ADHD/Me Bibliotherapy Study

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

The Effect of Bibliotherapy on Parent and Child Knowledge of ADHD and Treatment Follow-up

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03620344
• Other study ID #: 2017-4815
• Status: Terminated
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2019
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

Inclusion Criteria:

• English speaking

• Meet ADHD criteria based on ADHD evaluation

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Other:
• ADH-Me Book and ADHD Informational Brochure
"Understanding ADHD" information brochure published by American Academy of Pediatrics and a children's book about ADHD condition
• ADHD Informational Brochure Only
"Understanding ADHD" information brochure published by American Academy of Pediatrics

Locations

Country	Name	City	State
United States	Center for ADHD, Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after ADHD evaluation feedback session
Secondary	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.	3 months after ADHD evaluation feedback session
Secondary	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.	3 months after ADHD evaluation feedback session