NCT02048579

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

January 27, 2014

Last Update Submit

February 8, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Grade Point Average

    One year

Secondary Outcomes (2)

  • Parent Rated Adolescent Academic Problems

    One Year

  • parent rated ADHD symptoms

    one year

Study Arms (2)

Treatment as Usual

NO INTERVENTION

Behavior Therap + Motivational Interviewing

EXPERIMENTAL

Supporting Teens' Academic Needs Daily Therapy program delivered to parents and teens

Behavioral: Behavior Therapy + Motivational Interviewing

Interventions

Also known as: Supporting Teens' Academic Needs Daily (STAND)
Behavior Therap + Motivational Interviewing

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • IQ\<80; Autism or PDD diagnosis;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Behavior TherapyMotivational Interviewing

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDirective CounselingCounselingMental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Margaret H Sibley, Ph.D.

    Florida International University

    PRINCIPAL INVESTIGATOR
  • Willam Pelham, Ph.D.

    Florida International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 29, 2014

Study Start

February 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 9, 2016

Record last verified: 2016-02