Distress; MaternalNCT03487575
Integrated Intervention for Caregivers--Open Trial
A study testing Open trial in people with Distress; Maternal and Self-Efficacy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Adolescents who have been hospitalized for suicidal behavior are at risk for engaging in additional suicidal behavior. After hospitalization, parents or guardians are typically asked to be responsible for helping to prevent further suicidal behavior. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Distress; Maternal, Self-Efficacy, Parenting
- What is being tested?
- Open trial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to 19 Aug 2021
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biological, adoptive, or step-parent (step-parent defined as by marriage or live-in partner of at least 5 years) of an adolescent. If an adolescent has more than one parent, parents will be asked to designate the primary contact or participant for this study (only one parent for an adolescent may participate).
- The adolescent is 13-19 years of age
- The adolescent was psychiatrically hospitalized due to any range of suicidal behaviors (i.e., suicide attempt, interrupted suicide attempt, aborted suicide attempt) in the last two weeks
- The parent lives with the adolescent
- The parent has a cell phone and is capable of texting (i.e., has knowledge of how to text and has a data plan that allows for texting)
Who cannot join
- Parents whose primary language is not English and are unable to read or speak English, as all materials will be initially developed in English only
- Parents who have a reported intellectual disability (per inpatient staff)
- Parents whose adolescent is not discharged directly home (e.g., adolescent is sent to a group home, residential treatment facility, or home of a relative following hospitalization)
- Adolescents who have an intellectual disability (per inpatient staff or as reflected by current school placement) or have active psychosis, as the needs of both parent and youth may be different than those without an intellectual disability or active psychosis and are not specifically addressed in the proposed developing intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Integrated Electronic and Care Manager Support Intervention For Caregivers of Adolescents With Suicidal Behavior--Open Trial
Adolescents who have been hospitalized for suicidal behavior are at risk for engaging in additional suicidal behavior. After hospitalization, parents or guardians are typically asked to be responsible for helping to prevent further suicidal behavior. This can include monitoring the youth, making sure the home is safe, getting the youth any needed treatment, and balancing the parents' expectations of the youth with the understanding that the youth is in a vulnerable state. Even with these efforts by parents, adolescents often have additional crisis situations. The goal of this study is to develop and test an integrated electronic and care support service intervention for parents of suicidal youth. It is expected that this intervention will help parents/guardians in the roles of caring for suicidal youth after discharge from the hospital. This open trial will assess the feasibility of this intervention for a separate pilot randomized controlled trial to compare the intervention to enhanced treatment as usual.
Read the detailed description
Adolescents who have been hospitalized for suicidal behavior are at high risk for engaging in additional suicidal behavior. Following hospitalization, parents or guardians are typically tasked with helping to prevent further suicidal episodes by monitoring youth, ensuring safety in the home, helping youth receive needed care, and parenting in a way that balances expectations for appropriate behavior with recognition of the vulnerable status of the adolescents. Despite parental efforts, adolescents often have additional crises, which sometimes culminate in emergency department visits and repeat hospitalizations. Findings from the principal investigators' recent longitudinal study of mothers after adolescent hospitalization for suicide attempts (Impact of Adolescent Hospitalization on Parents) suggested that the period of time following discharge from the hospital can be a very important time for providing services and supports to youth and families. Parents in that study described emotional distress (e.g., depression, anxiety) and reduced parenting self-efficacy, and indicated a need for more information about suicidal youth and the treatment needs of these youth, parenting and monitoring of suicidal youth, and support in navigating the treatment system.
Given these needs, the purpose of this study is to develop, refine, and preliminarily test an integrated electronic and care support service intervention for caregivers of adolescents who have recently engaged in suicidal behavior. It is expected that such an intervention will provide needed information and supports to parents, increase parenting self-efficacy, increase parents' ability to follow safety plans in the home, reduce parents' emotional distress, and help parents access needed services in the community. As a consequence of these proximal outcomes, it is expected that the intervention will help facilitate treatment engagement and follow through for youth and caregiver, and reduce use of emergency mental health services and hospitalizations.
In the context of an open trial, the primary aim is to assess the feasibility of this intervention, and to use experiences from implementing the intervention and feedback from caregivers and care support managers to refine the intervention.
- Conditions
- Distress; Maternal, Self-Efficacy, Parenting, Suicide
- Being tested
- Open trial
- Keywords
- Adolescent, Parental Support, Parental Coping
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open trialBehavioural
Integrated electronic support and care support manager contact
| Study group | Role | What they receive |
|---|---|---|
| Open trial | Experimental | Not described Receives: Behavioral: Open trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parental distress as assessed with SCL-90-R
To assess severity of depression, anxiety, and hostility, parents will be administered the Symptom Checklist - 90 (SCL-90-R). The SCL-90-R yields scores along several dimensions: Somatization, Obsessive-Compulsive, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. The scale range for each dimension is a T-score of 0-100, with higher scores representing greater problem severity.
Measured: Baseline (hospitalization), and at 3- and 6- months following discharge
Change in parental self-efficacy as assessed with PSOC
Facets of parental self-efficacy will be assessed with the Parenting Sense of Competence Scale (PSOC), which measures sense of self-efficacy and satisfaction with parenting. It has a scale range of 17-102, with higher scores indicating a greater parenting sense of competency. It has been used with parents of children and adolescents.
Measured: Baseline (hospitalization), and at 3- and 6- months following discharge
Change in parental self-efficacy as assessed with "Me as a Parent" Parent Self-Regulation scale
Facets of parental self-efficacy will be assessed with the "Me as a Parent" Parenting Self-Regulation scale, which assesses constructs such as sense of effectiveness, sense of control as a parent, ability to manage situations with children (a central concept for the current study), and parental self-management (planful parenting activities). The scale range is 16 - 80, with higher scores representing a greater parental sense of self-regulation. It has been used with parents of children and adolescents.
Measured: Baseline (hospitalization), and at 3- and 6- months following discharge
Change in parenting practices as assessed with Alabama Parenting Practices Questionnaire
The Alabama Parenting Practices Questionnaire will be used to assess parenting behaviors. For purposes of our study, investigators will focus on the parental involvement subscale (10 items), the positive parenting subscale (6 items), the monitoring and supervision subscale (10 items), and the inconsistent discipline scale (6 items). The scale ranges are 10-50 for the 10-item subscales, and 6-30 for the 6-item subscales. Higher scores denote better outcomes for the parental involvement and positive parenting subscales, whereas higher scores denote worse outcomes for the monitoring/supervision and inconsistent discipline subscales.
Measured: Baseline (hospitalization), and at 3- and 6- months following discharge
Change in parent reports of adolescent suicidal behavior as assessed with C-SSRS
Parental reports of adolescent suicidal ideation and behaviors following hospitalization will be assessed with selected queries from the Columbia - Suicide Severity Rating Scale (C-SSRS). This measure does not have an overall scoring range, but it does include a suicidal ideation intensity rating with a range 0-25. In general, a greater number of endorsed items and/or a higher suicidal ideation intensity rating denote greater suicidal risk.
Measured: Baseline (hospitalization), and at 3- and 6- months following discharge
Change in child emotional and behavioral problems as assessed with CBCL
To provide some contextual information at each assessment, parents at baseline hospitalization only will complete the Achenbach Child Behavior Checklist (CBCL). The CBCL is a widely used parent-report scale. The measure includes 20 subscales, each having a T-score range of 50-100, with higher scores denoting greater psychological and behavioral problems.
Measured: Baseline (hospitalization), and at 3- and 6- months following discharge
Secondary outcomes (4)
Change in parent perceptions of support and safety monitoring as assessed with a series of likert rating questions
Using a series of likert rating questions, investigators also will assess the degree to which parents feel provided with information regarding their child's condition and the management of their child in the home, and the degree to which parents feel supported by the intervention and by mental health professionals. Investigators will use likert scales at formal assessment points to assess perceived success and confidence in monitoring youth and following safety plans in the first month after hospitalization, and during any other times of high risk. In addition to formal assessments, the care support manager will use ratings during regular check-ins to gauge the degree to which parents' needs are being met.
Measured: Through study completion, up to 6 months following discharge
Adolescent service use assessed with CASA and treatment records
The semi-structured interview-based Child and Adolescent Services Assessment-Parent Interview-Version 5.0 (CASA) will be used to assess emergency department visits and repeat hospitalizations; duration and frequency of adolescent involvement with specialty mental health services (therapists, psychiatrists, etc.) following hospitalization; and attitudes about service use for adolescents. In addition, with consent/assent of parents and adolescents, investigators will obtain adolescents' treatment records to verify contacts with mental health providers. This measure does not have an overall scale range.
Measured: Baseline (hospitalization), and at 3- and 6- months following discharge
Cost information assessed with measure of time spent
Time spent by the care support manager in patient contacts, preparation, and documentation will be tracked to estimate potential costs. These data will be preliminary due to the early phase of intervention development, but will set the stage for scalability efforts and later well-powered cost-effectiveness studies.
Measured: Up to 6 months following discharge
Assessment of the patient satisfaction and acceptability of the intervention assessed with Client Satisfaction Questionnaire
To assess patient satisfaction and acceptability of the intervention, investigators will administer the Client Satisfaction Questionnaire. This measure has a range of 8-32, with higher scores indicating greater satisfaction. Following Mohr et al. (2011), additional indices of the acceptability and usability of the intervention will include the degree to which parents use the mHealth application over time.
Measured: Through study completion, up to 6 months following discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start12 Aug 2020
- Primary completion19 Aug 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress; MaternalStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, University of Rochester
- Responsible party
- Sponsor
- Investigators
- Stephanie S Daniel, Ph.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487575
- Sponsor's protocol ID
- IRB00055566-OT
- Status last verified
- Oct 2021
- First submitted
- 16 Mar 2018
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In order to adhere to the goal of data sharing among researchers, investigators will share data from this study via the National Database for Clinical Trials related to Mental Illness (NDCT). Based on the procedures outlined on the NDCT web site, investigators will collect information necessary to generate a Global Unique Identifier (GUID), a universal subject identifier, for each participant. No personal identifying information, nor data that could be used deductively to identify participants, however, will be shared with other researchers, particularly given the relatively small size of the data set. The GUID will allow sharing of information across research studies. Research participants will be informed of the Resource Sharing Plan in the consent forms for participation in the studies, using text similar to the example plain language text for informed consent forms provided by the NDCT.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Electronic and Care Manager Support Intervention For Caregivers of Adolescents With Suicidal Behavior--Open Trial
- ClinicalTrials.gov ID
- NCT03487575
- Acronym / sponsor ID
- IRB00055566-OT
- Conditions
- Distress; Maternal, Self-Efficacy, Parenting, Suicide
- Keywords
- Adolescent, Parental Support, Parental Coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Duke University, University of Rochester
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 4 Apr 2018 (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.
Adolescents who have been hospitalized for suicidal behavior are at risk for engaging in additional suicidal behavior. After hospitalization, parents or guardians are typically asked to be responsible for helping to prevent further suicidal behavior. This can include monitoring the youth, making sure the home is safe, getting the youth any needed treatment, and balancing the parents' expectations of the youth with the understanding that the youth is in a vulnerable state. Even with these efforts by parents, adolescents often have additional crisis situations. The goal of this study is to develop and test an integrated electronic and care support service intervention for parents of suicidal youth. It is expected that this intervention will help parents/guardians in the roles of caring for suicidal youth after discharge from the hospital. This open trial will assess the feasibility of this intervention for a separate pilot randomized controlled trial to compare the intervention to enhanced treatment as usual.
Detailed description
Adolescents who have been hospitalized for suicidal behavior are at high risk for engaging in additional suicidal behavior. Following hospitalization, parents or guardians are typically tasked with helping to prevent further suicidal episodes by monitoring youth, ensuring safety in the home, helping youth receive needed care, and parenting in a way that balances expectations for appropriate behavior with recognition of the vulnerable status of the adolescents. Despite parental efforts, adolescents often have additional crises, which sometimes culminate in emergency department visits and repeat hospitalizations. Findings from the principal investigators' recent longitudinal study of mothers after adolescent hospitalization for suicide attempts (Impact of Adolescent Hospitalization on Parents) suggested that the period of time following discharge from the hospital can be a very important time for providing services and supports to youth and families. Parents in that study described emotional distress (e.g., depression, anxiety) and reduced parenting self-efficacy, and indicated a need for more information about suicidal youth and the treatment needs of these youth, parenting and monitoring of suicidal youth, and support in navigating the treatment system.
Given these needs, the purpose of this study is to develop, refine, and preliminarily test an integrated electronic and care support service intervention for caregivers of adolescents who have recently engaged in suicidal behavior. It is expected that such an intervention will provide needed information and supports to parents, increase parenting self-efficacy, increase parents' ability to follow safety plans in the home, reduce parents' emotional distress, and help parents access needed services in the community. As a consequence of these proximal outcomes, it is expected that the intervention will help facilitate treatment engagement and follow through for youth and caregiver, and reduce use of emergency mental health services and hospitalizations.
In the context of an open trial, the primary aim is to assess the feasibility of this intervention, and to use experiences from implementing the intervention and feedback from caregivers and care support managers to refine the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open trial | Experimental | Behavioral: Open trial |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Biological, adoptive, or step-parent (step-parent defined as by marriage or live-in partner of at least 5 years) of an adolescent. If an adolescent has more than one parent, parents will be asked to designate the primary contact or participant for this study (only one parent for an adolescent may participate).
- The adolescent is 13-19 years of age
- The adolescent was psychiatrically hospitalized due to any range of suicidal behaviors (i.e., suicide attempt, interrupted suicide attempt, aborted suicide attempt) in the last two weeks
- The parent lives with the adolescent
- The parent has a cell phone and is capable of texting (i.e., has knowledge of how to text and has a data plan that allows for texting)
Key exclusion criteria (4 listed)
- Parents whose primary language is not English and are unable to read or speak English, as all materials will be initially developed in English only
- Parents who have a reported intellectual disability (per inpatient staff)
- Parents whose adolescent is not discharged directly home (e.g., adolescent is sent to a group home, residential treatment facility, or home of a relative following hospitalization)
- Adolescents who have an intellectual disability (per inpatient staff or as reflected by current school placement) or have active psychosis, as the needs of both parent and youth may be different than those without an intellectual disability or active psychosis and are not specifically addressed in the proposed developing intervention
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 |
|---|---|---|
| Open trialIntegrated electronic support and care support manager contact | Behavioural | Open trial |
Primary outcome
Change in parental distress as assessed with SCL-90-R
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
To assess severity of depression, anxiety, and hostility, parents will be administered the Symptom Checklist - 90 (SCL-90-R). The SCL-90-R yields scores along several dimensions: Somatization, Obsessive-Compulsive, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. The scale range for each dimension is a T-score of 0-100, with higher scores representing greater problem severity.
Change in parental self-efficacy as assessed with PSOC
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
Facets of parental self-efficacy will be assessed with the Parenting Sense of Competence Scale (PSOC), which measures sense of self-efficacy and satisfaction with parenting. It has a scale range of 17-102, with higher scores indicating a greater parenting sense of competency. It has been used with parents of children and adolescents.
Change in parental self-efficacy as assessed with "Me as a Parent" Parent Self-Regulation scale
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
Facets of parental self-efficacy will be assessed with the "Me as a Parent" Parenting Self-Regulation scale, which assesses constructs such as sense of effectiveness, sense of control as a parent, ability to manage situations with children (a central concept for the current study), and parental self-management (planful parenting activities). The scale range is 16 - 80, with higher scores representing a greater parental sense of self-regulation. It has been used with parents of children and adolescents.
Change in parenting practices as assessed with Alabama Parenting Practices Questionnaire
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
The Alabama Parenting Practices Questionnaire will be used to assess parenting behaviors. For purposes of our study, investigators will focus on the parental involvement subscale (10 items), the positive parenting subscale (6 items), the monitoring and supervision subscale (10 items), and the inconsistent discipline scale (6 items). The scale ranges are 10-50 for the 10-item subscales, and 6-30 for the 6-item subscales. Higher scores denote better outcomes for the parental involvement and positive parenting subscales, whereas higher scores denote worse outcomes for the monitoring/supervision and inconsistent discipline subscales.
Change in parent reports of adolescent suicidal behavior as assessed with C-SSRS
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
Parental reports of adolescent suicidal ideation and behaviors following hospitalization will be assessed with selected queries from the Columbia - Suicide Severity Rating Scale (C-SSRS). This measure does not have an overall scoring range, but it does include a suicidal ideation intensity rating with a range 0-25. In general, a greater number of endorsed items and/or a higher suicidal ideation intensity rating denote greater suicidal risk.
Change in child emotional and behavioral problems as assessed with CBCL
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
To provide some contextual information at each assessment, parents at baseline hospitalization only will complete the Achenbach Child Behavior Checklist (CBCL). The CBCL is a widely used parent-report scale. The measure includes 20 subscales, each having a T-score range of 50-100, with higher scores denoting greater psychological and behavioral problems.
4 secondary outcomes
Change in parent perceptions of support and safety monitoring as assessed with a series of likert rating questions
Time frame: Through study completion, up to 6 months following discharge
Adolescent service use assessed with CASA and treatment records
Time frame: Baseline (hospitalization), and at 3- and 6- months following discharge
Cost information assessed with measure of time spent
Time frame: Up to 6 months following discharge
Assessment of the patient satisfaction and acceptability of the intervention assessed with Client Satisfaction Questionnaire
Time frame: Through study completion, up to 6 months following discharge
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 Nov 2021.
- Individual participant dataSharing planned: Yes. In order to adhere to the goal of data sharing among researchers, investigators will share data from this study via the National Database for Clinical Trials related to Mental Illness (NDCT). Based on the procedures outlined on the NDCT web site, investigators will collect information necessary to generate a Global Unique Identifier (GUID), a universal subject identifier, for each participant. No personal identifying information, nor data that could be used deductively to identify participants, however, will be shared with other researchers, particularly given the relatively small size of the data set. The GUID will allow sharing of information across research studies. Research participants will be informed of the Resource Sharing Plan in the consent forms for participation in the studies, using text similar to the example plain language text for informed consent forms provided by the NDCT.
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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.
Stephanie S Daniel, Ph.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open trial in people with Distress; Maternal and Self-Efficacy, run by Wake Forest University Health Sciences 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 5 inclusion and 4 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 Nov 2021. 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?
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?
Change in parental distress as assessed with SCL-90-R (time frame: Baseline (hospitalization), and at 3- and 6- months following discharge). The study lists 6 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 Nov 2021; AzTrials last refreshed its copy on 27 Oct 2026.