Childhood Mental DisorderNCT06139874
Thrive Intervention in Schools
A study testing THRIVE and Parenting Wisely in people with Childhood Mental Disorder, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is designed to test the effectiveness and implementation of an early intervention therapy for children and their primary caregivers by using existing school counselors across several school districts. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Childhood Mental Disorder
- What is being tested?
- THRIVE and Parenting Wisely
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2024to 10 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Near the clinical threshold on the Teacher or Parent Report Form
- An active primary caregiver can be identified and is available to participate in the intervention (mother, father, grandparent or any adult in this role)
Who cannot join
- Autism
- Major neurological disorder
- Participating in active weekly individual or family therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Early Emotional Development Program
St Louis, Missouri, 63108
About this study
Official title: Promoting Emotional Development Among Young Children Facing Adversity: An Effectiveness Implementation Study in St. Louis Schools
This study is designed to test the effectiveness and implementation of an early intervention therapy for children and their primary caregivers by using existing school counselors across several school districts.
The intervention is a 6-8 week caregiver-child intervention (THRIVE) which will be conducted via video conference in the family's home (i.e., zoom), or within the school setting (or a combination of those 2 modalities depending upon feasibility for the family). THRIVE will be compared to an asynchronous on-line parenting education program, Parenting Wisely (PW). This online parenting course will be accessed at www.parentingwisely.com.
Read more
Existing school counselors will be trained in the delivery of THRIVE to 3-7 year old children (in preschool, kindergarten and first grade) and their primary caregivers. In addition to testing the effectiveness of THRIVE compared to PW, we will also compare two implementation strategies: THRIVE-Coached and THRIVE-Low Coached (LC). We will assess ongoing coaching of THRIVE trainees to increase therapist efficacy and adherence to the intervention (THRIVE-Coached). This will be compared to implementation of THRIVE with low supports (e.g. weekly supervision) provided only for the first case following the initial training (THRIVE-LC].
Compared to those randomized to PW, we expect children who receive THRIVE will have significantly better behavioral and socio-emotional outcomes. Caregivers who receive THRIVE will experience less parenting stress and depression, more optimism and will show more nurturing, emotional tolerance, and supportive caregiving.
Therapists in the THRIVE-Coached condition will deliver the intervention with higher achieved outcomes and find the intervention to be more acceptable than therapists in the THRIVE-LC condition. Therapists in the THRIVE-Coached condition will be more likely to plan to sustain the intervention following the completion of the study than those in the THRIVE-LC condition. Parents and children receiving THRIVE from therapists in the THRIVE-Coached condition will have better socio-emotional outcomes than those in the THRIVE-LC and PW conditions.
- Conditions
- Childhood Mental Disorder
- Being tested
- THRIVE, Parenting Wisely
- Keywords
- Preschool, Parent-Child Relationship, Emotion Development, Therapy, Prevention
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVEBehavioural
Early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention.
Parenting WiselyBehavioural
Online asynchronous parenting program.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE Coached | Experimental | Thrive is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. It will be delivered by school social workers/counselors. Following training in THRIVE, school therapists in this condition will receive ongoing weekly group supervision over the life of the study. Receives: Behavioral: THRIVE |
| THRIVE Low Coached | Experimental | Thrive is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. It will be delivered by school social workers/counselors. Following training in THRIVE, school therapists in this condition will receive weekly group supervision only during thier first THRIVE case. Receives: Behavioral: THRIVE |
| Parenting Wisely | Active comparator | Online asynchronous parenting training that parents will complete independently. Receives: Behavioral: Parenting Wisely |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Behavior Checklist
Measure of child psychopathology/impairment (emotional and behavioral functioning). Raw scores are converted into T-scores. The T-scores range from 50 to 100, with higher scores indicating more problematic behaviors. T-scores above 65 indicate psychiatric symptoms.
Measured: T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention) and T4 (12 weeks post intervention)
Secondary outcomes (4)
The Emotion Regulation Checklist
Measure of children's self-regulation that targets affective lability, intensity, valence, and flexibility. The total scores range from 24 to 96, with higher scores indicating better emotion regulation.
Measured: T1 (baseline), T3 (completion of intervention)
Coping with Children's Negative Emotions Scale
Measure of parental coping styles in response to children's negative emotions. It consists of six subscales: Distress Reactions, Punitive Reactions, Expressive Encouragement, Emotion-Focused Reactions, Problem-Focused Reactions, and Minimization Reactions. The scores of each subscale range from 12 to 84, with higher scores indicating a greater likelihood of the parent engaging the type of response measured by that subscale.
Measured: T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention)
Parenting Stress Index
Measure of potential dysfunctional parent-child relationships and severity of parenting stress. Higher scores indicate higher levels of stress.
Measured: T1 (baseline), T3 (completion of intervention)
Parent-Child Observed Interaction Coding
Objective ratings of the parent-child relationship functioning, parent emotion learning and child emotional competence.
Measured: T1 (baseline), T3 (completion of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start9 Aug 2024
- Primary completion10 Nov 2028 (estimated)
- Study completion10 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood Mental DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Luby, MD, Washington University School of Medicine
- Investigators
- Joan Luby, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139874
- Sponsor's protocol ID
- 202306092
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang S, Quinones H, Miller L, Luby J, Kohl PL. Implementation climate and readiness for the THRIVE intervention in school settings: a mixed methods study. Implement Sci Commun. 2026 Jun 11. doi: 10.1186/s43058-026-01006-w. Online ahead of print.
PubMed 42277967
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Emotional Development Among Young Children Facing Adversity: An Effectiveness Implementation Study in St. Louis Schools
- ClinicalTrials.gov ID
- NCT06139874
- Acronym / sponsor ID
- 202306092
- Conditions
- Childhood Mental Disorder
- Keywords
- Preschool, Parent-Child Relationship, Emotion Development, Therapy, Prevention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 10 Nov 2028 (estimated)
- Study completion
- 10 Nov 2028 (estimated)
- First posted
- 18 Nov 2023 (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.
This study is designed to test the effectiveness and implementation of an early intervention therapy for children and their primary caregivers by using existing school counselors across several school districts.
The intervention is a 6-8 week caregiver-child intervention (THRIVE) which will be conducted via video conference in the family's home (i.e., zoom), or within the school setting (or a combination of those 2 modalities depending upon feasibility for the family). THRIVE will be compared to an asynchronous on-line parenting education program, Parenting Wisely (PW). This online parenting course will be accessed at www.parentingwisely.com.
Existing school counselors will be trained in the delivery of THRIVE to 3-7 year old children (in preschool, kindergarten and first grade) and their primary caregivers. In addition to testing the effectiveness of THRIVE compared to PW, we will also compare two implementation strategies: THRIVE-Coached and THRIVE-Low Coached (LC). We will assess ongoing coaching of THRIVE trainees to increase therapist efficacy and adherence to the intervention (THRIVE-Coached). This will be compared to implementation of THRIVE with low supports (e.g. weekly supervision) provided only for the first case following the initial training (THRIVE-LC].
Compared to those randomized to PW, we expect children who receive THRIVE will have significantly better behavioral and socio-emotional outcomes. Caregivers who receive THRIVE will experience less parenting stress and depression, more optimism and will show more nurturing, emotional tolerance, and supportive caregiving.
Therapists in the THRIVE-Coached condition will deliver the intervention with higher achieved outcomes and find the intervention to be more acceptable than therapists in the THRIVE-LC condition. Therapists in the THRIVE-Coached condition will be more likely to plan to sustain the intervention following the completion of the study than those in the THRIVE-LC condition. Parents and children receiving THRIVE from therapists in the THRIVE-Coached condition will have better socio-emotional outcomes than those in the THRIVE-LC and PW conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THRIVE Coached | Experimental | Behavioral: THRIVEThrive is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. It will be delivered by school social workers/counselors. Following training in THRIVE, school therapists in this condition will receive ongoing weekly group supervision over the life of the study. |
| THRIVE Low Coached | Experimental | Behavioral: THRIVEThrive is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. It will be delivered by school social workers/counselors. Following training in THRIVE, school therapists in this condition will receive weekly group supervision only during thier first THRIVE case. |
| Parenting Wisely | Active comparator | Behavioral: Parenting WiselyOnline asynchronous parenting training that parents will complete independently. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Near the clinical threshold on the Teacher or Parent Report Form
- An active primary caregiver can be identified and is available to participate in the intervention (mother, father, grandparent or any adult in this role)
Key exclusion criteria (3 listed)
- Autism
- Major neurological disorder
- Participating in active weekly individual or family therapy
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 |
|---|---|---|
| THRIVEEarly intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. | Behavioural | THRIVE Coached, THRIVE Low Coached |
| Parenting WiselyOnline asynchronous parenting program. | Behavioural | Parenting Wisely |
Primary outcome
Child Behavior Checklist
Time frame: T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention) and T4 (12 weeks post intervention)
Measure of child psychopathology/impairment (emotional and behavioral functioning). Raw scores are converted into T-scores. The T-scores range from 50 to 100, with higher scores indicating more problematic behaviors. T-scores above 65 indicate psychiatric symptoms.
4 secondary outcomes
The Emotion Regulation Checklist
Time frame: T1 (baseline), T3 (completion of intervention)
Coping with Children's Negative Emotions Scale
Time frame: T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention)
Parenting Stress Index
Time frame: T1 (baseline), T3 (completion of intervention)
Parent-Child Observed Interaction Coding
Time frame: T1 (baseline), T3 (completion of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Derived from this study: PubMed 42277967Wang S, Quinones H, Miller L, Luby J, Kohl PL. Implementation climate and readiness for the THRIVE intervention in school settings: a mixed methods study. Implement Sci Commun. 2026 Jun 11. doi: 10.1186/s43058-026-01006-w. Online ahead of print.
- Early Emotional Development Program WebsiteLink provided by the sponsor.
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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.
Joan Luby, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE and Parenting Wisely in people with Childhood Mental Disorder, run by Washington University School of Medicine 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: enrolling by invitation, as of the sponsor's last update on 12 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Child Behavior Checklist (time frame: T1 (baseline), T2 (halfway through intervention), T3 (completion of intervention) and T4 (12 weeks post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06139874, which also lists 1 linked publication.
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 12 Mar 2026.