Work, LLC

    Mesa, Arizona, 85209

Other trials in United States

About this study

Official title: Development and Evaluation of an Internet Based Adaptation of the New Beginnings Program for Divorced Parents

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.

Read the detailed description

This study is a two-armed intervention 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-based NBP. Three randomized controlled trials of the NBP involving over 1,800 children found positive effects to strengthen parent-child relationship quality and effective discipline and reduce children's mental health problems. The eNBP teaches all the skills in the 10-session NBP. The investigators hypothesized that parents in the eNBP would have less interparental conflict and higher parent-child relationship quality and effective discipline than those in the wait-list control condition following the intervention. The investigators also expected the children whose parents were in the eNBP would have fewer internalizing problems and externalizing problems and higher prosocial skills than those with parents in the wait-list control following the intervention.

Parents and their offspring were recruited using Qualtrics, a leading-edge sample acquisition technology that partners with 20 online panel providers and recruits nationally. Initial sampling criteria were parent was divorced, separated but never married, divorcing, or separating; had one or more children aged 6 to 18; and spoke English. Parents who met these criteria were sent an email with information about the study and a web-based survey that assessed contact with child/ren, access to a computer with high-speed internet or a smart phone and demographics. Interested parents were provided additional information about the study and screened for eligibility by phone. To be eligible, parents had to be divorced, separated but never married, divorcing or separating; have one or more child between 6 and 18; be English speaking; spend at least three hours/week or at least one overnight every other week with their child(ren); and have access to a computer with high-speed internet or a smart phone. The sample consisted of 131 parents randomized to eNBP (N = 81) or wait-list condition (N = 50) and 102 of their adolescent offspring.

Primary outcome measures were measures of interparental conflict, parent-child relationship quality, effective discipline and children's internalizing and externalizing problems and prosocial behavior.

Conditions
Divorce
Being tested
Online New Beginnings Program (eNBP)
Keywords
divorce, intervention, positive child outcomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online New Beginnings Program (eNBP)Behavioural

    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.

Study groups in NCT05209932
Study groupRoleWhat they receive
Online New Beginnings Program (eNBP)ExperimentalThe 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.
Receives: Behavioral: Online New Beginnings Program (eNBP)
wait-list control conditionNo interventionParents 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 month

  2. 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

    Measured: One month

  3. 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.

    Measured: 1 month

  4. 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.

    Measured: 1 month

  5. 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.

    Measured: 1 month

  6. 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.

    Measured: 1 month

  7. 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.

    Measured: 1 month

  8. 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.

    Measured: 1 month

  9. 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.

    Measured: 1 month

  10. 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.

    Measured: 1 month

  11. 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.

    Measured: 1 month

  12. 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.

    Measured: 1 month

  13. 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.

    Measured: 1 month

  14. 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.

    Measured: 1 month

  15. 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.

    Measured: 1 month

  16. 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.

    Measured: 1 month

  17. 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..

    Measured: 1 month

Secondary outcomes (2)
  1. Strengths and Difficulties Questionnaire -- Prosocial Subscale (Goodman, 2001) -- Parent Report Version

    5-item scale assessing child prosocial skills as reported by parents. Each of the 5 items is scored 0-2. The score reported is the mean item score. A high score is a better outcome.

    Measured: 1 month

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

    Each of the 5 items is scored 0-2 (range 0-10). The score reported is the mean of the total scores. A higher score is a better outcome.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start15 Feb 2020
  3. Primary completion15 Mar 2021
  4. Study completion31 Aug 2021

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomized to receive an online parenting program for divorced and separated parents (N=81) or a wait list control condition (N=50)
Masking
Single blind
Who is masked
Investigator
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05209932
Sponsor's protocol ID
R44HD082967
Status last verified
Dec 2022
First submitted
19 Dec 2021
Last updated
25 Jan 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Online New Beginnings Program (eNBP) in people with Divorce, run by Family Transitions: Programs that Work at 1 site 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 6 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 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 25 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Children's Perception of Interparental Conflict Scale (Grych et al., 1992) -- Children Report Version (time frame: 1 month). The study lists 17 primary outcomes in all. 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 25 Jan 2023.

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