Staying Strong With Schools InterventionNCT02378051
Staying Strong With Schools - A School-Based Resilience Support Intervention for Military-Connected Children
A study testing Staying Strong with Schools Intervention in people with Staying Strong With Schools Intervention and Waitlist Control, run by Massachusetts General Hospital at 10 sites in United States.
Trial summary
The purpose of this study is to examine whether Staying Strong With Schools, a school-based intervention to support military-connected children, will be helpful for school professionals and military parents in supporting specific needs of this population of children. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Staying Strong With Schools Intervention, Waitlist Control
- What is being tested?
- Staying Strong with Schools Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2014to Jun 2016
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For school teachers: age 18 or older, employed as teacher in a participating school, willingness to participate in the intervention and able to participate in the informed consent process.
- For military-connected children: age < 18, and currently in grade 1 through 6, student in a participating school, at least one parent who currently serves, or had served in the military since 9/11/01, children without a participating classroom teacher will not receive teacher-rated assessments, but will not be excluded from the school based intervention, parent gives permission for child to participate.
- For military parents: male or female, age 18 or older, parent of a child enrolled in one of the participating schools, parent or co-parent currently serves, or had served in the military since 9/11/01, parent of a military-connected child that is eligible to participate, willing to participate, and able to give informed consent, and permission to release test scores, and have their child participate in SSWS, and self-report, parental and teachers' assessments.
Who cannot join
- For teachers: unable to attend the initial training, unable to participate in the informed consent process.
- For military-connected children: decline participation, determination by the principal or teacher that participation would not be in the military-connected child's best interest for any reason.
- For military parents: unable to participate in the informed consent process.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Community Charter School
Cambridge, Massachusetts, 02141
East Falmouth Elementary School
East Falmouth, Massachusetts, 02536
Morse Pond School
Falmouth, Massachusetts, 02540
Mullen-Hall School
Falmouth, Massachusetts, 02540
North Falmouth Elementary School
Falmouth, Massachusetts, 02556
Hyannis West Elementary School
Hyannis, Massachusetts, 02601
Barnstable United Elementary School
Marstons Mills, Massachusetts, 02648
West Villages Elementary School
Marstons Mills, Massachusetts, 02648
Teaticket Elementary School
Teaticket, Massachusetts, 02536
West Barnstable Elementary School
West Barnstable, Massachusetts, 02668
About this study
Official title: Staying Strong With Schools - A School-Based Resilience Support Intervention for Military-Connected Children: A Preliminary Examination of Efficacy
The purpose of this study is to examine whether Staying Strong With Schools, a school-based intervention to support military-connected children, will be helpful for school professionals and military parents in supporting specific needs of this population of children. As part of the partnership between three school districts in Massachusetts and the Red Sox Foundation and Massachusetts General Hospital Home Base Program, the investigators will examine the efficacy of a training delivered to these schools. The schools will be randomly divided into two groups (like a toss of a coin). Half of the schools will receive the training in 2014-2015, and the other half will be waitlisted and receive the training the following year (2015-2016). All participants (school teachers, military-connected children, and their parents) will be asked to complete questionnaires the first year. The investigators hypothesize that, compared to the control schools, at the end of the school year, SSWS schools will be associated with: (1) greater sense of competence and quality of relationships with military-connected children (MCC) among school professionals; (2) lower parental distress and increased parental sense of competence and general family functioning; and (3) increased social support, and fewer academic, emotional, and behavioral problems among MCC. The investigators hypothesize that an increase in school professionals' sense of competence in identifying and handling MCC's needs, increased quality of relationships with MCC, lower parental distress, increased parental sense of competence, and increased general family functioning will mediate the efficacy of SSWS on MCC's social support and psychosocial functioning.
- Being tested
- Staying Strong with Schools Intervention, Waitlist Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staying Strong with Schools InterventionBehavioural
- On-Site Training to Raise Awareness about the Stress of Parental Deployment and Review Resources Helpful in Promoting military-connected children (MCC)'s Resilience. A 60-minute training will be delivered by our Liaison Trainer on-site to school professionals at the beginning of the school year.
- Training and supervision of the Resilience Support Liaison (RSL). In each school receiving the Staying Strong with Schools intervention, we will train the guidance counselor to take on the role of a RSL. The RSL will develop for each MCC an individual resilience support plan that will outline the specific intervention components that will be applied for him/her.
Waitlist ControlOther
Receipt of an educational pamphlet outlining resources useful to support military-connected children distributed to all educators at the beginning of the school year.
| Study group | Role | What they receive |
|---|---|---|
| Staying Strong with Schools Intervention | Experimental | The Staying Strong with Schools Intervention includes: (a) a training of all school professionals, and (b) a year-long training and supervision of the school guidance counselor (RSL), by a Liaison-Trainer (LT). Receives: Behavioral: Staying Strong with Schools Intervention |
| Waitlist Control | Placebo comparator | The waitlist control schools will receive an educational pamphlet outlining resources useful to support military-connected children to be distributed to all educators at the beginning of the Year 1. They will then receive the Staying Strong with Schools Intervention in Year 2. Receives: Other: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Teachers' Sense of Efficacy Scale
Teachers' Sense of Efficacy is the beliefs in their capability to make a difference in student learning, to be able to get through even to students who are difficult or unmotivated. The Teacher Sense of Efficacy Scale asks teachers to assess their capability concerning instructional strategies, student engagement, and classroom management. It will assess teachers' sense of competence in handling military-connected children's needs.
Measured: up to two years
The Student-Teacher Relationship Scale
The Student-Teacher Relationship Scale (STRS) is widely used to examine teachers' relationships with young students in terms of closeness, conflict, and dependency. It will assess the quality of teachers' relationships with military-connected children.
Measured: up to two years
Secondary outcomes (5)
Parenting Sense of Competence Scale
The Parenting Sense of Competence scale measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 16 item Likert-scale questionnaire (on a 6 point scale ranging from strongly agree [1] to strongly disagree [6]), with nine questions under Satisfaction and seven under Efficacy. Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role.
Measured: up to two years
Depression, Anxiety and Stress Scale
Parental distress will be assessed using the 21-item self-report Depression, Anxiety and Stress Scale. Items each reflect a negative emotional symptom. Each of these is rated on a four-point Likert scale of frequency or severity of the participants' experiences over the last week with the intention of emphasizing states over traits. These scores ranged from 0, meaning that the client believed the item "did not apply to them at all", to 3 meaning that the client considered the item to "apply to them very much, or most of the time".
Measured: up to two years
McMaster Family Assessment Device
Family functioning will be assessed using the general functioning subscale of McMaster Family Assessment Device. The GF subscale consists of 12 questions to permit individuals to rate how well each statement describes their family by selecting among four responses: strongly agree, agree, disagree, strongly disagree.
Measured: up to two years
Behavior Assessment System for Children, Second Edition
Maladaptive and adaptive behaviors and self-perceptions will be assessed using the Behavior Assessment System for Children, Second Edition. In this study, parents will be the informants. This measure assesses child's behaviors in the school setting (Teacher Rating; TRS) as well as the home and community setting (Parent Rating; PRS) without substantial burden.
Measured: up to two years
Child and Adolescent Social Support Scale
Perceived social support will be assessed using the Child and Adolescent Social Support Scale. Subjects respond to items using a six-point scale, ranging from 1= "never," to 6 ="always."
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staying Strong With Schools InterventionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Bui, MD, PhD, Massachusetts General Hospital
- Investigators
- T.H. Eric Bui, MD, PhD, Principal investigator, Massachusetts General HospitalBonnie Ohye, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378051
- Sponsor's protocol ID
- 2014P000867
- Status last verified
- Jan 2017
- First submitted
- 15 Sep 2014
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staying Strong With Schools - A School-Based Resilience Support Intervention for Military-Connected Children: A Preliminary Examination of Efficacy
- ClinicalTrials.gov ID
- NCT02378051
- Acronym / sponsor ID
- 2014P000867
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Mar 2015 (estimated)
- 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 purpose of this study is to examine whether Staying Strong With Schools, a school-based intervention to support military-connected children, will be helpful for school professionals and military parents in supporting specific needs of this population of children. As part of the partnership between three school districts in Massachusetts and the Red Sox Foundation and Massachusetts General Hospital Home Base Program, the investigators will examine the efficacy of a training delivered to these schools. The schools will be randomly divided into two groups (like a toss of a coin). Half of the schools will receive the training in 2014-2015, and the other half will be waitlisted and receive the training the following year (2015-2016). All participants (school teachers, military-connected children, and their parents) will be asked to complete questionnaires the first year. The investigators hypothesize that, compared to the control schools, at the end of the school year, SSWS schools will be associated with: (1) greater sense of competence and quality of relationships with military-connected children (MCC) among school professionals; (2) lower parental distress and increased parental sense of competence and general family functioning; and (3) increased social support, and fewer academic, emotional, and behavioral problems among MCC. The investigators hypothesize that an increase in school professionals' sense of competence in identifying and handling MCC's needs, increased quality of relationships with MCC, lower parental distress, increased parental sense of competence, and increased general family functioning will mediate the efficacy of SSWS on MCC's social support and psychosocial functioning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staying Strong with Schools Intervention | Experimental | Behavioral: Staying Strong with Schools InterventionThe Staying Strong with Schools Intervention includes: (a) a training of all school professionals, and (b) a year-long training and supervision of the school guidance counselor (RSL), by a Liaison-Trainer (LT). |
| Waitlist Control | Placebo comparator | Other: Waitlist ControlThe waitlist control schools will receive an educational pamphlet outlining resources useful to support military-connected children to be distributed to all educators at the beginning of the Year 1. They will then receive the Staying Strong with Schools Intervention in Year 2. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- For school teachers: age 18 or older, employed as teacher in a participating school, willingness to participate in the intervention and able to participate in the informed consent process.
- For military-connected children: age < 18, and currently in grade 1 through 6, student in a participating school, at least one parent who currently serves, or had served in the military since 9/11/01, children without a participating classroom teacher will not receive teacher-rated assessments, but will not be excluded from the school based intervention, parent gives permission for child to participate.
- For military parents: male or female, age 18 or older, parent of a child enrolled in one of the participating schools, parent or co-parent currently serves, or had served in the military since 9/11/01, parent of a military-connected child that is eligible to participate, willing to participate, and able to give informed consent, and permission to release test scores, and have their child participate in SSWS, and self-report, parental and teachers' assessments.
Key exclusion criteria (3 listed)
- For teachers: unable to attend the initial training, unable to participate in the informed consent process.
- For military-connected children: decline participation, determination by the principal or teacher that participation would not be in the military-connected child's best interest for any reason.
- For military parents: unable to participate in the informed consent process.
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 |
|---|---|---|
| Staying Strong with Schools Intervention1. On-Site Training to Raise Awareness about the Stress of Parental Deployment and Review Resources Helpful in Promoting military-connected children (MCC)'s Resilience. A 60-minute training will be delivered by our Liaison Trainer on-site to school professionals at the beginning of the school year. 2. Training and supervision of the Resilience Support Liaison (RSL). In each school receiving the Staying Strong with Schools intervention, we will train the guidance counselor to take on the role of a RSL. The RSL will develop for each MCC an individual resilience support plan that will outline the specific intervention components that will be applied for him/her. | Behavioural | Staying Strong with Schools Intervention |
| Waitlist ControlReceipt of an educational pamphlet outlining resources useful to support military-connected children distributed to all educators at the beginning of the school year. | Other | Waitlist Control |
Primary outcome
The Teachers' Sense of Efficacy Scale
Time frame: up to two years
Teachers' Sense of Efficacy is the beliefs in their capability to make a difference in student learning, to be able to get through even to students who are difficult or unmotivated. The Teacher Sense of Efficacy Scale asks teachers to assess their capability concerning instructional strategies, student engagement, and classroom management. It will assess teachers' sense of competence in handling military-connected children's needs.
The Student-Teacher Relationship Scale
Time frame: up to two years
The Student-Teacher Relationship Scale (STRS) is widely used to examine teachers' relationships with young students in terms of closeness, conflict, and dependency. It will assess the quality of teachers' relationships with military-connected children.
5 secondary outcomes
Parenting Sense of Competence Scale
Time frame: up to two years
Depression, Anxiety and Stress Scale
Time frame: up to two years
McMaster Family Assessment Device
Time frame: up to two years
Behavior Assessment System for Children, Second Edition
Time frame: up to two years
Child and Adolescent Social Support Scale
Time frame: up to two years
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 10 Jan 2017.
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.
T.H. Eric Bui, MD, PhD principal investigator
Massachusetts General Hospital
Bonnie Ohye, PhD principal investigator
Massachusetts General Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staying Strong with Schools Intervention in people with Staying Strong With Schools Intervention and Waitlist Control, run by Massachusetts General Hospital at 10 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 3 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: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. 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?
The Teachers' Sense of Efficacy Scale (time frame: up to two years). 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 Jan 2017.