Mental HealthNCT04980794
The Happy Families Project: Testing the Effectiveness of a Conflict Resolution Program for Families
A study testing Parent-child intervention and Self-study Intervention in people with Mental Health and Conflict, run by University of Notre Dame at 3 sites in United States.
Trial summary
This study is designed to test the effectiveness of a psychoeducation-based program to address communication and conflict resolution in families, thereby supporting mental health in children and their caregivers. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Conflict
- What is being tested?
- Parent-child intervention and Self-study Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Two parents or primary caregivers
- Child between 4 and 17 years old
- English literate
- Able/willing to participate through the 12-month follow up assessment.
Who cannot join
- Families who cannot communicate in English
- Single parent families
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Fort Wayne Center for Children and Families
Fort Wayne, Indiana, 46814
Katie Bergman, PhD, 574-631-0956, kbergman@nd.edu
- Recruiting
Indianapolis Virtual Site
Indianapolis, Indiana, 46260
Katie Bergman, PhD, 574-631-0956, kbergman@nd.edu
John G Borkowski, PhD, jborkows@nd.edu
- Recruiting
University of Notre Dame
Notre Dame, Indiana, 46556
Katie Bergman, PhD, 574-631-0956, kbergman@nd.edu
E. Mark Cummings, PhD, 574-631-0956, ecumming@nd.edu
About this study
Official title: Effectiveness of an Empirically Supported Family Intervention: Mental Health Outcomes, Mechanisms of Effect, and Organizational Factors
This study is designed to test the effectiveness of a psychoeducation-based program to address communication and conflict resolution in families, thereby supporting mental health in children and their caregivers.
Read the detailed description
The goal of the study is to evaluate the effectiveness of a program to improve mental health in families by reducing stress and supporting effective communication and conflict resolution.
Families will be randomly assigned to one of two conditions: in the self-study condition, families will receive information to review on their own, paired with regular (weekly) contact from a family coach; in the second condition, families will receive information to review on their own, regular contact from a coach, and will participate in video sessions with a family coach who will provide feedback on their interactions and coaching on their use of a communication technique. Data collection, management and analysis will be conducted by researchers at the University of Notre Dame, but the intervention will occur through community organizations in three cities in Indiana, allowing for tests of the effectiveness of the program when it is implemented in community settings. Families will participate in a pre-test assessment, a four-week intervention, a post-test assessment, and a one-year follow up assessment. Also evaluated will be organizational factors and factors that impact ultimate implementation and scalability of the program in community settings.
- Conditions
- Mental Health, Conflict
- Being tested
- Parent-child intervention, Self-study Intervention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-child interventionBehavioural
Families (two adult caregivers, child between 4 and 17) receive four interactive, asynchronous psychoeducation modules to review on their own paired with weekly contact with a communication coach and two live sessions with a communication coach to discuss psychoeducation, receive feedback on their interactions, and practice a communication technique.
Self-study InterventionBehavioural
Families (two adult caregivers) receive information in a newsletter format to review on their own, paired with weekly contact from a communication coach to answer questions and direct their attention toward specific topics in the newsletter.
| Study group | Role | What they receive |
|---|---|---|
| Parent-Child Intervention | Experimental | This is a four-dose intervention that includes psychoeducational modules and communication coaching administered through community organizations over the course of four weeks. Both participating adults and the participating child receive materials to review each week, paired with weekly contact from a family coach. Receives: Behavioral: Parent-child intervention |
| Self-study intervention | Active comparator | This is a four-dose intervention that include written self-study materials to review, paired with weekly contact with a family coach. Both participating adults receive self-study materials; the participating child does not receive separate materials. Receives: Behavioral: Self-study Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and Difficulties Questionnaire (SDQ)
Youth Adjustment
Measured: 1 year
Center for Epidemiological Studies Depression Scale (CESD)
Youth Adjustment
Measured: 1 year
Revised Children's Manifest Anxiety Scale (RCMAS)
Youth Adjustment
Measured: 1 year
Child Behavior Checklist (CBCL)
Youth Adjustment
Measured: 1 year
O'Leary Porter Scale (OPS)
Interadult Conflict
Measured: 1 year
Family Interactions Coding Scale
Observational measures of interadult and family conflict
Measured: 1 year
Security in the Marital System Questionnaire (SIMS-PR)
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
Measured: 1 year
Security in the Subsystem (SIS)
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
Measured: 1 year
Security in the Family System (SIFS)
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
Measured: 1 year
Organizational Characteristics Measure (purpose created measure of organizational characteristics)
Testing organizational factors associated with program effectiveness
Measured: 4 years
Leadership Perspective Measure (purpose created measure of organizational leaderships' perspective on program, implementation and sustainability)
Testing organizational factors associated with program effectiveness
Measured: 4 years
Facilitator Perspective Measure (purpose created measure of community facilitators' perspective on program implementation and training)
Testing organizational factors associated with program effectiveness
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Mar 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Model description
- Participants are randomly assigned to one of two conditions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980794
- Sponsor's protocol ID
- 20-0852
- Status last verified
- Nov 2024
- First submitted
- 13 Jul 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Empirically Supported Family Intervention: Mental Health Outcomes, Mechanisms of Effect, and Organizational Factors
- ClinicalTrials.gov ID
- NCT04980794
- Acronym / sponsor ID
- 20-0852
- Conditions
- Mental Health, Conflict
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Jul 2021 (actual)
- 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 study is designed to test the effectiveness of a psychoeducation-based program to address communication and conflict resolution in families, thereby supporting mental health in children and their caregivers.
Detailed description
The goal of the study is to evaluate the effectiveness of a program to improve mental health in families by reducing stress and supporting effective communication and conflict resolution.
Families will be randomly assigned to one of two conditions: in the self-study condition, families will receive information to review on their own, paired with regular (weekly) contact from a family coach; in the second condition, families will receive information to review on their own, regular contact from a coach, and will participate in video sessions with a family coach who will provide feedback on their interactions and coaching on their use of a communication technique. Data collection, management and analysis will be conducted by researchers at the University of Notre Dame, but the intervention will occur through community organizations in three cities in Indiana, allowing for tests of the effectiveness of the program when it is implemented in community settings. Families will participate in a pre-test assessment, a four-week intervention, a post-test assessment, and a one-year follow up assessment. Also evaluated will be organizational factors and factors that impact ultimate implementation and scalability of the program in community settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two conditions.
| Arm | Type | Receives |
|---|---|---|
| Parent-Child Intervention | Experimental | Behavioral: Parent-child interventionThis is a four-dose intervention that includes psychoeducational modules and communication coaching administered through community organizations over the course of four weeks. Both participating adults and the participating child receive materials to review each week, paired with weekly contact from a family coach. |
| Self-study intervention | Active comparator | Behavioral: Self-study InterventionThis is a four-dose intervention that include written self-study materials to review, paired with weekly contact with a family coach. Both participating adults receive self-study materials; the participating child does not receive separate materials. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Two parents or primary caregivers
- Child between 4 and 17 years old
- English literate
- Able/willing to participate through the 12-month follow up assessment.
Key exclusion criteria (2 listed)
- Families who cannot communicate in English
- Single parent families
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 |
|---|---|---|
| Parent-child interventionFamilies (two adult caregivers, child between 4 and 17) receive four interactive, asynchronous psychoeducation modules to review on their own paired with weekly contact with a communication coach and two live sessions with a communication coach to discuss psychoeducation, receive feedback on their interactions, and practice a communication technique. | Behavioural | Parent-Child Intervention |
| Self-study InterventionFamilies (two adult caregivers) receive information in a newsletter format to review on their own, paired with weekly contact from a communication coach to answer questions and direct their attention toward specific topics in the newsletter. | Behavioural | Self-study intervention |
Primary outcome
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 1 year
Youth Adjustment
Center for Epidemiological Studies Depression Scale (CESD)
Time frame: 1 year
Youth Adjustment
Revised Children's Manifest Anxiety Scale (RCMAS)
Time frame: 1 year
Youth Adjustment
Child Behavior Checklist (CBCL)
Time frame: 1 year
Youth Adjustment
O'Leary Porter Scale (OPS)
Time frame: 1 year
Interadult Conflict
Family Interactions Coding Scale
Time frame: 1 year
Observational measures of interadult and family conflict
Security in the Marital System Questionnaire (SIMS-PR)
Time frame: 1 year
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
Security in the Subsystem (SIS)
Time frame: 1 year
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
Security in the Family System (SIFS)
Time frame: 1 year
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
Organizational Characteristics Measure (purpose created measure of organizational characteristics)
Time frame: 4 years
Testing organizational factors associated with program effectiveness
Leadership Perspective Measure (purpose created measure of organizational leaderships' perspective on program, implementation and sustainability)
Time frame: 4 years
Testing organizational factors associated with program effectiveness
Facilitator Perspective Measure (purpose created measure of community facilitators' perspective on program implementation and training)
Time frame: 4 years
Testing organizational factors associated with program effectiveness
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-child intervention and Self-study Intervention in people with Mental Health and Conflict, run by University of Notre Dame at 3 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 2 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: looking for participants now, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie N Bergman, PhD (574-631-0956, kbergman@nd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Difficulties Questionnaire (SDQ) (time frame: 1 year). The study lists 12 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 15 Nov 2024.