Emotional DisturbancesNCT05466214
Systematic Efficacy Replication Study of Conjoint Behavioral Consultation in Elementary Schools
A study testing Conjoint Behavioral Consultation (CBC) in people with Emotional Disturbances, run by American Institutes for Research at 1 site in United States.
Trial summary
The purpose of this project is to conduct an impact evaluation of the Conjoint Behavioral Consulting (CBC) intervention under real-world conditions as an IES Efficacy Replication trial. CBC is a family-school partnership intervention proven efficacious for children with serious emotional and behavior problems. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Disturbances
- What is being tested?
- Conjoint Behavioral Consultation (CBC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to 30 Jun 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in kindergarten, Grade 1, Grade 2, Grade 3, or Grade 4 at recruitment
- Among the 12 students with the highest risk score on the Behavioral and Emotional Screening System 3 Behavioral and Emotional Screening System (BASC3-BESS) in the above grade span in their school (among those with parental consent for screening).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Madison Metropolitan School District
Madison, Wisconsin, 53703
Beth Vaade, 608-285-2673
Brianne Monahan, (608) 204-7801
About this study
The purpose of this project is to conduct an impact evaluation of the Conjoint Behavioral Consulting (CBC) intervention under real-world conditions as an IES Efficacy Replication trial. CBC is a family-school partnership intervention proven efficacious for children with serious emotional and behavior problems. The investigation will conduct a systematic efficacy replication of CBC to identify important process and context variables in need of attention prior to a CBC effectiveness study. School-based specialists (SBSs) will implement CBC and will be responsible for working directly with parents and teachers who have a student with or at risk for severe emotional disturbance, with more implementation support (i.e., non-routine conditions) than would be expected under routine conditions to ensure adequate fidelity of implementation. The research questions examine the impact of CBC, when implemented by SBSs, on student, parent, and teacher outcomes, as well its effect on mediational pathways. In addition, the research team will gather stakeholder feedback in focus groups to provide information about factors that stakeholders perceive as impeding or promoting CBC adoption, implementation, and sustainability.
Read the detailed description
Sixty schools will be recruited for this impact evaluation (20 from Madison Metropolitan School District, and 40 from Milwaukee Public Schools). The population for this evaluation will consist of the 12 children from grades k-4 in each participating school who demonstrate the highest levels of behavioral and/or emotional difficulties in school, based on teacher ratings on the BASC3-BESS screening (and whose families consent to participate in the evaluation). The total population for this evaluation will include 720 students. Baseline will take place at the beginning of the intervention school year, outcome 1 at the end of the intervention school year, and outcome 2 at the end of the subsequent school year. At all three timepoints, the research team will gather parent questionnaires (covering competence in problem solving, parenting strategies, parent-teacher relationships, and their child's social and behavioral functioning), teacher questionnaires in relation to each study child (covering the parent-teacher relationship, teacher competence in problem solving, and the student's social and behavioral functioning), direct observations of teacher and student behavior in the classroom, and student records related to discipline.
- Conditions
- Emotional Disturbances
- Being tested
- Conjoint Behavioral Consultation (CBC)
- Medical subject headings
- Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjoint Behavioral Consultation (CBC)Behavioural
Also called Teachers and Parents as Partners (TAPP)
Within the treatment group, CBC will be integrated into how a school-based specialist works with families and teachers of children with or at risk of severe emotional disturbance.
| Study group | Role | What they receive |
|---|---|---|
| CBC Treatment Group | Experimental | For this group, school staff who work with families and teachers to address student emotional and behavioral concerns will use the CBC model to do so. Receives: Behavioral: Conjoint Behavioral Consultation (CBC) |
| Control Group | No intervention | For this group, school staff who work with families and teachers to address student emotional and behavioral concerns will engage in business as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Externalizing Problems, Parent Report, Outcome 1
Change in children's norm-referenced t-scores on the Externalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Externalizing Problems, Teacher Report, Outcome 1
Change in children's norm-referenced t-scores on the Externalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Externalizing Problems, Parent Report, Outcome 2
Change in children's norm-referenced t-scores on the Externalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Externalizing Problems, Techer Report, Outcome 2
Change in children's norm-referenced t-scores on the Externalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Internalizing Problems, Parent Report, Outcome 1
Change in children's norm-referenced t-scores on the Internalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Internalizing Problems, Teacher Report, Outcome 1
Change in children's norm-referenced t-scores on the Internalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Internalizing Problems, Parent Report, Outcome 2
Change in children's norm-referenced t-scores on the Internalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Internalizing Problems, Teacher Report, Outcome 2
Change in children's norm-referenced t-scores on the Internalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Behavioral Symptoms, Parent Report, Outcome 1
Change in children's norm-referenced t-scores on the Behavioral Symptoms subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Behavioral Symptoms, Teacher Report, Outcome 1
Change in children's norm-referenced t-scores on the Behavioral Symptoms subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Behavioral Symptoms, Parent Report, Outcome 2
Change in children's norm-referenced t-scores on the Behavioral Symptoms subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Behavioral Symptoms, Teacher Report, Outcome 2
Change in children's norm-referenced t-scores on the Behavioral Symptoms subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Adaptive Skills, Parent Report, Outcome 1
Change in children's norm-referenced t-scores on the Adaptive Skills subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Adaptive Skills, Teacher Report, Outcome 1
Change in children's norm-referenced t-scores on the Adaptive Skills subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Adaptive Skills, Parent Report, Outcome 2
Change in children's norm-referenced t-scores on the Adaptive Skills subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Adaptive Skills, Teacher Report, Outcome 2
Change in children's norm-referenced t-scores on the Adaptive Skills subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child School Problems, Teacher Report, Outcome 1
Change in children's norm-referenced t-scores on the School Problems subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child School Problems, Teacher Report, Outcome 2
Change in children's norm-referenced t-scores on the School Problems subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Social Skills, Parent Report, Outcome 1
Change in children's norm-referenced t-scores on the Social Skills subscale of the Social Skills Improvement System Rating Scales, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Social Skills, Teacher Report, Outcome 1
Change in children's norm-referenced t-scores on the Social Skills subscale of the Social Skills Improvement System Rating Scales, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Social Skills, Parent Report, Outcome 2
Change in children's norm-referenced t-scores on the Social Skills subscale of the Social Skills Improvement System Rating Scales, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Social Skills, Teacher Report, Outcome 2
Change in children's norm-referenced t-scores on the Social Skills subscale of the Social Skills Improvement System Rating Scales, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Problem Behaviors, Parent Report, Outcome 1
Change in children's norm-referenced t-scores on the Problem Behaviors subscale of the Social Skills Improvement System Rating Scales, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Problem Behaviors, Teacher Report, Outcome 1
Change in children's norm-referenced t-scores on the Problem Behaviors subscale of the Social Skills Improvement System Rating Scales, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Problem Behaviors, Parent Report, Outcome 2
Change in children's norm-referenced t-scores on the Problem Behaviors subscale of the Social Skills Improvement System Rating Scales, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Problem Behaviors, Teacher Report, Outcome 2
Change in children's norm-referenced t-scores on the Problem Behaviors subscale of the Social Skills Improvement System Rating Scales, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Autism Behaviors, Parent Report, Outcome 1
Change in children's norm-referenced t-scores on the Autism Behaviors subscale of the Social Skills Improvement System Rating Scales, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Autism Behaviors, Teacher Report, Outcome 1
Change in children's norm-referenced t-scores on the Autism Behaviors subscale of the Social Skills Improvement System Rating Scales, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Child Autism Behaviors, Parent Report, Outcome 2
Change in children's norm-referenced t-scores on the Autism Behaviors subscale of the Social Skills Improvement System Rating Scales, parent report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Child Autism Behaviors, Teacher Report, Outcome 2
Change in children's norm-referenced t-scores on the Autism Behaviors subscale of the Social Skills Improvement System Rating Scales, teacher report version.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Parenting Strategies: Consistent Discipline, Outcome 1
Change in score for the Consistent Discipline subscale of the Parenting Strategies instrument. Scores are calculated based on the mean rating across 11 items, with possible mean scores ranging from 1-5.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Parenting Strategies: Consistent Discipline, Outcome 2
Change in score for the Consistent Discipline subscale of the Parenting Strategies instrument. Scores are calculated based on the mean rating across 11 items, with possible mean scores ranging from 1-5.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Parenting Strategies: Parental Acceptance, Outcome 1
Change in score for the Parental Acceptance subscale of the Parenting Strategies instrument. Scores are calculated based on the mean rating across 8 items, with possible mean scores ranging from 1-5.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Parenting Strategies: Parental Acceptance, Outcome 2
Change in score for the Parental Acceptance subscale of the Parenting Strategies instrument. Scores are calculated based on the mean rating across 8 items, with possible mean scores ranging from 1-5.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Parenting Strategies: Positive Reinforcement, Outcome 1
Change in score for the Positive Reinforcement subscale of the Parenting Strategies instrument. Scores are calculated based on the mean rating across 12 items, with possible mean scores ranging from 1-5.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Parenting Strategies: Positive Reinforcement, Outcome 2
Change in score for the Positive Reinforcement subscale of the Parenting Strategies instrument. Scores are calculated based on the mean rating across 12 items, with possible mean scores ranging from 1-5.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Teacher Strategies: Positive Strategies, Outcome 1
Change in score for the Positive Strategies subscale of the Teacher Strategies instrument. Scores are calculated based on the mean rating across 22 items, with possible mean scores ranging from 1-5.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Teacher Strategies: Inappropriate Strategies, Outcome 1
Change in score for the Inappropriate Strategies subscale of the Teacher Strategies instrument. Scores are calculated based on the mean rating across 9 items, with possible mean scores ranging from 1-5.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Parent-Teacher Relationship: Parent Perspective on Joining, Outcome 1
Change in score for the Joining subscale of the Parent-Teacher Relationship Scale II, parent version. Scores are calculated based on the mean rating across 19 items, with possible mean scores ranging from 1-5.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Parent-Teacher Relationship: Teacher Perspective on Joining, Outcome 1
Change in score for the Joining subscale of the Parent-Teacher Relationship Scale II, teacher version. Scores are calculated based on the mean rating across 19 items, with possible mean scores ranging from 1-5.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Parent-Teacher Relationship: Parent Perspective on Communication, Outcome 1
Change in score for the Communication subscale of the Parent-Teacher Relationship Scale, parent version. Scores are calculated based on the mean rating across 5 items, with possible mean scores ranging from 1-5.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Parent-Teacher Relationship: Teacher Perspective on Communication, Outcome 1
Change in score for the Communication subscale of the Parent-Teacher Relationship Scale, teacher version. Scores are calculated based on the mean rating across 5 items, with possible mean scores ranging from 1-5.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Parent Competence in Problem Solving, Outcome 1
Change in score for the Parent Competence in Problem Solving Scale. Scores are calculated based on the mean rating across 8 items, with possible mean scores ranging from 1-6.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Teacher Competence in Problem Solving, Outcome 1
Change in score for the Teacher Competence in Problem Solving Scale. Scores are calculated based on the mean rating across 8 items, with possible mean scores ranging from 1-6.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Parent Competence in Problem Solving, Outcome 2
Change in score for the Parent Competence in Problem Solving Scale. Scores are calculated based on the mean rating across 8 items, with possible mean scores ranging from 1-6.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Behavior Watch Student: Inappropriate Motor Activity, Outcome 1
Change in score for Inappropriate Motor Activity on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Behavior Watch Student: Inappropriate Motor Activity, Outcome 2
Change in score for Inappropriate Motor Activity on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Behavior Watch Student: Off Task, Outcome 1
Change in score for Off Task on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Behavior Watch Student: Off Task, Outcome 2
Change in score for Off Task on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Behavior Watch Student: On Task, Outcome 1
Change in score for On Task on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Behavior Watch Student: On Task, Outcome 2
Change in score for On Task on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Behavior Watch Student: Appropriate Interactions, Outcome 1
Change in score for Appropriate Interactions on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Behavior Watch Student: Appropriate Interactions, Outcome 2
Change in score for Appropriate Interactions on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Behavior Watch Teacher: Positive Tangible Consequences, Outcome 1
Change in score for Positive Tangible Consequences on the Behavior Watch observation tool, teacher version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Behavior Watch Teacher: Effective Command, Outcome 1
Change in score for Effective Command on the Behavior Watch observation tool, teacher version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Behavior Watch Teacher: Positive Attention, Outcome 1
Change in score for Positive Attention on the Behavior Watch observation tool, teacher version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Behavior Watch Teacher: Use of Reductive Techniques, Outcome 1
Change in score for Use of Reductive Techniques on the Behavior Watch observation tool, teacher version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Behavior Watch Teacher: Negative Attention, Outcome 1
Change in score for Use of Negative Attention on the Behavior Watch observation tool, teacher version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Measured: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start25 Oct 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisturbancesStudies 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
- Parallel groups
- Model description
- Conjoint Behavioral Consultation (CBC) is an indirect consultation process focused on ameliorating problematic behaviors associated with severe emotional disturbance through structured, data-based problem solving and collaborative, consistent implementation of evidence-based interventions across home and school settings, while simultaneously enhancing family-school partnerships.. In CBC, problems are identified, defined, analyzed, and treated through strengths-based, mutual, collaborative interactions between parents and teachers with the support of a consultant. Through CBC, parents and teachers are taught evidence-based procedures to address behavior problems in their respective settings. Parents and teachers assume complementary roles and shared responsibility for identifying student goals and addressing challenging behaviors.
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Institutes for Research
- Sponsor type
- University, hospital or other
- Collaborators
- Wisconsin Center for Education Research, University of Nebraska College of Education and Human Sciences
- Responsible party
- Principal investigator, Elizabeth Spier, American Institutes for Research
- Investigators
- Andy Garbacz, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466214
- Sponsor's protocol ID
- Systematic Efficacy CBC 2021
- Status last verified
- Feb 2023
- First submitted
- 5 Apr 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Efficacy Replication Study of Conjoint Behavioral Consultation in Elementary Schools
- ClinicalTrials.gov ID
- NCT05466214
- Acronym / sponsor ID
- Systematic Efficacy CBC 2021
- Conditions
- Emotional Disturbances
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- American Institutes for ResearchUniversity, hospital or other
- Collaborators
- Wisconsin Center for Education Research, University of Nebraska College of Education and Human Sciences
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 20 Jul 2022 (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.
The purpose of this project is to conduct an impact evaluation of the Conjoint Behavioral Consulting (CBC) intervention under real-world conditions as an IES Efficacy Replication trial. CBC is a family-school partnership intervention proven efficacious for children with serious emotional and behavior problems. The investigation will conduct a systematic efficacy replication of CBC to identify important process and context variables in need of attention prior to a CBC effectiveness study. School-based specialists (SBSs) will implement CBC and will be responsible for working directly with parents and teachers who have a student with or at risk for severe emotional disturbance, with more implementation support (i.e., non-routine conditions) than would be expected under routine conditions to ensure adequate fidelity of implementation. The research questions examine the impact of CBC, when implemented by SBSs, on student, parent, and teacher outcomes, as well its effect on mediational pathways. In addition, the research team will gather stakeholder feedback in focus groups to provide information about factors that stakeholders perceive as impeding or promoting CBC adoption, implementation, and sustainability.
Detailed description
Sixty schools will be recruited for this impact evaluation (20 from Madison Metropolitan School District, and 40 from Milwaukee Public Schools). The population for this evaluation will consist of the 12 children from grades k-4 in each participating school who demonstrate the highest levels of behavioral and/or emotional difficulties in school, based on teacher ratings on the BASC3-BESS screening (and whose families consent to participate in the evaluation). The total population for this evaluation will include 720 students. Baseline will take place at the beginning of the intervention school year, outcome 1 at the end of the intervention school year, and outcome 2 at the end of the subsequent school year. At all three timepoints, the research team will gather parent questionnaires (covering competence in problem solving, parenting strategies, parent-teacher relationships, and their child's social and behavioral functioning), teacher questionnaires in relation to each study child (covering the parent-teacher relationship, teacher competence in problem solving, and the student's social and behavioral functioning), direct observations of teacher and student behavior in the classroom, and student records related to discipline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Conjoint Behavioral Consultation (CBC) is an indirect consultation process focused on ameliorating problematic behaviors associated with severe emotional disturbance through structured, data-based problem solving and collaborative, consistent implementation of evidence-based interventions across home and school settings, while simultaneously enhancing family-school partnerships.. In CBC, problems are identified, defined, analyzed, and treated through strengths-based, mutual, collaborative interactions between parents and teachers with the support of a consultant. Through CBC, parents and teachers are taught evidence-based procedures to address behavior problems in their respective settings. Parents and teachers assume complementary roles and shared responsibility for identifying student goals and addressing challenging behaviors.
| Arm | Type | Receives |
|---|---|---|
| CBC Treatment Group | Experimental | Behavioral: Conjoint Behavioral Consultation (CBC)For this group, school staff who work with families and teachers to address student emotional and behavioral concerns will use the CBC model to do so. |
| Control Group | No intervention | –For this group, school staff who work with families and teachers to address student emotional and behavioral concerns will engage in business as usual. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Enrolled in kindergarten, Grade 1, Grade 2, Grade 3, or Grade 4 at recruitment
- Among the 12 students with the highest risk score on the Behavioral and Emotional Screening System 3 Behavioral and Emotional Screening System (BASC3-BESS) in the above grade span in their school (among those with parental consent for screening).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Conjoint Behavioral Consultation (CBC)Also: Teachers and Parents as Partners (TAPP)Within the treatment group, CBC will be integrated into how a school-based specialist works with families and teachers of children with or at risk of severe emotional disturbance. | Behavioural | CBC Treatment Group |
Primary outcome
Child Externalizing Problems, Parent Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Externalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Child Externalizing Problems, Teacher Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Externalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Child Externalizing Problems, Parent Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Externalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Child Externalizing Problems, Techer Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Externalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Child Internalizing Problems, Parent Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Internalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Child Internalizing Problems, Teacher Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Internalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Child Internalizing Problems, Parent Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Internalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Child Internalizing Problems, Teacher Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Internalizing Problems subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Child Behavioral Symptoms, Parent Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Behavioral Symptoms subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Child Behavioral Symptoms, Teacher Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Behavioral Symptoms subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Child Behavioral Symptoms, Parent Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Behavioral Symptoms subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Child Behavioral Symptoms, Teacher Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Behavioral Symptoms subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Child Adaptive Skills, Parent Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Adaptive Skills subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Child Adaptive Skills, Teacher Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Adaptive Skills subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Child Adaptive Skills, Parent Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Adaptive Skills subscale of the Behavior Assessment System for Children, Third Edition, parent report version.
Child Adaptive Skills, Teacher Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Adaptive Skills subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Child School Problems, Teacher Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the School Problems subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Child School Problems, Teacher Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the School Problems subscale of the Behavior Assessment System for Children, Third Edition, teacher report version.
Child Social Skills, Parent Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Social Skills subscale of the Social Skills Improvement System Rating Scales, parent report version.
Child Social Skills, Teacher Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Social Skills subscale of the Social Skills Improvement System Rating Scales, teacher report version.
Child Social Skills, Parent Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Social Skills subscale of the Social Skills Improvement System Rating Scales, parent report version.
Child Social Skills, Teacher Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Social Skills subscale of the Social Skills Improvement System Rating Scales, teacher report version.
Child Problem Behaviors, Parent Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Problem Behaviors subscale of the Social Skills Improvement System Rating Scales, parent report version.
Child Problem Behaviors, Teacher Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Problem Behaviors subscale of the Social Skills Improvement System Rating Scales, teacher report version.
Child Problem Behaviors, Parent Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Problem Behaviors subscale of the Social Skills Improvement System Rating Scales, parent report version.
Child Problem Behaviors, Teacher Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Problem Behaviors subscale of the Social Skills Improvement System Rating Scales, teacher report version.
Child Autism Behaviors, Parent Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Autism Behaviors subscale of the Social Skills Improvement System Rating Scales, parent report version.
Child Autism Behaviors, Teacher Report, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in children's norm-referenced t-scores on the Autism Behaviors subscale of the Social Skills Improvement System Rating Scales, teacher report version.
Child Autism Behaviors, Parent Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Autism Behaviors subscale of the Social Skills Improvement System Rating Scales, parent report version.
Child Autism Behaviors, Teacher Report, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in children's norm-referenced t-scores on the Autism Behaviors subscale of the Social Skills Improvement System Rating Scales, teacher report version.
Parenting Strategies: Consistent Discipline, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for the Consistent Discipline subscale of the Parenting Strategies instrument. Scores are calculated based on the mean rating across 11 items, with possible mean scores ranging from 1-5.
Parenting Strategies: Consistent Discipline, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in score for the Consistent Discipline subscale of the Parenting Strategies instrument. Scores are calculated based on the mean rating across 11 items, with possible mean scores ranging from 1-5.
Parenting Strategies: Parental Acceptance, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for the Parental Acceptance subscale of the Parenting Strategies instrument. Scores are calculated based on the mean rating across 8 items, with possible mean scores ranging from 1-5.
Parenting Strategies: Parental Acceptance, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in score for the Parental Acceptance subscale of the Parenting Strategies instrument. Scores are calculated based on the mean rating across 8 items, with possible mean scores ranging from 1-5.
Parenting Strategies: Positive Reinforcement, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for the Positive Reinforcement subscale of the Parenting Strategies instrument. Scores are calculated based on the mean rating across 12 items, with possible mean scores ranging from 1-5.
Parenting Strategies: Positive Reinforcement, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in score for the Positive Reinforcement subscale of the Parenting Strategies instrument. Scores are calculated based on the mean rating across 12 items, with possible mean scores ranging from 1-5.
Teacher Strategies: Positive Strategies, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for the Positive Strategies subscale of the Teacher Strategies instrument. Scores are calculated based on the mean rating across 22 items, with possible mean scores ranging from 1-5.
Teacher Strategies: Inappropriate Strategies, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for the Inappropriate Strategies subscale of the Teacher Strategies instrument. Scores are calculated based on the mean rating across 9 items, with possible mean scores ranging from 1-5.
Parent-Teacher Relationship: Parent Perspective on Joining, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for the Joining subscale of the Parent-Teacher Relationship Scale II, parent version. Scores are calculated based on the mean rating across 19 items, with possible mean scores ranging from 1-5.
Parent-Teacher Relationship: Teacher Perspective on Joining, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for the Joining subscale of the Parent-Teacher Relationship Scale II, teacher version. Scores are calculated based on the mean rating across 19 items, with possible mean scores ranging from 1-5.
Parent-Teacher Relationship: Parent Perspective on Communication, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for the Communication subscale of the Parent-Teacher Relationship Scale, parent version. Scores are calculated based on the mean rating across 5 items, with possible mean scores ranging from 1-5.
Parent-Teacher Relationship: Teacher Perspective on Communication, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for the Communication subscale of the Parent-Teacher Relationship Scale, teacher version. Scores are calculated based on the mean rating across 5 items, with possible mean scores ranging from 1-5.
Parent Competence in Problem Solving, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for the Parent Competence in Problem Solving Scale. Scores are calculated based on the mean rating across 8 items, with possible mean scores ranging from 1-6.
Teacher Competence in Problem Solving, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for the Teacher Competence in Problem Solving Scale. Scores are calculated based on the mean rating across 8 items, with possible mean scores ranging from 1-6.
Parent Competence in Problem Solving, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in score for the Parent Competence in Problem Solving Scale. Scores are calculated based on the mean rating across 8 items, with possible mean scores ranging from 1-6.
Behavior Watch Student: Inappropriate Motor Activity, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for Inappropriate Motor Activity on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Behavior Watch Student: Inappropriate Motor Activity, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in score for Inappropriate Motor Activity on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Behavior Watch Student: Off Task, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for Off Task on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Behavior Watch Student: Off Task, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in score for Off Task on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Behavior Watch Student: On Task, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for On Task on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Behavior Watch Student: On Task, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in score for On Task on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Behavior Watch Student: Appropriate Interactions, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for Appropriate Interactions on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Behavior Watch Student: Appropriate Interactions, Outcome 2
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Change in score for Appropriate Interactions on the Behavior Watch observation tool, student version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Behavior Watch Teacher: Positive Tangible Consequences, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for Positive Tangible Consequences on the Behavior Watch observation tool, teacher version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Behavior Watch Teacher: Effective Command, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for Effective Command on the Behavior Watch observation tool, teacher version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Behavior Watch Teacher: Positive Attention, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for Positive Attention on the Behavior Watch observation tool, teacher version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Behavior Watch Teacher: Use of Reductive Techniques, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for Use of Reductive Techniques on the Behavior Watch observation tool, teacher version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Behavior Watch Teacher: Negative Attention, Outcome 1
Time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Change in score for Use of Negative Attention on the Behavior Watch observation tool, teacher version. Scores are calculated based on the rate observed for intervals recorded, with a possible score of 0.0-1.0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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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.
Andy Garbacz, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conjoint Behavioral Consultation (CBC) in people with Emotional Disturbances, run by American Institutes for Research 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 0 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: status not confirmed, as of the sponsor's last update on 9 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Spier, PhD (202-285-8380, espier@air.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Externalizing Problems, Parent Report, Outcome 1 (time frame: Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)). The study lists 58 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 9 Feb 2023.