Increasing Academic Success in Middle School Students With ADHD

Treatment as Usual Clinical Trial

— STAND  

Official title:

Increasing Academic Success in Middle School Students With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048579
• Other study ID #: R34MH092466-01A1
• Status: Completed
• Phase: N/A
• First received: January 27, 2014
• Last updated: February 8, 2016
• Start date: February 2012
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Broadly, the purpose of the proposed study is to test the efficacy of a parent-coordinated, parent-teen-teacher collaborative intervention for middle school students with ADHD and academic impairment (STAND; Supporting Teens' Academic Needs Daily). [This model was chosen because of its potential ability to promote treatment maintenance and generalizability across school years, because parents will be taught to implement, monitor, and adjust intervention components as needed. Key innovative components in the STAND intervention address previously reported treatment barriers: 1) a parent-delivered academic intervention to promote maintenance and generalization across school years, and to relieve some of the burden of intervention delivery from teachers, 2) motivational interviewing to address parent disengagement from and adolescent resistance to the treatment process, 3) multiple tailored options for home-school communication, including a web-based support system, to facilitate home-school communication, and 4) empowering parents by coaching them to effectively and tactfully involve teachers in the treatment planning and monitoring process in order to increase teachers' willingness to support the child's academic needs. To study the feasibility and preliminary efficacy of the STAND treatment model,] two cohorts of 42 middle school students with ADHD will be recruited (total N=84) and randomly assigned to participate in STAND or a treatment-as-usual monitoring group. All participants will complete intake, mid-treatment, post-treatment, [and follow-up] assessments designed to monitor academic functioning, [intervention feasibility, compliance, and satisfaction].

Aim 1: The proposed study will evaluate the efficacy, [maintenance, and cross-school year generalization] of a parent-teen-teacher collaborative intervention (Supporting Teens' Academic Needs Daily; STAND) vs. treatment as usual to increase the academic functioning of middle school students with ADHD. Intervention effects on ADHD symptomatology and impairment, grade-point-average (GPA), [organization, daily planner use], homework completion, teacher ratings of academic functioning and classroom behavior, and the parent-teen relationship will be examined.

Aim 2: The proposed study will examine the acceptability and feasibility of the STAND program. Parents and teens will report on [satisfaction, barriers to treatment participation, therapeutic alliance, and treatment credibility] throughout the intervention and follow-up period. [Therapists will also complete ratings of parent and adolescent engagement and compliance with treatment procedures] will be collected from participants in the program. Parent, teen, and teacher compliance with intervention procedures will also be measured in order to assess feasibility. Treatment fidelity measures will also be collected in order to measure clinician adherence to the manualized STAND procedures.

Aim 3: The proposed study will also explore ways to improve home-school communication during the middle school years. To this end, families will be given options regarding the modality of communication with teachers, and parent, teen, and teacher preferences for medium of intervention delivery will be examined (i.e., web-based, email, paper/pencil).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 16 Years

Eligibility

Inclusion Criteria:

• DSM-IV-TR ADHD Diagnosis; regular education placement in school; academic impairment

Exclusion Criteria:

• IQ<80; Autism or PDD diagnosis;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavior Therapy + MI Intervention (Supporting Teens' Academic Needs Daily)
• Treatment as Usual

Intervention

Behavioral:
• Behavior Therapy + Motivational Interviewing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade Point Average		One year	No
Secondary	Parent Rated Adolescent Academic Problems		One Year	No
Secondary	parent rated ADHD symptoms		one year	No