Systematic Efficacy Replication Study of Conjoint Behavioral Consultation in Elementary Schools

Emotional Disturbances Clinical Trial

Official title:

Systematic Efficacy Replication Study of Conjoint Behavioral Consultation in Elementary Schools

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05466214
• Other study ID #: Systematic Efficacy CBC 2021
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2023
• Source: American Institutes for Research
• Contact: Elizabeth Spier, PhD
• Phone: 202-285-8380
• Email: espier[@]air.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria: None

Related Conditions & MeSH terms

• Affective Symptoms
• Emotional Disturbances

Intervention

Behavioral:
• Conjoint Behavioral Consultation (CBC)
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.

Locations

Country	Name	City	State
United States	Madison Metropolitan School District	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
American Institutes for Research	University of Nebraska College of Education and Human Sciences, Wisconsin Center for Education Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 2 (approximately 19 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)
Primary	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.	Baseline/pre-intervention (beginning of school year 1) to end of school year 1 (approximately 7 months)