- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05209932
An Internet Based Adaptation of a Divorce Intervention Beginnings Program for Divorced Parents
Development and Evaluation of an Internet Based Adaptation of the New Beginnings Program for Divorced Parents
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Mesa, Arizona, United States, 85209
- Family Transitions- Programs that Work, LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
* Parents who do not meet all of the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Online New Beginnings Program (eNBP)
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.
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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.
|
|
No Intervention: wait-list control condition
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Children's Perception of Interparental Conflict Scale (Grych et al., 1992) -- Children Report Version
Time Frame: 1 month
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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
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1 month
|
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Children's Perception of Interparental Conflict Scale (Grych et al., 1992) -- Parent Report Version
Time Frame: One month
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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
|
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Children's Report of Parent Behavior Inventory -- Acceptance Subscale (Shaefer, 1965) -- Parent Report Version
Time Frame: 1 month
|
16-item scales to assess parental acceptance completed by parents.
Minimum score = 1.
Maximum score = 5. High score is better outcome.
|
1 month
|
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Children's Report of Parent Behavior Inventory -- Acceptance Subscale (Shaefer, 1965) -- Child Report Version
Time Frame: 1 month
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16-item scales to assess parental acceptance completed by children.
Minimum score = 1.
Maximum score = 5. High score is better outcome.
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1 month
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Children's Report of Parent Behavior Inventory -- Rejection Subscale (Shaefer, 1965) -- Parent Report Version
Time Frame: 1 month
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16-item scales to assess parental rejection completed by parents.
Minimum score = 1.
Maximum score = 5. High score is worse outcome.
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1 month
|
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Children's Report of Parent Behavior Inventory -- Rejection Subscale (Shaefer, 1965) -- Child Report Version
Time Frame: 1 month
|
16-item scales to assess parental rejection completed by children.
Minimum score = 1.
Maximum score = 5. High score is worse outcome.
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1 month
|
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Children's Report of Parent Behavior Inventory -- Consistency Discipline Subscale (Shaefer, 1965) -- Parent Report Version
Time Frame: 1 month
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8-item scales to assess parental consistency of discipline completed by parents.
Minimum score = 1.
Maximum score = 5. High score is better outcome.
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1 month
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Children's Report of Parent Behavior Inventory -- Consistency Discipline Subscale (Shaefer, 1965) -- Child Report Version
Time Frame: 1 month
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8-item scales to assess parental consistency of discipline completed by children.
Minimum score = 1.
Maximum score = 5. High score is better outcome.
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1 month
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Oregon Discipline Scale - Follow-Through (Oregon Social Learning Center, 1991) -- Parent Report Version
Time Frame: 1 month
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11-item scales to assess parental follow-through of discipline completed by parents.
Minimum score = 1.
Maximum score = 5. High score is better outcome.
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1 month
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Oregon Discipline Scale - Follow-Through (Oregon Social Learning Center, 1991) -- Child Report Version
Time Frame: 1 month
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7-item scales to assess parental follow-through of discipline completed by children.
Minimum score = 1.
Maximum score = 5. High score is better outcome.
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1 month
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Child Monitoring Scale (Hetherington et al., 1992) -- Parent Report Version
Time Frame: 1 month
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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.
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1 month
|
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Child Monitoring Scale (Hetherington et al., 1992) -- Child Report Version
Time Frame: 1 month
|
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.
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1 month
|
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Parent Adolescent Communication Scale (Barnes & Olson, 1985) -- Parent Report
Time Frame: 1 month
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10-item scale to assess parent-child communication completed by parents.
Minimum score = 1.
Maximum score = 5. High score is better outcome.
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1 month
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Caught in the Middle Scale (Buchanan et al., 1991) -- Child Report
Time Frame: 1 month
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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.
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1 month
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Brief Problem Monitor -- Externalizing Subscale (Achenbach et al., 2011) -- Parent Report Version
Time Frame: 1 month
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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.
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1 month
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Brief Problem Monitor -- Externalizing Subscale (Achenbach et al., 2011) -- Child Report Version
Time Frame: 1 month
|
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
|
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Brief Problem Monitor -- Internalizing Subscale (Achenbach et al., 2011) -- Parent Report Version
Time Frame: 1 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strengths and Difficulties Questionnaire -- Prosocial Subscale (Goodman, 2001) -- Parent Report Version
Time Frame: 1 month
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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.
|
1 month
|
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Strengths and Difficulties Questionnaire -- Prosocial Subscale (Goodman, 2001) -- Child Report Version
Time Frame: 1 month
|
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.
|
1 month
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Collaborators and Investigators
Investigators
- Principal Investigator: Irwin N Sandler, PhD, Family Transitions Programs that Work LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R44HD082967 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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