Violence in AdolescenceETHRNCT05880979
Engaging Together for Healthy Relationships
A study testing Engaging Together for Healthy Relationships and Regular well child care in people with Violence in Adolescence and Domestic Violence, run by University of Pittsburgh at 2 sites in United States.
Trial summary
The goal of this pilot randomized clinical trial is to assess feasibility and acceptability of a brief parent-adolescent dating violence prevention intervention (Engaging Together for Healthy Relationships; ETHR) delivered in pediatric primary care settings. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Violence in Adolescence, Domestic Violence
- What is being tested?
- Engaging Together for Healthy Relationships and Regular well child care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2023to 1 Dec 2024
- 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Providers:
- Sees patient at an eligible primary care clinic
- Speaks and understands English
- Age 18 or older
- Identifies as a pediatrician, nurse practitioner, physician assistant (pediatric primary care healthcare provider)
- Adolescents
Show all 16Show fewer
- Age 11 to 15
- Attending an upcoming well-child visit from a provider enrolled in the study
- Caregiver who is accompanying well-child visit with adolescent is also participating
- Speaks and understands English
- Parents
- Is parent or primary caregiver for an adolescent age 11 to 15
- Adolescent has an upcoming well-child visit with a provider enrolled in the study
- Accompanying child to the well-visit
- Adolescent is interested and eligible to participate in study
- Speaks and understand English
Who cannot join
- Providers
- 1) Does not need inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CCP South Hills
Monongahela, Pennsylvania, 15063
Primary Care Center Oakland
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Engaging Together for Healthy Relationships: A Pilot Trial to Test a Brief Dating Violence Prevention Intervention for Pediatric Primary Care
The goal of this pilot randomized clinical trial is to assess feasibility and acceptability of a brief parent-adolescent dating violence prevention intervention (Engaging Together for Healthy Relationships; ETHR) delivered in pediatric primary care settings. The main questions it aims to answer is if ETHR is acceptable and feasible. 4 healthcare providers will receive ETHR to share with their patients which includes clinician training, provider-delivered scripts, resource guides, and a comprehensive website. This will be compared to providers conducting routine well-child care with their patients.
Read the detailed description
The investigators are conducting a pilot randomized clinical trial to test a brief parent-adolescent dating violence prevention intervention (Engaging Together for Healthy Relationships; ETHR). ETHR has been developed for parents and adolescents, to be implemented within pediatric primary care settings. ETHR is a comprehensive intervention which includes a training for clinicians, brief educational scripts for providers, resource guides for the adolescent, parent, and dyad, a comprehensive website, and warm referral processes to connect families with local resources. The investigators will be comparing ETHR with routine care. The specific goal of the pilot trial is to test trial feasibility, as well as intervention acceptability and fidelity. The investigators also will be examining exploratory changes in secondary outcomes and early implementation barriers and facilitators.
Four pediatric clinics will participate in this study. The investigator will recruit two providers from each clinic and randomize them into the intervention provider or control provider. The intervention provider will receive ETHR and the control provider will complete their regular well-child care. The investigators will enroll 15 families in the intervention arm and 5 in the control arm (3:1 enrollment). Families who are seeing the intervention provider for a well-child visit will be enrolled in the intervention arm; those seeing the control provider will be enrolled in the control arm. Families will be eligible if they are seeing the intervention or control providers for a well child visit, if the adolescent coming for the well-visit is between 11 to 15, if both the caregiver and adolescent are interested in participating, and if the family speaks and understands English. Families will be called 2 weeks ahead of their visit to enroll, consent, and complete a baseline survey (both the adolescent and parent will complete the survey). Participants will then attend their well -visit (where they will receive ETHR or routine care, depending on their provider). They will complete an acceptability and fidelity survey immediately post-visit, a resource utilization survey 1 month post visit, and a follow up survey (identical to the baseline survey) 3 months post visit. Providers will complete a brief fidelity and acceptability survey after each study visit (15 for intervention providers, 5 for control providers). All providers and a subset of families enrolled in the intervention arm (20 dyads, 40 participants) will also complete post-intervention interviews.
- Conditions
- Violence in Adolescence, Domestic Violence
- Being tested
- Engaging Together for Healthy Relationships, Regular well child care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engaging Together for Healthy RelationshipsBehavioural
A comprehensive parent-adolescent dating violence prevention intervention designed to be provider delivered within the context of a pediatric well-child visit
Regular well child careBehavioural
Participants will receive their regularly scheduled well-child care
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Engaging Together for Healthy Relationships) | Experimental | Providers and families in the intervention arm will receive the ETHR program which includes a clinician training, provider scripts, resource guides, a comprehensive website, and warm referral processes. Receives: Behavioral: Engaging Together for Healthy Relationships |
| Control (Receipt of regular well-child care) | Active comparator | Providers and families in the control arm will receive regular well-child care. All providers in the control arm will have access to ETHR after the pilot trial is over Receives: Behavioral: Regular well child care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who are eligible out of the total who are approached
Will assess through tracking data
Measured: Through completion of study recruitment, an average of 6 months
Percentage of participants who are consented out of the total who are eligible
Will assess through tracking data
Measured: Through completion of study recruitment, an average of 6 months
Percentage of participants who complete the baseline survey out of the total who consented
Will assess through tracking data
Measured: Through completion of completing baseline surveys, an average of 6 months
Percentage of participants who complete the well-visit out of the total who consented
Will assess through tracking data
Measured: Through completion of completing well-visits, an average of 6 months
Percentage of participants who complete the immediate post-intervention survey out of the total who consented
Will assess through tracking data
Measured: Through completion of completing post-intervention survey, an average of 7 months
Percentage of participants who complete the 1-month post-intervention survey out of the total who consented
Through completion of completing 1- month post-intervention survey, an average of 8 months
Measured: 4 months
Percentage of participants who complete the 3-month post-intervention survey out of the total who consented
Will assess through tracking data
Measured: Through completion of completing 3 month post-intervention survey, an average of 12 months
Percentage of participants who strongly agree or agree that the intervention is acceptable using a 4-item validated measure (Acceptability of Intervention Measure)
Validated measure (Acceptability of Intervention Measure)
Measured: Through completion of completing immediate post-visit surveys, an average of 6 months
Secondary outcomes (6)
Self-efficacy in preventing adolescent relationship abuse (ARA), change in outcome between baseline and 3 months
Self-efficacy around ARA prevention, 1-5 scale (5=higher self-efficacy)
Measured: Baseline, 3-month post intervention
Percentage of participants who utilize ARA resources at each measurement point, change in outcome over time
Investigator developed measure (yes/no)
Measured: Baseline, 1 month post intervention, 3 month post-intervention
Attitudes about ARA, change in outcome between baseline and 3 months
Attitudes about Abusive Relationships, 1-5 scale (1=not abusive, 5=very abusive)
Measured: Baseline, 3-month post intervention
Parent-adolescent communication around dating and ARA, change in outcome over time
Investigator developed measure, yes/no answer choices (yes=has communicated, no=has not communicated)
Measured: Baseline, 3-month post intervention
Parental monitoring around dating and ARA, change in outcome over time
Parenting Practices Scale (never to always; 1=never, 5=always)
Measured: Baseline, 3-month post intervention
Percentage of adolescents reporting ARA victimization and perpetration
CADRI Short Form 1-5 scale (never to everyday)
Measured: Baseline, 3-month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Jul 2023
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence in AdolescenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will occur at the provider-level
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Ragavan, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880979
- Sponsor's protocol ID
- STUDY22060047
- Acronym
- ETHR
- Status last verified
- Feb 2025
- First submitted
- 12 May 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Together for Healthy Relationships: A Pilot Trial to Test a Brief Dating Violence Prevention Intervention for Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT05880979
- Acronym / sponsor ID
- ETHR / STUDY22060047
- Conditions
- Violence in Adolescence, Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 30 May 2023 (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.
The goal of this pilot randomized clinical trial is to assess feasibility and acceptability of a brief parent-adolescent dating violence prevention intervention (Engaging Together for Healthy Relationships; ETHR) delivered in pediatric primary care settings. The main questions it aims to answer is if ETHR is acceptable and feasible. 4 healthcare providers will receive ETHR to share with their patients which includes clinician training, provider-delivered scripts, resource guides, and a comprehensive website. This will be compared to providers conducting routine well-child care with their patients.
Detailed description
The investigators are conducting a pilot randomized clinical trial to test a brief parent-adolescent dating violence prevention intervention (Engaging Together for Healthy Relationships; ETHR). ETHR has been developed for parents and adolescents, to be implemented within pediatric primary care settings. ETHR is a comprehensive intervention which includes a training for clinicians, brief educational scripts for providers, resource guides for the adolescent, parent, and dyad, a comprehensive website, and warm referral processes to connect families with local resources. The investigators will be comparing ETHR with routine care. The specific goal of the pilot trial is to test trial feasibility, as well as intervention acceptability and fidelity. The investigators also will be examining exploratory changes in secondary outcomes and early implementation barriers and facilitators.
Four pediatric clinics will participate in this study. The investigator will recruit two providers from each clinic and randomize them into the intervention provider or control provider. The intervention provider will receive ETHR and the control provider will complete their regular well-child care. The investigators will enroll 15 families in the intervention arm and 5 in the control arm (3:1 enrollment). Families who are seeing the intervention provider for a well-child visit will be enrolled in the intervention arm; those seeing the control provider will be enrolled in the control arm. Families will be eligible if they are seeing the intervention or control providers for a well child visit, if the adolescent coming for the well-visit is between 11 to 15, if both the caregiver and adolescent are interested in participating, and if the family speaks and understands English. Families will be called 2 weeks ahead of their visit to enroll, consent, and complete a baseline survey (both the adolescent and parent will complete the survey). Participants will then attend their well -visit (where they will receive ETHR or routine care, depending on their provider). They will complete an acceptability and fidelity survey immediately post-visit, a resource utilization survey 1 month post visit, and a follow up survey (identical to the baseline survey) 3 months post visit. Providers will complete a brief fidelity and acceptability survey after each study visit (15 for intervention providers, 5 for control providers). All providers and a subset of families enrolled in the intervention arm (20 dyads, 40 participants) will also complete post-intervention interviews.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomization will occur at the provider-level
| Arm | Type | Receives |
|---|---|---|
| Intervention (Engaging Together for Healthy Relationships) | Experimental | Behavioral: Engaging Together for Healthy RelationshipsProviders and families in the intervention arm will receive the ETHR program which includes a clinician training, provider scripts, resource guides, a comprehensive website, and warm referral processes. |
| Control (Receipt of regular well-child care) | Active comparator | Behavioral: Regular well child careProviders and families in the control arm will receive regular well-child care. All providers in the control arm will have access to ETHR after the pilot trial is over |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Sees patient at an eligible primary care clinic
- Speaks and understands English
- Age 18 or older
- Identifies as a pediatrician, nurse practitioner, physician assistant (pediatric primary care healthcare provider)
- Adolescents
Key exclusion criteria (2 listed)
- Providers
- 1) Does not need inclusion criteria
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 |
|---|---|---|
| Engaging Together for Healthy RelationshipsA comprehensive parent-adolescent dating violence prevention intervention designed to be provider delivered within the context of a pediatric well-child visit | Behavioural | Intervention (Engaging Together for Healthy Relationships) |
| Regular well child careParticipants will receive their regularly scheduled well-child care | Behavioural | Control (Receipt of regular well-child care) |
Primary outcome
Percentage of participants who are eligible out of the total who are approached
Time frame: Through completion of study recruitment, an average of 6 months
Will assess through tracking data
Percentage of participants who are consented out of the total who are eligible
Time frame: Through completion of study recruitment, an average of 6 months
Will assess through tracking data
Percentage of participants who complete the baseline survey out of the total who consented
Time frame: Through completion of completing baseline surveys, an average of 6 months
Will assess through tracking data
Percentage of participants who complete the well-visit out of the total who consented
Time frame: Through completion of completing well-visits, an average of 6 months
Will assess through tracking data
Percentage of participants who complete the immediate post-intervention survey out of the total who consented
Time frame: Through completion of completing post-intervention survey, an average of 7 months
Will assess through tracking data
Percentage of participants who complete the 1-month post-intervention survey out of the total who consented
Time frame: 4 months
Through completion of completing 1- month post-intervention survey, an average of 8 months
Percentage of participants who complete the 3-month post-intervention survey out of the total who consented
Time frame: Through completion of completing 3 month post-intervention survey, an average of 12 months
Will assess through tracking data
Percentage of participants who strongly agree or agree that the intervention is acceptable using a 4-item validated measure (Acceptability of Intervention Measure)
Time frame: Through completion of completing immediate post-visit surveys, an average of 6 months
Validated measure (Acceptability of Intervention Measure)
6 secondary outcomes
Self-efficacy in preventing adolescent relationship abuse (ARA), change in outcome between baseline and 3 months
Time frame: Baseline, 3-month post intervention
Percentage of participants who utilize ARA resources at each measurement point, change in outcome over time
Time frame: Baseline, 1 month post intervention, 3 month post-intervention
Attitudes about ARA, change in outcome between baseline and 3 months
Time frame: Baseline, 3-month post intervention
Parent-adolescent communication around dating and ARA, change in outcome over time
Time frame: Baseline, 3-month post intervention
Parental monitoring around dating and ARA, change in outcome over time
Time frame: Baseline, 3-month post intervention
Percentage of adolescents reporting ARA victimization and perpetration
Time frame: Baseline, 3-month post intervention
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 3 Mar 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engaging Together for Healthy Relationships and Regular well child care in people with Violence in Adolescence and Domestic Violence, run by University of Pittsburgh 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 16 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: finished, as of the sponsor's last update on 3 Mar 2025. 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?
Percentage of participants who are eligible out of the total who are approached (time frame: Through completion of study recruitment, an average of 6 months). The study lists 8 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 3 Mar 2025; AzTrials last refreshed its copy on 28 Oct 2026.