Social Emotional LearningNCT05147246
Scaling-Up of a Social Emotional Learning Curriculum in Uganda
A study testing ParentCorps-Professional Development (PD) in people with Social Emotional Learning and Social Emotional Competence, run by NYU Langone Health at 1 site in Uganda.
Trial summary
Teachers' social emotional learning/competence (SEL/SEC) can influence teachers' ability in developing healthy teacher-student relationship, managing classroom, implementing evidence-based SEL promotion strategies in classroom, and supporting students' parents. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Emotional Learning, Social Emotional Competence
- What is being tested?
- ParentCorps-Professional Development (PD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteUganda
- Study dates
- 1 Aug 2021to 25 Aug 2022
- 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
- The inclusion criteria for the school staff (teachers, head teachers) are: they must be in the recruited study schools and teaching in Pre-Primary to Primary 4 classrooms or holding the head teachers/administration leadership position in school. The inclusion criteria for Parent Leaders are: they must be at least 18 years old and have served as a Parent-Teacher-Association member or Parent Leader in the school for at least 1 year.
- The inclusion criteria for the PD program implementers are: they must have current employment with eligible partners (i.e., medical/mental health institutions, Teacher Training Colleges), with professional experiences in teacher training or mental health training.
- The inclusion criteria for parents are: caregivers must be at least 18 years old, their children must be enrolled in Pre-Primary or Primary 1 to 4 classes (or between 3 to 10 years old) in the recruited schools, and willing to have their child to be assessed by research staff. Parents and children will have diverse characteristics (e.g., randomly selected from school student lists). About 5% families will be randomly selected from the student lists. The proposed study will be open to both men and women caregivers.
Who cannot join
- Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Catalyzing Change in Education Through a Transformative Learning Collaborative: Scaling-Up of a Social Emotional Learning Curriculum in Uganda
Teachers' social emotional learning/competence (SEL/SEC) can influence teachers' ability in developing healthy teacher-student relationship, managing classroom, implementing evidence-based SEL promotion strategies in classroom, and supporting students' parents. Also, most SEL/SEC interventions have not considered gender equity. Given high prevalence of gender-based violence and high exposure to adverse environment for teachers in low income countries (LIC), which may lead them to greater risk for lower SEC, transforming current education system and considering gender equity and SEL/SEC promotion curriculum to both teachers and children is needed.
The goal of this project is to respond to this need by adapting a locally supported evidence-based-intervention (EBI) for children and further integrates SEL/SEC curriculum for teachers and gender equity component. The EBI to be adapted in this study is ParentCorps-Professional Development (PD), a school-based EBI that trains, empowers, and supports teachers to apply EBI strategies to promote child SEL/SEC and academic learning, and reduce behavioral problems. Two pilot implementation studies from prior work conducted in Uganda and Nepal have demonstrated feasibility, acceptability, usefulness, and efficacy of PD in diverse low resource contexts. PD has shown positive impacts on multiple-level, including positive changes on students' emotional regulation and social competency, teacher-student relationship, and classroom social emotion climate. The proposed research builds on prior positive evidence and further partner with policy and relevant stakeholders to integrate gender equity and teacher SEL/SEC curriculum into the PD (as the PD-Enhance) as well as to test scalable strategies to provide the enhanced PD curriculum at the system level.
- Being tested
- ParentCorps-Professional Development (PD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParentCorps-Professional Development (PD)Behavioural
PD is a school-based evidence-based-intervention (EBI) and preventive service provision model that supports teachers and school personnel to apply EBI strategies to promot young children's medical health in impoverished areas. Teachers and PTAs will participate in a 4-day training before the 1st school term. Teachers in the intervention condition will also receive 8 sessions (8 hours) of face-to-face group-based coaching during the 1st and 2nd terms. Coaching sessions are to help teachers apply EBI strategies in their classrooms, engage families, and develop competencies.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Schools - School Staff | Experimental | Not described Receives: Behavioral: ParentCorps-Professional Development (PD) |
| Intervention Schools - Parent-Child Pairs | Experimental | Not described Receives: Behavioral: ParentCorps-Professional Development (PD) |
| Wait-List Control Schools - School Staff | No intervention | Not described |
| Wait-List Control Schools - Parent-Child Pairs | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of school staff who displayed a change in teacher EBI practice
Measured: 4-6 months post-intervention
Change in Score on Social Competence Scale - Parent (SCP)
SCP is a 12-item measure that assesses a child's prosocial behaviors, communication skills, and self control. Each item states a behavior that a child may display in a social setting. The parent assesses how well each statement describes the child. Responses are coded on a 5-pt Likert scale: 0=not at all, 1=a little, 2=moderately well, 3=well, and 4=very well. The total score range is 0-48; the higher the score, the better the child is able to regulate his/her emotions.
Measured: Baseline, Month 4-6
Change in Score on Difficulties in Emotion Regulation Scale (DERS) - Teacher
DERS measures emotion dysregulation in an individual. The 18 items, 5 point scale (1=Almost Never, 2=Sometimes, 3=About Half the Time, 4=Most of the Time, 5=Almost Always) yield scores on (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 regulation strategies that are perceived to be effective for feeling better. The total score range is 18-90; higher scores suggest greater problems with emotion regulation.
Measured: Baseline, Month 4-6
Secondary outcomes (4)
Change in Score on Perceived Stress Scale (PSS) - Teacher
PSS is a 10-question scale that ask about one's feelings and thoughts during the last month. In each case, the teacher is asked to indicate by circling how often he/she felt or thought a certain way. Each question is reported on a 0 (never) - 4 (very often) scale. The total score range is 0-40; the higher the score, the more frequent one has felt stressed.
Measured: Baseline, Month 4-6
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anger - Short Form - Parent
This 5-item form assesses the pure domain of anger in child as reported by parents. The measure is completed by the parent to rate the severity of the child's anger during the past 7 days. Each item is rated on a 5-point scale (1=never to 5=always) with a total score range of 5-25 with higher scores indicating greater severity of anger.
Measured: Baseline, Month 4-6
Change in PROMIS - Anxiety - Short Form - Parents
This 8-item form assesses anxiety in child as reported by parents. The measure is completed by the parent to rate the severity of the child's anxiety during the past 7 days. Each item is rated on a 5-point scale (1=never to 5=always) with a total score range of 8-40 with higher scores indicating greater severity of anxiety.
Measured: Baseline, Month 4-6
Change in PROMIS - Depression - Short Form - Parents
This 6-item form assesses depression in child as reported by parents. The measure is completed by the parent to rate the severity of the i child's depression during the past 7 days. Each item is rated on a 5-point scale (1=never to 5=always) with a total score range of 6-30 with higher scores indicating greater severity of depression.
Measured: Baseline, Month 4-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start1 Aug 2021
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Emotional LearningStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keng-Yen Huang, PhD, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147246
- Sponsor's protocol ID
- 20-00816
- Status last verified
- Jan 2023
- First submitted
- 24 Nov 2021
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot trial of a scale-up model for evidence-based intervention implementation. Given a pilot nature, we are not planning to share the data as public available data. Interested researchers can contact research team for use of the data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catalyzing Change in Education Through a Transformative Learning Collaborative: Scaling-Up of a Social Emotional Learning Curriculum in Uganda
- ClinicalTrials.gov ID
- NCT05147246
- Acronym / sponsor ID
- 20-00816
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 7 Dec 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.
Teachers' social emotional learning/competence (SEL/SEC) can influence teachers' ability in developing healthy teacher-student relationship, managing classroom, implementing evidence-based SEL promotion strategies in classroom, and supporting students' parents. Also, most SEL/SEC interventions have not considered gender equity. Given high prevalence of gender-based violence and high exposure to adverse environment for teachers in low income countries (LIC), which may lead them to greater risk for lower SEC, transforming current education system and considering gender equity and SEL/SEC promotion curriculum to both teachers and children is needed.
The goal of this project is to respond to this need by adapting a locally supported evidence-based-intervention (EBI) for children and further integrates SEL/SEC curriculum for teachers and gender equity component. The EBI to be adapted in this study is ParentCorps-Professional Development (PD), a school-based EBI that trains, empowers, and supports teachers to apply EBI strategies to promote child SEL/SEC and academic learning, and reduce behavioral problems. Two pilot implementation studies from prior work conducted in Uganda and Nepal have demonstrated feasibility, acceptability, usefulness, and efficacy of PD in diverse low resource contexts. PD has shown positive impacts on multiple-level, including positive changes on students' emotional regulation and social competency, teacher-student relationship, and classroom social emotion climate. The proposed research builds on prior positive evidence and further partner with policy and relevant stakeholders to integrate gender equity and teacher SEL/SEC curriculum into the PD (as the PD-Enhance) as well as to test scalable strategies to provide the enhanced PD curriculum at the system level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention Schools - School Staff | Experimental | Behavioral: ParentCorps-Professional Development (PD) |
| Intervention Schools - Parent-Child Pairs | Experimental | Behavioral: ParentCorps-Professional Development (PD) |
| Wait-List Control Schools - School Staff | No intervention | – |
| Wait-List Control Schools - Parent-Child Pairs | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The inclusion criteria for the school staff (teachers, head teachers) are: they must be in the recruited study schools and teaching in Pre-Primary to Primary 4 classrooms or holding the head teachers/administration leadership position in school. The inclusion criteria for Parent Leaders are: they must be at least 18 years old and have served as a Parent-Teacher-Association member or Parent Leader in the school for at least 1 year.
- The inclusion criteria for the PD program implementers are: they must have current employment with eligible partners (i.e., medical/mental health institutions, Teacher Training Colleges), with professional experiences in teacher training or mental health training.
- The inclusion criteria for parents are: caregivers must be at least 18 years old, their children must be enrolled in Pre-Primary or Primary 1 to 4 classes (or between 3 to 10 years old) in the recruited schools, and willing to have their child to be assessed by research staff. Parents and children will have diverse characteristics (e.g., randomly selected from school student lists). About 5% families will be randomly selected from the student lists. The proposed study will be open to both men and women caregivers.
Key exclusion criteria (1 listed)
- Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.
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 |
|---|---|---|
| ParentCorps-Professional Development (PD)PD is a school-based evidence-based-intervention (EBI) and preventive service provision model that supports teachers and school personnel to apply EBI strategies to promot young children's medical health in impoverished areas. Teachers and PTAs will participate in a 4-day training before the 1st school term. Teachers in the intervention condition will also receive 8 sessions (8 hours) of face-to-face group-based coaching during the 1st and 2nd terms. Coaching sessions are to help teachers apply EBI strategies in their classrooms, engage families, and develop competencies. | Behavioural | Intervention Schools - Parent-Child Pairs, Intervention Schools - School Staff |
Primary outcome
Number of school staff who displayed a change in teacher EBI practice
Time frame: 4-6 months post-intervention
Change in Score on Social Competence Scale - Parent (SCP)
Time frame: Baseline, Month 4-6
SCP is a 12-item measure that assesses a child's prosocial behaviors, communication skills, and self control. Each item states a behavior that a child may display in a social setting. The parent assesses how well each statement describes the child. Responses are coded on a 5-pt Likert scale: 0=not at all, 1=a little, 2=moderately well, 3=well, and 4=very well. The total score range is 0-48; the higher the score, the better the child is able to regulate his/her emotions.
Change in Score on Difficulties in Emotion Regulation Scale (DERS) - Teacher
Time frame: Baseline, Month 4-6
DERS measures emotion dysregulation in an individual. The 18 items, 5 point scale (1=Almost Never, 2=Sometimes, 3=About Half the Time, 4=Most of the Time, 5=Almost Always) yield scores on (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 regulation strategies that are perceived to be effective for feeling better. The total score range is 18-90; higher scores suggest greater problems with emotion regulation.
4 secondary outcomes
Change in Score on Perceived Stress Scale (PSS) - Teacher
Time frame: Baseline, Month 4-6
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anger - Short Form - Parent
Time frame: Baseline, Month 4-6
Change in PROMIS - Anxiety - Short Form - Parents
Time frame: Baseline, Month 4-6
Change in PROMIS - Depression - Short Form - Parents
Time frame: Baseline, Month 4-6
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 19 Jan 2023.
- Individual participant dataSharing planned: No. This is a pilot trial of a scale-up model for evidence-based intervention implementation. Given a pilot nature, we are not planning to share the data as public available data. Interested researchers can contact research team for use of the data.
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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.
Keng-Yen Huang, PhD, MPH principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ParentCorps-Professional Development (PD) in people with Social Emotional Learning and Social Emotional Competence, run by NYU Langone Health at 1 site in Uganda.
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 1 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 19 Jan 2023. 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 Uganda. 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?
Number of school staff who displayed a change in teacher EBI practice (time frame: 4-6 months post-intervention). The study lists 3 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 19 Jan 2023.