Psychosocial FunctioningNCT06578026
Developing Resilience Skills and Social Competence in Youth in a School Setting
A study testing Resilience Builder Program in people with Psychosocial Functioning, run by The Catholic University of America at 1 site in United States.
Trial summary
Our study aimed to answer the question: Can a resilience-based intervention improve the psychosocial and educational outcomes of students with psychosocial difficulties? We examined the effectiveness of a resilience-based group intervention, the Resilience Builder Program® (RBP), with students in low-SES school… Read more about this study
- Who is it for?
- Ages 9 to 11 years
- Conditions the study is for
- Psychosocial Functioning
- What is being tested?
- Resilience Builder Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2016to 13 Mar 2020
- 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 9 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- psychosocial deficits
Who cannot join
- psychosis
- extreme aggression
- autism
Trial locations and contacts
1 site in 1 country.
United States1 site
Montgomery County Public Schools
Rockville, Maryland, 20850
About this study
Our study aimed to answer the question: Can a resilience-based intervention improve the psychosocial and educational outcomes of students with psychosocial difficulties? We examined the effectiveness of a resilience-based group intervention, the Resilience Builder Program® (RBP), with students in low-SES school settings to determine if this treatment improves psychosocial and educational outcomes.
Read the detailed description
Enhancing resilience is valuable to youth from economically marginalized communities given that they often face greater challenges and hardships than their peers from more affluent communities.
Efforts to increase resilience skills in these youth are hampered because they disproportionately encounter barriers in access to mental health interventions. Implementing school-based services may be optimal to address these inequalities. This project explores the effectiveness of a school-based group intervention (the Resilience Builder Program®) related to resilience and academic functioning in a sample of children from economically marginalized communities. Students (N = 169) with social-emotional difficulties were recruited from five elementary schools and randomly assigned to participate in the Resilience Builder Program® (RBP) immediately or following a semester delay. Participants, their parents, and teachers completed measures of resilience and academic functioning. Repeated-measures analysis of variance compares groups across time (pre-, post-intervention) on psychosocial and academic outcomes.
- Conditions
- Psychosocial Functioning
- Being tested
- Resilience Builder Program
- Keywords
- resilience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience Builder ProgramBehavioural
The Resilience Builder Program® group therapy will meet for one class period once a week during the semester (12 sessions). The group aims to improve resilience skills: areas such as the ability to control emotions and behavior, social skills and interactions with peers, problem-solving skills, ability to be flexible in different situations, self-esteem, and optimistic thinking. The groups involve the group leader presenting a new topic and skill, the students discussing this topic and developing strategies associated with the skill, the students practicing the skill while getting feedback from the group leader, and a period focused on self-control strategies. A letter reviewing each session will be sent home to the parent/guardian each week. Also, each child will be asked to do an assignment between weekly sessions to help him/her practice new skills.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Received the Resilience Builder Program intervention Receives: Behavioral: Resilience Builder Program |
| Control | No intervention | Did not receive the Resilience Builder Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resiliency scales for children and adolescent (RSCA)
self-report of child's resilience; score 0-100; higher scores = stronger resilience
Measured: 1 month
Secondary outcomes (1)
Behavior assessment system for children, 2nd edition (BASC)
parent, child, and teacher report across varied psychosocial subscales; score 0-100; scores vary based on subscale, higher scores can indicate greater impairment or better functioning
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start16 Jun 2016
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial FunctioningStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of America
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brendan Rich, The Catholic University of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578026
- Sponsor's protocol ID
- 16-057
- Status last verified
- Aug 2024
- First submitted
- 24 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Resilience Skills and Social Competence in Youth in a School Setting
- ClinicalTrials.gov ID
- NCT06578026
- Acronym / sponsor ID
- 16-057
- Conditions
- Psychosocial Functioning
- Keywords
- resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- The Catholic University of AmericaUniversity, hospital or other
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 29 Aug 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.
Our study aimed to answer the question: Can a resilience-based intervention improve the psychosocial and educational outcomes of students with psychosocial difficulties? We examined the effectiveness of a resilience-based group intervention, the Resilience Builder Program® (RBP), with students in low-SES school settings to determine if this treatment improves psychosocial and educational outcomes.
Detailed description
Enhancing resilience is valuable to youth from economically marginalized communities given that they often face greater challenges and hardships than their peers from more affluent communities.
Efforts to increase resilience skills in these youth are hampered because they disproportionately encounter barriers in access to mental health interventions. Implementing school-based services may be optimal to address these inequalities. This project explores the effectiveness of a school-based group intervention (the Resilience Builder Program®) related to resilience and academic functioning in a sample of children from economically marginalized communities. Students (N = 169) with social-emotional difficulties were recruited from five elementary schools and randomly assigned to participate in the Resilience Builder Program® (RBP) immediately or following a semester delay. Participants, their parents, and teachers completed measures of resilience and academic functioning. Repeated-measures analysis of variance compares groups across time (pre-, post-intervention) on psychosocial and academic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Resilience Builder ProgramReceived the Resilience Builder Program intervention |
| Control | No intervention | –Did not receive the Resilience Builder Program |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- psychosocial deficits
Key exclusion criteria (3 listed)
- psychosis
- extreme aggression
- autism
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 |
|---|---|---|
| Resilience Builder ProgramThe Resilience Builder Program® group therapy will meet for one class period once a week during the semester (12 sessions). The group aims to improve resilience skills: areas such as the ability to control emotions and behavior, social skills and interactions with peers, problem-solving skills, ability to be flexible in different situations, self-esteem, and optimistic thinking. The groups involve the group leader presenting a new topic and skill, the students discussing this topic and developing strategies associated with the skill, the students practicing the skill while getting feedback from the group leader, and a period focused on self-control strategies. A letter reviewing each session will be sent home to the parent/guardian each week. Also, each child will be asked to do an assignment between weekly sessions to help him/her practice new skills. | Behavioural | Treatment |
Primary outcome
Resiliency scales for children and adolescent (RSCA)
Time frame: 1 month
self-report of child's resilience; score 0-100; higher scores = stronger resilience
1 secondary outcome
Behavior assessment system for children, 2nd edition (BASC)
Time frame: 1 month
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 29 Aug 2024.
- Individual participant dataSharing planned: No. No plans to share with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience Builder Program in people with Psychosocial Functioning, run by The Catholic University of America 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 1 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 29 Aug 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 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?
Resiliency scales for children and adolescent (RSCA) (time frame: 1 month). 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 29 Aug 2024.