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ADHD/Me Bibliotherapy Study

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADH-Me Book and ADHD Informational Brochure
ADHD Informational Brochure Only
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

7 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English speaking
  • Meet ADHD criteria based on ADHD evaluation

Exclusion Criteria:

-

Sites / Locations

  • Center for ADHD, Cincinnati Childrens Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ADH-Me Book

No ADH-Me Book

Arm Description

Families in both conditions will be told that they are receiving additional reading materials to help them and their child better understand the ADHD condition and the available options for treating ADHD. Families in both groups will receive the "Understanding ADHD: Information for Parents About ADHD" brochure. Families assigned to this condition will also receive the ADH-Me! book. Written by a pediatrician and health literacy expert, ADH-Me! is an accessible, rhyming narrative that describes an empathetic journey from the perspective of a child learning to live and succeed with ADHD. The book is intended to help families know what to expect from diagnosis through all stages of treatment, while attempting to foster love and support.

Families in both conditions will be told that they are receiving additional reading materials to help them and their child better understand the ADHD condition and the available options for treating ADHD. Families in both groups will receive the "Understanding ADHD: Information for Parents About ADHD" brochure.

Outcomes

Primary Outcome Measures

ADHD Knowledge and Opinion Survey - Revised
The knowledge portion of the AKOS-R, which consists of 15 true/false items, was modified by the research team for the 7 to 10-year-old children that will participate in this study. The overall readability of the survey was reduced from a 6th grade to a 4th grade level.

Secondary Outcome Measures

Decision-Making Involvement Scale - Parent Report
The DMIS is a 30-item measure completed by parents that was developed to assess the degree to which children and adolescents (ages 8 to 19 years) are involved in decisions having to do with their chronic illness management.
Decision-Making Involvement Scale - Youth Report
The DMIS is a 30-item measure completed by children that was developed to assess the degree to which children and adolescents (ages 8 to 19 years) are involved in decisions having to do with their chronic illness management.

Full Information

First Posted
July 20, 2018
Last Updated
January 22, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT03620344
Brief Title
ADHD/Me Bibliotherapy Study
Official Title
The Effect of Bibliotherapy on Parent and Child Knowledge of ADHD and Treatment Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulty getting parents to complete follow-up assessments
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders of childhood. It affects approximately 8% of school aged children and is characterized by persistent symptoms of inattention and/or hyperactivity/impulsivity. Typical ADHD assessments primarily involve interviewing the parents and gathering rating scales from parents and teachers. Feedback regarding diagnosis, clinical conceptualization, and treatment recommendations is usually provided by the clinical staff to the child's parents in the absence of the child. Hence, the ADHD diagnosis and repercussions of that diagnosis are often left unexplained to the child. Research has shown that bibliotherapy is an effective educational tool that can be used to help parents discuss ADHD diagnosis and treatment with their child. The aim of this study is to conduct a randomized trial in which tools for parents who are getting their elementary-aged (7 to 10-year-old) children evaluated for ADHD are explored. The evaluations (N=60) will be conducted at the Center for ADHD at Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati, OH. Half of the families (n=30) will be randomly assigned to the intervention group, where they will be provided with the child-focused "ADH-Me!" book during the feedback session, and the remaining half will not receive it. All participants will receive a booklet with general information about ADHD and a list of recommendations from the clinicians. Approximately 3 months after their feedback sessions, follow-up surveys will be conducted via telephone to question the parents and children about their ADHD knowledge, as well as about whether they had followed up on the clinicians' recommendations. It is hypothesized that providing families with the ADH-Me! book will increase families' knowledge about ADHD and facilitate the family following up on treatment recommendations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADH-Me Book
Arm Type
Experimental
Arm Description
Families in both conditions will be told that they are receiving additional reading materials to help them and their child better understand the ADHD condition and the available options for treating ADHD. Families in both groups will receive the "Understanding ADHD: Information for Parents About ADHD" brochure. Families assigned to this condition will also receive the ADH-Me! book. Written by a pediatrician and health literacy expert, ADH-Me! is an accessible, rhyming narrative that describes an empathetic journey from the perspective of a child learning to live and succeed with ADHD. The book is intended to help families know what to expect from diagnosis through all stages of treatment, while attempting to foster love and support.
Arm Title
No ADH-Me Book
Arm Type
Sham Comparator
Arm Description
Families in both conditions will be told that they are receiving additional reading materials to help them and their child better understand the ADHD condition and the available options for treating ADHD. Families in both groups will receive the "Understanding ADHD: Information for Parents About ADHD" brochure.
Intervention Type
Other
Intervention Name(s)
ADH-Me Book and ADHD Informational Brochure
Intervention Description
"Understanding ADHD" information brochure published by American Academy of Pediatrics and a children's book about ADHD condition
Intervention Type
Other
Intervention Name(s)
ADHD Informational Brochure Only
Intervention Description
"Understanding ADHD" information brochure published by American Academy of Pediatrics
Primary Outcome Measure Information:
Title
ADHD Knowledge and Opinion Survey - Revised
Description
The knowledge portion of the AKOS-R, which consists of 15 true/false items, was modified by the research team for the 7 to 10-year-old children that will participate in this study. The overall readability of the survey was reduced from a 6th grade to a 4th grade level.
Time Frame
3 months after ADHD evaluation feedback session
Secondary Outcome Measure Information:
Title
Decision-Making Involvement Scale - Parent Report
Description
The DMIS is a 30-item measure completed by parents that was developed to assess the degree to which children and adolescents (ages 8 to 19 years) are involved in decisions having to do with their chronic illness management.
Time Frame
3 months after ADHD evaluation feedback session
Title
Decision-Making Involvement Scale - Youth Report
Description
The DMIS is a 30-item measure completed by children that was developed to assess the degree to which children and adolescents (ages 8 to 19 years) are involved in decisions having to do with their chronic illness management.
Time Frame
3 months after ADHD evaluation feedback session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking Meet ADHD criteria based on ADHD evaluation Exclusion Criteria: -
Facility Information:
Facility Name
Center for ADHD, Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share.

Learn more about this trial

ADHD/Me Bibliotherapy Study

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