ParentsiPEACENCT06456762
Text-messaging Intervention to Support Parents After Their Child's Psychiatric Emergency
A study testing iPEACE: Intervention for Parent Education about Care after the ED and Text Messaging Reminders Only in people with Parents and Self Efficacy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This grant aims to develop and test a text-messaging intervention for parents of children and teens evaluated in the emergency department for a psychiatric emergency and discharged home with outpatient referrals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parents, Self Efficacy, Mental Health Literacy
- What is being tested?
- iPEACE: Intervention for Parent Education about Care after the ED and Text Messaging Reminders Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parents or legal guardians of a child ages 11-17;
- Parents or legal guardians must live with their child ≥50% of the time;
- Child must be admitted to the pediatric emergency department for a mental health crisis;
- Child must be discharged home from the emergency department with referrals to outpatient care.
Who cannot join
- Do not have daily access to a mobile phone that can receive SMS text messages;
- Do not speak and read fluently in English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Margaret Benningfield, MD, 615-612-8324, margaret.m.benningfield@vumc.org
Neil Charturvedi, 6159339731, neil.chaturvedi@vumc.org
About this study
Official title: Developing and Testing a Text-messaging Intervention to Support Parents After Their Child's Psychiatric Emergency
This grant aims to develop and test a text-messaging intervention for parents of children and teens evaluated in the emergency department for a psychiatric emergency and discharged home with outpatient referrals. The intervention for parents will teach parents skills to navigate the mental health services system and build their self-efficacy in managing their child's mental health. This research has the potential to improve services for families seeking emergency psychiatric support, with the goal of facilitating treatment engagement and reducing emergency services utilization using scalable, cost-effective, accessible tools.
Read the detailed description
Rates of emergency department (ED) visits for psychiatric emergencies in adolescents have increased substantially in the past decade, including for suicidality, self-harm, and aggression. A substantial number of these adolescents will be discharged home from the ED with referrals to outpatient mental health treatment. Yet, engagement in outpatient mental health treatment among adolescents is low, and rates of repeated emergency services utilization are high, highlighting the need for better supports for these youth and families. While effective, brief interventions have been developed to directly support adolescents at the time of their ED visit, no evidence-based interventions have been developed to support parents of these youth. Further, the period following an emergency visit is known to be high risk, yet no existing services support parents during the transition home, while waiting for connection to outpatient services. In this intervention development study, the investigators seek to iteratively develop, refine, and test an automated, text-messaging intervention for parents of youth discharged from the ED after a psychiatric emergency. The 8-week intervention (iPEACE; intervention for parent education after care in the ED) will directly target (1) parent mental health literacy and (2) parent self-efficacy, with the goal of reducing ED utilization and enhancing outpatient mental health service use and engagement. In the first phase of the study, the investigators aim to develop and refine the intervention with stakeholder feedback. Parents (N=15) will receive the 8-week iPEACE starting immediately following ED discharge. Parents will provide both in-the-moment feedback via text-message surveys and in-depth feedback at the end of the 8-week period via semi-structured qualitative interviews and self-report measures. The investigators will also conduct qualitative interviews with enrolled parents' children and key ED stakeholders. The investigators will use this feedback to refine the intervention materials. In the second phase of the study, the investigators will conduct a pilot randomized controlled trial (N=90), with n=30 parents randomized to enhanced usual care, n=30 randomized to enhanced usual care with text-message reminders, and n=30 randomized to receive iPEACE. Parents and their child evaluated in the ED will complete follow-up assessments at 4-, 8- and 24-weeks to assess key intervention targets (self-efficacy and mental health literacy) and youth outcomes (outpatient mental health service utilization, ED utilization, clinical symptom severity). The goals for the proposed project include: (1) developing and refining the iPEACE text-messaging intervention; and (2) piloting the iPEACE intervention compared to enhanced usual care only and enhanced usual care with text-message reminders to assess key study outcomes and mechanisms to inform a fully-power randomized trial. This R34 has important clinical implications, as findings from this study may support the testing and implementation of a digital health intervention to improve outcomes for high-risk youth and families. The proposed study has the potential to inform the provision of clinical services to support families during high-risk clinical transitions.
- Conditions
- Parents, Self Efficacy, Mental Health Literacy, Psychiatric Emergency
- Being tested
- iPEACE: Intervention for Parent Education about Care after the ED, Text Messaging Reminders Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPEACE: Intervention for Parent Education about Care after the EDBehavioural
Automated texting intervention for parents to increase engagement in their child's outpatient mental health treatment over an 8-week period.
Text Messaging Reminders OnlyBehavioural
Weekly automated text reminders to instruct parents to make an appointment with their child's outpatient mental health provider over an 8-week period.
| Study group | Role | What they receive |
|---|---|---|
| iPEACE: Intervention for Parent Education About Care after the ED | Active comparator | Parents in the iPEACE condition will receive an 8-week text-messaging intervention to build skills in mental health literacy and self-efficacy. Texts will be delivered several days per week over an 8-week period. The intervention is fully automated. Receives: Behavioral: iPEACE: Intervention for Parent Education about Care after the ED |
| Text Reminders Only | Active comparator | Parents in the text-reminders only condition will receive weekly reminders to make an outpatient therapy appointment for their child. Texts will be fully automated, and will be delivered once a week for 8-weeks. Receives: Behavioral: Text Messaging Reminders Only |
| Treatment as Usual | No intervention | Parents in the TAU condition will receive typical treatment in the emergency department, including outpatient referrals and safety planning if needed prior to discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child and Adolescent Services Assessment: Outpatient Mental Health Service Utilization
The Child and Adolescent Services Assessment will be used as a parent self-report measure that evaluates the total number of outpatient mental health appointments the participant's child attends during the follow-up period. The outcome will be a total count of the number of outpatient mental health appointments attended.
Measured: 24 weeks
Child and Adolescent Services Assessment: Emergency Department Services Use
The Child and Adolescent Services Assessment will be used as a parent self-report measure to evaluate the number of psychiatric emergency department visits the participant's child has during the follow-up period. The outcome variable will be a dichotomous variable based on whether the child was readmitted to the emergency department during the follow-up period (yes/no).
Measured: 24 weeks
Secondary outcomes (2)
Suicidal Ideation Questionnaire - Jr.
Child suicidal thoughts will be assessed using the Suicidal Ideation Questionnaire-Jr. child self-report measure over follow up period. Scores range from 0-90, with higher scores reflecting higher suicidal ideation severity. The clinical cutoff score is 31.
Measured: 24 weeks
Self-Injurious Thoughts and Behaviors Interview - Revised
Child suicidal thoughts and behaviors will be assessed using an adapted version of the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R); the study will use a child self-report version of the SITBI-R. The SITBI-R will provide outcome scores on the presence or absence of a suicide attempt during the follow up period and the presence or absence of passive and active suicidal ideation during the follow up period.
Measured: 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Margaret M. Benningfield, Vanderbilt University Medical Center
- Investigators
- Margaret Benningfield, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456762
- Sponsor's protocol ID
- 231812
- Other IDs
- R34MH132711-01A1
- Acronym
- iPEACE
- Status last verified
- Nov 2025
- First submitted
- 7 Jun 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share data in accordance with the National Institutes of Health data sharing policy. Researchers can use the standard request process through the NIMH Data Archive to request access to the research data. The NIMH Data Archive Data Access Committee makes decisions about granting research access, which is allowable for one year with an option to renew.Data provided to the NDA will be de-identified and all participants will consent to data sharing at the time of study enrollment. The NIMH Data Archive GUID allows researchers to aggregate data from a single research participant such that they remain deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Text-messaging Intervention to Support Parents After Their Child's Psychiatric Emergency
- ClinicalTrials.gov ID
- NCT06456762
- Acronym / sponsor ID
- iPEACE / 231812
- Conditions
- Parents, Self Efficacy, Mental Health Literacy, Psychiatric Emergency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jun 2024 (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 grant aims to develop and test a text-messaging intervention for parents of children and teens evaluated in the emergency department for a psychiatric emergency and discharged home with outpatient referrals. The intervention for parents will teach parents skills to navigate the mental health services system and build their self-efficacy in managing their child's mental health. This research has the potential to improve services for families seeking emergency psychiatric support, with the goal of facilitating treatment engagement and reducing emergency services utilization using scalable, cost-effective, accessible tools.
Detailed description
Rates of emergency department (ED) visits for psychiatric emergencies in adolescents have increased substantially in the past decade, including for suicidality, self-harm, and aggression. A substantial number of these adolescents will be discharged home from the ED with referrals to outpatient mental health treatment. Yet, engagement in outpatient mental health treatment among adolescents is low, and rates of repeated emergency services utilization are high, highlighting the need for better supports for these youth and families. While effective, brief interventions have been developed to directly support adolescents at the time of their ED visit, no evidence-based interventions have been developed to support parents of these youth. Further, the period following an emergency visit is known to be high risk, yet no existing services support parents during the transition home, while waiting for connection to outpatient services. In this intervention development study, the investigators seek to iteratively develop, refine, and test an automated, text-messaging intervention for parents of youth discharged from the ED after a psychiatric emergency. The 8-week intervention (iPEACE; intervention for parent education after care in the ED) will directly target (1) parent mental health literacy and (2) parent self-efficacy, with the goal of reducing ED utilization and enhancing outpatient mental health service use and engagement. In the first phase of the study, the investigators aim to develop and refine the intervention with stakeholder feedback. Parents (N=15) will receive the 8-week iPEACE starting immediately following ED discharge. Parents will provide both in-the-moment feedback via text-message surveys and in-depth feedback at the end of the 8-week period via semi-structured qualitative interviews and self-report measures. The investigators will also conduct qualitative interviews with enrolled parents' children and key ED stakeholders. The investigators will use this feedback to refine the intervention materials. In the second phase of the study, the investigators will conduct a pilot randomized controlled trial (N=90), with n=30 parents randomized to enhanced usual care, n=30 randomized to enhanced usual care with text-message reminders, and n=30 randomized to receive iPEACE. Parents and their child evaluated in the ED will complete follow-up assessments at 4-, 8- and 24-weeks to assess key intervention targets (self-efficacy and mental health literacy) and youth outcomes (outpatient mental health service utilization, ED utilization, clinical symptom severity). The goals for the proposed project include: (1) developing and refining the iPEACE text-messaging intervention; and (2) piloting the iPEACE intervention compared to enhanced usual care only and enhanced usual care with text-message reminders to assess key study outcomes and mechanisms to inform a fully-power randomized trial. This R34 has important clinical implications, as findings from this study may support the testing and implementation of a digital health intervention to improve outcomes for high-risk youth and families. The proposed study has the potential to inform the provision of clinical services to support families during high-risk clinical transitions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iPEACE: Intervention for Parent Education About Care after the ED | Active comparator | Behavioral: iPEACE: Intervention for Parent Education about Care after the EDParents in the iPEACE condition will receive an 8-week text-messaging intervention to build skills in mental health literacy and self-efficacy. Texts will be delivered several days per week over an 8-week period. The intervention is fully automated. |
| Text Reminders Only | Active comparator | Behavioral: Text Messaging Reminders OnlyParents in the text-reminders only condition will receive weekly reminders to make an outpatient therapy appointment for their child. Texts will be fully automated, and will be delivered once a week for 8-weeks. |
| Treatment as Usual | No intervention | –Parents in the TAU condition will receive typical treatment in the emergency department, including outpatient referrals and safety planning if needed prior to discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parents or legal guardians of a child ages 11-17;
- Parents or legal guardians must live with their child ≥50% of the time;
- Child must be admitted to the pediatric emergency department for a mental health crisis;
- Child must be discharged home from the emergency department with referrals to outpatient care.
Key exclusion criteria (2 listed)
- Do not have daily access to a mobile phone that can receive SMS text messages;
- Do not speak and read fluently in English.
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 |
|---|---|---|
| iPEACE: Intervention for Parent Education about Care after the EDAutomated texting intervention for parents to increase engagement in their child's outpatient mental health treatment over an 8-week period. | Behavioural | iPEACE: Intervention for Parent Education About Care after the ED |
| Text Messaging Reminders OnlyWeekly automated text reminders to instruct parents to make an appointment with their child's outpatient mental health provider over an 8-week period. | Behavioural | Text Reminders Only |
Primary outcome
Child and Adolescent Services Assessment: Outpatient Mental Health Service Utilization
Time frame: 24 weeks
The Child and Adolescent Services Assessment will be used as a parent self-report measure that evaluates the total number of outpatient mental health appointments the participant's child attends during the follow-up period. The outcome will be a total count of the number of outpatient mental health appointments attended.
Child and Adolescent Services Assessment: Emergency Department Services Use
Time frame: 24 weeks
The Child and Adolescent Services Assessment will be used as a parent self-report measure to evaluate the number of psychiatric emergency department visits the participant's child has during the follow-up period. The outcome variable will be a dichotomous variable based on whether the child was readmitted to the emergency department during the follow-up period (yes/no).
2 secondary outcomes
Suicidal Ideation Questionnaire - Jr.
Time frame: 24 weeks
Self-Injurious Thoughts and Behaviors Interview - Revised
Time frame: 24 weeks.
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 10 Nov 2025.
- Individual participant dataSharing planned: Yes. We will share data in accordance with the National Institutes of Health data sharing policy. Researchers can use the standard request process through the NIMH Data Archive to request access to the research data. The NIMH Data Archive Data Access Committee makes decisions about granting research access, which is allowable for one year with an option to renew.Data provided to the NDA will be de-identified and all participants will consent to data sharing at the time of study enrollment. The NIMH Data Archive GUID allows researchers to aggregate data from a single research participant such that they remain deidentified.
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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.
Margaret Benningfield, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPEACE: Intervention for Parent Education about Care after the ED and Text Messaging Reminders Only in people with Parents and Self Efficacy, run by Vanderbilt University Medical Center 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 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 10 Nov 2025. 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?
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 Margaret Benningfield, MD (6156128324, margaret.m.benningfield@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child and Adolescent Services Assessment: Outpatient Mental Health Service Utilization (time frame: 24 weeks). The study lists 2 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 10 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.