Mental Health IssuePROACTIVENCT04986800
Providing Access To Innovative & Evidence-Based Intervention
A study testing PROACTIVE Parent in people with Mental Health Issue, run by Northwestern University at 1 site in United States.
Trial summary
PROACTIVE Parent is an educational program designed to improve parenting skills to more effectively manage child behavior and social and emotional needs in children with depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- PROACTIVE Parent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 28 Dec 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Foster parent of child aged 8 - 13 years old with mental health symptoms
- Has access to a device and internet to allow videoconferencing or phone coaching
Who cannot join
- Not currently parenting a child with symptoms or history of depression
- Does not speak English
- Does not have access to a device and internet to allow videoconferencing or phone coaching
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROACTIVE Parent: Providing Access To Innovative & Evidence-Based Intervention
PROACTIVE Parent is an educational program designed to improve parenting skills to more effectively manage child behavior and social and emotional needs in children with depressive symptoms. PROACTIVE Parent (Providing Access To Innovative \& Evidence-Based Intervention) is a new service delivery model that uses telehealth methodology to engage parents in managing their child's mental health needs. PROACTIVE Parent aims to provide parents with information about their child's mental health symptoms and diagnosis, options for evidence-based treatment interventions, and a free, online application for identifying appropriate and accessible treatment options. PROACTIVE Parent is also designed to provide parents a deeper understanding of the function of child behavior, and strategies to promote effective behavior management and healthy coping. Parents will also learn skills to manage their own emotional dysregulation to promote calm parental responding and healthy parent-child interaction and communication. The investigators will assess the acceptability, feasibility, and preliminary effectiveness of a 10-week curriculum. Outcomes include parent reports of acceptability, utility, feasibility of program elements, and the preliminary effectiveness of the program in improving parent activation, parent empowerment, parent emotion dysregulation, and reducing child mental health and behavioral symptoms, and barriers to treatment participation.
Read the detailed description
PROACTIVE Parent is an educational program designed to improve parent knowledge, capacity and confidence to more effectively manage child behavior and social and emotional needs in children with depressive symptoms. PROACTIVE Parent (Providing Access To Innovative \& Evidence-Based Intervention) is a new service delivery model that uses telehealth methodology to educate parents about their child's mental health (MH) symptoms and treatment, teach parents skills to promote a safe, regulated environment for their youth, and teach parents how to work with their child's therapists to support treatment goals at home and in the community. PROACTIVE Parent will teach parents the function of child behavior, the role of symptomatology in child behaviors, and strategies to promote effective behavior management and healthy coping. Parents will also learn skills to manage their own emotional dysregulation to promote calm parental responding and promote healthy parent-child interaction and communication.
The PROACTIVE Parent model is ideally suited to promote parent's active management of child MH care. Children depend on parents to navigate a complex system of care and support children's coping in the home and community. However, parents may not know how to navigate appropriate treatments, how to communicate with their child's therapist to support treatment goals in the home, or how to interact with their child in a way that supports positive mental health outcomes. These parents require a service model that builds parent capacity to manage their child's MH care. The conceptual framework for the proposed work draws on the concept of parent activation and engagement in their child's MH care, and regulating affect. Activation refers to the parent's knowledge, capacity, and commitment to manage their child's MH care. Engagement refers to actions parents take to manage their child's care. Emotion regulation skills help parents to manage their affect, to engage in calm responding to children's needs and assist children in regulating affect.
PROACTIVE Parent is delivered in weekly 30-minute telehealth coaching sessions over the course of 10 weeks. Parent coaches use motivational interviewing and psychoeducation to improve parent activation and management of their child's MH care. Parent coaches provide parent-training and evidence-based skills training to promote effective parent behavior, healthy coping, and positive parent-child interaction. The parent coach will deliver the PROACTIVE Parent model via telehealth with supplemental online resources, using a publically available service referral system to connect parents to evidence-based treatments and MH providers if needed.
The investigators will recruit Foster Parents of youth in care aged 8 - 13 years, with symptoms or history of depression to examine acceptability, feasibility and preliminary effectiveness of the PROACTIVE Parent program.
The Aims of this project include an open trial, and exploration of the relationship between parent activation and youth MH outcomes.
Aim 1: Conduct a pilot study to test acceptability, utility, feasibility, and preliminary effectiveness. The primary outcomes include: 1) Acceptability, 2) Usefulness, and 3) Feasibility (all measured by post-session questions and post-intervention Customer Satisfaction Survey; Feasibility will also include number of people referred who meet eligibility, number of parents who enroll after referral, time to complete assessments). Aim 2: Assess the preliminary effectiveness of the model to improve parent activation, and empowerment. Aim 3: Assess the preliminary effectiveness to reduce the number, severity, and frequency of child MH symptoms and maladaptive behaviors. Aim 4: Assess preliminary effectiveness of improving parent scores on the DERS and barriers to treatment participation.
If the PROACTIVE Parent model demonstrates feasibility and effectiveness, it could serve as a model for scaling up to a population-based approach to MH treatment for all children.
- Conditions
- Mental Health Issue
- Being tested
- PROACTIVE Parent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROACTIVE ParentBehavioural
PROACTIVE Parent will educate parents about their child's mental health symptoms and treatment, how to talk to the child's therapist to support treatment goals at home and in the community. PROACTIVE Parent will teach parents the function of child behavior, the role of symptomatology in child behaviors, and strategies to promote effective behavior management and healthy coping. Parents will also learn skills to manage their own emotional dysregulation to promote calm parental responding and promote healthy parent-child interaction and communication.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the Intervention Group will receive up to 10 sessions of the PROACTIVE Parent intervention. Receives: Behavioral: PROACTIVE Parent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire (CSQ) is an 8-item scale with response options ranging from 1 - 4. Total scores range from 8 -32. Higher scores indicate higher satisfaction. Assesses the extent to which parents found the intervention helpful, relevant, feasible, and effective.
Measured: baseline
Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire (CSQ) is an 8-item scale with response options ranging from 1 - 4. Total scores range from 8 -32. Higher scores indicate higher satisfaction. Assesses the extent to which parents found the intervention helpful, relevant, feasible, and effective.
Measured: 11 weeks
Parent-Patient Activation Measure - Mental Health
The Parent-Patient Activation Measure - Mental Health measures parent activation, defined as the knowledge, ability, and confidence to manage their child's mental health care. It consists of 13 items on a 4-point Likert-type scale ranging from 1-4. Item scores are summed for a total composite score ranging from 13 -52. Composite scores are linearly transformed into scores ranging from 0 - 100. Higher scores indicate higher activation in managing their child's mental health care.
Measured: baseline
Parent-Patient Activation Measure - Mental Health
The Parent-Patient Activation Measure - Mental Health measures parent activation, defined as the knowledge, ability, and confidence to manage their child's mental health care. It consists of 13 items on a 4-point Likert-type scale ranging from 1-4. Item scores are summed for a total composite score ranging from 13 -52. Composite scores are linearly transformed into scores ranging from 0 - 100. Higher scores indicate higher activation in managing their child's mental health care.
Measured: 11 weeks
Family Empowerment Scale
The Family Empowerment Scale consists of 34-items and 3 subscales (1. Family, 2. Mental health services, 3. Community) designed to assess a parent's sense of empowerment in families of children with an emotional disorder. Response options range from 1 (not true at all) - 5 (very true). Total scores range from 34 - 170, with higher scores indicating higher levels of empowerment.
Measured: baseline
Family Empowerment Scale
The Family Empowerment Scale consists of 34-items and 3 subscales (1. Family, 2. Mental health services, 3. Community) designed to assess a parent's sense of empowerment in families of children with an emotional disorder. Response options range from 1 (not true at all) - 5 (very true). Total scores range from 34 - 170, with higher scores indicating higher levels of empowerment.
Measured: 11 weeks
Secondary outcomes (12)
PROMIS Parent-Proxy Pediatric Anxiety Short Form 8a (PROMIS Anxiety)
The PROMIS Parent-Proxy Pediatric Anxiety Short Form 8a is an 8-item measure that assesses symptoms of fear, anxious misery, hyperarousal, and somatic symptoms related to arousal among pediatric populations aged 5- to 17-years old. It is a parent report with response options that range from 1 (never) to 5 (almost always). Total scores range from 8 -40 with higher scores indicating higher levels of anxiety.
Measured: baseline
PROMIS Parent-Proxy Pediatric Anxiety Short Form 8a (PROMIS Anxiety)
The PROMIS Parent-Proxy Pediatric Anxiety Short Form 8a is an 8-item measure that assesses symptoms of fear, anxious misery, hyperarousal, and somatic symptoms related to arousal among pediatric populations aged 5- to 17-years old. It is a parent report with response options that range from 1 (never) to 5 (almost always). Total scores range from 8 -40 with higher scores indicating higher levels of anxiety.
Measured: 11 weeks
PROMIS Parent-Proxy Pediatric Depressive Symptoms Short Form 8a (PROMIS Depressive)
The PROMIS Parent-Proxy Pediatric Depressive Symptoms Short Form 8a is an 8-item measures that assesses negative mood and views of self, social cognition, and decreased positive affect and engagement among pediatric populations aged 5- to 17-years old. It is a parent-report and response options range from 1 (never) to 5 (almost always). Total scores range from 8 - 40 with higher scores indicating higher levels of depressive symptomatology.
Measured: baseline
PROMIS Parent-Proxy Pediatric Depressive Symptoms Short Form 8a (PROMIS Depressive)
The PROMIS Parent-Proxy Pediatric Depressive Symptoms Short Form 8a is an 8-item measures that assesses negative mood and views of self, social cognition, and decreased positive affect and engagement among pediatric populations aged 5- to 17-years old. It is a parent-report and response options range from 1 (never) to 5 (almost always). Total scores range from 8 - 40 with higher scores indicating higher levels of depressive symptomatology.
Measured: 11 weeks
Pediatric Symptom Checklist - 17 (PSC-17)
The Pediatric Symptom Checklist - 17 (PSC-17) is a 17-item measures that assesses child psychosocial function associated with internalizing, externalizing, and attention problems in children aged 5- to 17-years old. The parent report version will be used. Response options range from 0 (Never) - 2 (Often). Total scores range from 0 - 51; Scores on the Internalizing subscale range from 0 - 15, Scores on the Attention subscale range from 0 - 15, Scores on the Externalizing subscale range from 0 - 35. Higher scores indicate higher levels of symptomatology.
Measured: baseline
Pediatric Symptom Checklist - 17 (PSC-17)
The Pediatric Symptom Checklist - 17 (PSC-17) is a 17-item measures that assesses child psychosocial function associated with internalizing, externalizing, and attention problems in children aged 5- to 17-years old. The parent report version will be used. Response options range from 0 (Never) - 2 (Often). Total scores range from 0 - 51; Scores on the Internalizing subscale range from 0 - 15, Scores on the Attention subscale range from 0 - 15, Scores on the Externalizing subscale range from 0 - 35. Higher scores indicate higher levels of symptomatology.
Measured: 11 weeks
Barriers to Treatment Participation Scale; subscales I - IV
The Barriers to Treatment Participation Scale consists of 44 items and 4 subscales. The subscales include: I. Stressors (20 items; Response options 1 (never a problem) -5 (very often a problem)); II. Tx Demands (10 items; Response options 1-5); III Relevance (8 items; Response options: 1-5); IV Relationship (6 items; 1 -5); Total scores for the subscales with continuous response options range from 44- 220, With higher scores indicating higher barriers to treatment participation.
Measured: baseline
Barriers to Treatment Participation Scale; subscale V
The Barriers to Treatment Participation Scale consists of a fifth subscale, Critical Events (14 items; scored yes/no).
Measures the extent to which the parent experienced barriers to their child participating in treatment, and specific types of barriers to treatment.
Measured: baseline
Barriers to Treatment Participation Scale; subscales I - IV
The Barriers to Treatment Participation Scale consists of 44 items and 4 subscales. The subscales include: I. Stressors (20 items; Response options 1 (never a problem) -5 (very often a problem)); II. Tx Demands (10 items; Response options 1-5); III Relevance (8 items; Response Options: 1-5); IV Relationship (6 items; 1 -5); Total scores for the subscales with continuous response options range from 44- 220, With higher scores indicating higher barriers to treatment participation.
Measured: 11 weeks
Barriers to Treatment Participation Scale; subscale V
The Barriers to Treatment Participation Scale consists of a fifth subscale, Critical Events (14 items; scored yes/no).
Measures the extent to which the parent experienced barriers to their child participating in treatment, and specific types of barriers to treatment.
Measured: 11 weeks
Difficulties in Emotion Regulation Scale (DERS)
Measures four aspects of parental emotion regulation: (a) awareness and understanding of emotions; (b) acceptance of emotions; (c) the ability to control impulses and behave in accordance with goals in the presence of negative affect; and (d) access to emotion.
Measured: baseline
Difficulties in Emotion Regulation Scale (DERS)
Measures four aspects of parental emotion regulation: (a) awareness and understanding of emotions; (b) acceptance of emotions; (c) the ability to control impulses and behave in accordance with goals in the presence of negative affect; and (d) access to emotion.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Dec 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion28 Dec 2026 (estimated)
Why it stopped: Was never funded. Through rounds of grant applications, the intervention changed substantially based on reviewer feedback and feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A service delivery model and telehealth methodology to deliver a combination of mental health evaluation of the child, motivational interviewing, transdiagnostic and evidence-based skills training (ST), and parent training (PT) to parents.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Risser, Northwestern University
- Investigators
- Heather J Risser, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986800
- Sponsor's protocol ID
- STU00214486
- Acronym
- PROACTIVE
- Status last verified
- Mar 2024
- First submitted
- 24 May 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are concerned that parents will be less likely to participate if their individual participant data is to be shared. Particularly in communities of color, there is a history of exploitation in research.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROACTIVE Parent: Providing Access To Innovative & Evidence-Based Intervention
- ClinicalTrials.gov ID
- NCT04986800
- Acronym / sponsor ID
- PROACTIVE / STU00214486
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Was never funded. Through rounds of grant applications, the intervention changed substantially based on reviewer feedback and feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 3 Aug 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.
PROACTIVE Parent is an educational program designed to improve parenting skills to more effectively manage child behavior and social and emotional needs in children with depressive symptoms. PROACTIVE Parent (Providing Access To Innovative \& Evidence-Based Intervention) is a new service delivery model that uses telehealth methodology to engage parents in managing their child's mental health needs. PROACTIVE Parent aims to provide parents with information about their child's mental health symptoms and diagnosis, options for evidence-based treatment interventions, and a free, online application for identifying appropriate and accessible treatment options. PROACTIVE Parent is also designed to provide parents a deeper understanding of the function of child behavior, and strategies to promote effective behavior management and healthy coping. Parents will also learn skills to manage their own emotional dysregulation to promote calm parental responding and healthy parent-child interaction and communication. The investigators will assess the acceptability, feasibility, and preliminary effectiveness of a 10-week curriculum. Outcomes include parent reports of acceptability, utility, feasibility of program elements, and the preliminary effectiveness of the program in improving parent activation, parent empowerment, parent emotion dysregulation, and reducing child mental health and behavioral symptoms, and barriers to treatment participation.
Detailed description
PROACTIVE Parent is an educational program designed to improve parent knowledge, capacity and confidence to more effectively manage child behavior and social and emotional needs in children with depressive symptoms. PROACTIVE Parent (Providing Access To Innovative \& Evidence-Based Intervention) is a new service delivery model that uses telehealth methodology to educate parents about their child's mental health (MH) symptoms and treatment, teach parents skills to promote a safe, regulated environment for their youth, and teach parents how to work with their child's therapists to support treatment goals at home and in the community. PROACTIVE Parent will teach parents the function of child behavior, the role of symptomatology in child behaviors, and strategies to promote effective behavior management and healthy coping. Parents will also learn skills to manage their own emotional dysregulation to promote calm parental responding and promote healthy parent-child interaction and communication.
The PROACTIVE Parent model is ideally suited to promote parent's active management of child MH care. Children depend on parents to navigate a complex system of care and support children's coping in the home and community. However, parents may not know how to navigate appropriate treatments, how to communicate with their child's therapist to support treatment goals in the home, or how to interact with their child in a way that supports positive mental health outcomes. These parents require a service model that builds parent capacity to manage their child's MH care. The conceptual framework for the proposed work draws on the concept of parent activation and engagement in their child's MH care, and regulating affect. Activation refers to the parent's knowledge, capacity, and commitment to manage their child's MH care. Engagement refers to actions parents take to manage their child's care. Emotion regulation skills help parents to manage their affect, to engage in calm responding to children's needs and assist children in regulating affect.
PROACTIVE Parent is delivered in weekly 30-minute telehealth coaching sessions over the course of 10 weeks. Parent coaches use motivational interviewing and psychoeducation to improve parent activation and management of their child's MH care. Parent coaches provide parent-training and evidence-based skills training to promote effective parent behavior, healthy coping, and positive parent-child interaction. The parent coach will deliver the PROACTIVE Parent model via telehealth with supplemental online resources, using a publically available service referral system to connect parents to evidence-based treatments and MH providers if needed.
The investigators will recruit Foster Parents of youth in care aged 8 - 13 years, with symptoms or history of depression to examine acceptability, feasibility and preliminary effectiveness of the PROACTIVE Parent program.
The Aims of this project include an open trial, and exploration of the relationship between parent activation and youth MH outcomes.
Aim 1: Conduct a pilot study to test acceptability, utility, feasibility, and preliminary effectiveness. The primary outcomes include: 1) Acceptability, 2) Usefulness, and 3) Feasibility (all measured by post-session questions and post-intervention Customer Satisfaction Survey; Feasibility will also include number of people referred who meet eligibility, number of parents who enroll after referral, time to complete assessments). Aim 2: Assess the preliminary effectiveness of the model to improve parent activation, and empowerment. Aim 3: Assess the preliminary effectiveness to reduce the number, severity, and frequency of child MH symptoms and maladaptive behaviors. Aim 4: Assess preliminary effectiveness of improving parent scores on the DERS and barriers to treatment participation.
If the PROACTIVE Parent model demonstrates feasibility and effectiveness, it could serve as a model for scaling up to a population-based approach to MH treatment for all children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A service delivery model and telehealth methodology to deliver a combination of mental health evaluation of the child, motivational interviewing, transdiagnostic and evidence-based skills training (ST), and parent training (PT) to parents.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: PROACTIVE ParentParticipants in the Intervention Group will receive up to 10 sessions of the PROACTIVE Parent intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Foster parent of child aged 8 - 13 years old with mental health symptoms
- Has access to a device and internet to allow videoconferencing or phone coaching
Key exclusion criteria (3 listed)
- Not currently parenting a child with symptoms or history of depression
- Does not speak English
- Does not have access to a device and internet to allow videoconferencing or phone coaching
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 |
|---|---|---|
| PROACTIVE ParentPROACTIVE Parent will educate parents about their child's mental health symptoms and treatment, how to talk to the child's therapist to support treatment goals at home and in the community. PROACTIVE Parent will teach parents the function of child behavior, the role of symptomatology in child behaviors, and strategies to promote effective behavior management and healthy coping. Parents will also learn skills to manage their own emotional dysregulation to promote calm parental responding and promote healthy parent-child interaction and communication. | Behavioural | Intervention Group |
Primary outcome
Client Satisfaction Questionnaire
Time frame: baseline
The Client Satisfaction Questionnaire (CSQ) is an 8-item scale with response options ranging from 1 - 4. Total scores range from 8 -32. Higher scores indicate higher satisfaction. Assesses the extent to which parents found the intervention helpful, relevant, feasible, and effective.
Client Satisfaction Questionnaire
Time frame: 11 weeks
The Client Satisfaction Questionnaire (CSQ) is an 8-item scale with response options ranging from 1 - 4. Total scores range from 8 -32. Higher scores indicate higher satisfaction. Assesses the extent to which parents found the intervention helpful, relevant, feasible, and effective.
Parent-Patient Activation Measure - Mental Health
Time frame: baseline
The Parent-Patient Activation Measure - Mental Health measures parent activation, defined as the knowledge, ability, and confidence to manage their child's mental health care. It consists of 13 items on a 4-point Likert-type scale ranging from 1-4. Item scores are summed for a total composite score ranging from 13 -52. Composite scores are linearly transformed into scores ranging from 0 - 100. Higher scores indicate higher activation in managing their child's mental health care.
Parent-Patient Activation Measure - Mental Health
Time frame: 11 weeks
The Parent-Patient Activation Measure - Mental Health measures parent activation, defined as the knowledge, ability, and confidence to manage their child's mental health care. It consists of 13 items on a 4-point Likert-type scale ranging from 1-4. Item scores are summed for a total composite score ranging from 13 -52. Composite scores are linearly transformed into scores ranging from 0 - 100. Higher scores indicate higher activation in managing their child's mental health care.
Family Empowerment Scale
Time frame: baseline
The Family Empowerment Scale consists of 34-items and 3 subscales (1. Family, 2. Mental health services, 3. Community) designed to assess a parent's sense of empowerment in families of children with an emotional disorder. Response options range from 1 (not true at all) - 5 (very true). Total scores range from 34 - 170, with higher scores indicating higher levels of empowerment.
Family Empowerment Scale
Time frame: 11 weeks
The Family Empowerment Scale consists of 34-items and 3 subscales (1. Family, 2. Mental health services, 3. Community) designed to assess a parent's sense of empowerment in families of children with an emotional disorder. Response options range from 1 (not true at all) - 5 (very true). Total scores range from 34 - 170, with higher scores indicating higher levels of empowerment.
12 secondary outcomes
PROMIS Parent-Proxy Pediatric Anxiety Short Form 8a (PROMIS Anxiety)
Time frame: baseline
PROMIS Parent-Proxy Pediatric Anxiety Short Form 8a (PROMIS Anxiety)
Time frame: 11 weeks
PROMIS Parent-Proxy Pediatric Depressive Symptoms Short Form 8a (PROMIS Depressive)
Time frame: baseline
PROMIS Parent-Proxy Pediatric Depressive Symptoms Short Form 8a (PROMIS Depressive)
Time frame: 11 weeks
Pediatric Symptom Checklist - 17 (PSC-17)
Time frame: baseline
Pediatric Symptom Checklist - 17 (PSC-17)
Time frame: 11 weeks
Barriers to Treatment Participation Scale; subscales I - IV
Time frame: baseline
Barriers to Treatment Participation Scale; subscale V
Time frame: baseline
Barriers to Treatment Participation Scale; subscales I - IV
Time frame: 11 weeks
Barriers to Treatment Participation Scale; subscale V
Time frame: 11 weeks
Difficulties in Emotion Regulation Scale (DERS)
Time frame: baseline
Difficulties in Emotion Regulation Scale (DERS)
Time frame: 11 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No. We are concerned that parents will be less likely to participate if their individual participant data is to be shared. Particularly in communities of color, there is a history of exploitation in research.
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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.
Heather J Risser, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROACTIVE Parent in people with Mental Health Issue, run by Northwestern University 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 15 Mar 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Client Satisfaction Questionnaire (time frame: baseline). 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 15 Mar 2024; AzTrials last refreshed its copy on 2 Nov 2026.