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Effectiveness of a Tailored Occupational Therapy Intervention for Women With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Occupational Therapy Intervention for Women with ADHD
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Occupational Therapy

Eligibility Criteria

21 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Females aged 21-55 years
  • English-speaking
  • Self-reported ADHD

Exclusion Criteria:

  • Severe co-morbid condition such as an eating disorder, major depression, bipolar disorder, schizophrenia spectrum disorder, or substance use disorder

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Occupational Therapy for Women with ADHD

Control

Arm Description

7-week tailored intervention for women with ADHD who have difficulty carrying out student, worker, spousal, and parenting roles due to poor time management, organization of their physical environments, management of internal and external stressors, and regulation of internal and external stimulation. Implementation of organizational, time management, stress management, and sensory regulation strategies for the home, school/work, and community environments.

No treatment provided.

Outcomes

Primary Outcome Measures

Difference in Score on World Health Organization Adult ADHD Self-Report Scale between pre- and post-intervention
18-item, 5-point Likert scale that requires 5 minutes to complete

Secondary Outcome Measures

Difference in Score on Perceived Stress Scale between pre- and post-intervention
10-item, 5-point, self-report Likert scale that requires 5 minutes to complete
Difference in Score on Canadian Occupational Performance Measure
5-item, 10-point rating scale designed to be completed conjointly by a therapist and participant and takes approximately 10 minutes to complete

Full Information

First Posted
June 28, 2017
Last Updated
July 16, 2018
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03203928
Brief Title
Effectiveness of a Tailored Occupational Therapy Intervention for Women With ADHD
Official Title
Effectiveness of a Tailored Occupational Therapy Intervention for Women With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
January 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

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

5. Study Description

Brief Summary
Although woman are diagnosed with Attention-deficit hyperactivity disorder (ADHD) at a 1:3 ratio with men, recent research suggests that woman may experience the same levels of adult ADHD as men but are underdiagnosed because symptoms may be less severe and/or mistaken for anxiety and depression. Women with ADHD typically experience problems in managing worker, student, spousal, and parenting roles dues to disorganization, poor time management, difficulty regulating internal and external stressors, and difficulty maintaining daily schedules and routines. Intervention effectiveness research has largely focused on pharmacological treatment of ADHD symptoms; however, while such pharmacological treatment tends to enhance concentration and reduce motor restlessness, it does not address the skills needed to successfully carry out daily life roles and activities dependent upon time management, prioritization of tasks, and regulation of emotional responses within the home, school/work, and community environments. In this study, the investigators aim to determine whether a 7-week tailored occupational therapy intervention addressing organization, time management, stress management, and sensory regulation in the home, school/work, and community environments can increase satisfaction in desired daily life activities, and reduce ADHD symptoms and stress levels in women with ADHD.
Detailed Description
Attention-deficit hyperactivity disorder (ADHD) is believed to be neurologically based and characterized by enduring attentional problems, motor restlessness, and cognitive and motor impulsivity that impact one's ability to function optimally in daily life activities. ADHD is commonly diagnosed in childhood at a prevalence rate of 11% and a male to female ratio of 3:1. The prevalence of adult ADHD varies from 4 to 6% and it is estimated that two-thirds of adult ADHD disorders are extensions of childhood ADHD. Researchers have suggested that the male to female prevalence ratio is inaccurate and that females experience ADHD at similar levels to males but are underdiagnosed. While boys with ADHD are often identified by their teachers because of motor impulsivity and inattention, girls with ADHD who may experience attentional problems and impulsivity without significant hyperactivity, may fail to be identified by teachers as needing evaluation and treatment. Some studies have found that female children and adolescents who experience the ADHD symptoms of inattention, disorganization, poor time management, and distractibility are more likely to be misdiagnosed with depression and anxiety. When depression and anxiety occur in children and adolescents with undiagnosed ADHD symptoms, they may result from the inability to manage ADHD symptoms as they impact functional performance in the home, school, and community. Much of the research exploring ADHD has been devoted to children and adolescents. The research examining adult ADHD has thus far largely attempted to describe the phenomenon of adult ADHD. Research investigating intervention effectiveness for adult ADHD has primarily focused on pharmacological treatment. The small body of research examining non-pharmacological treatment has found moderate effectiveness for pharmacological intervention combined with cognitive behavioral therapy and psychoeducation. Missing from this body of literature is research specifically examining interventions for women with ADHD, who present symptoms that are both overlapping with and unique from their male counterparts. Studies have found that women with ADHD tend to have difficulty maintaining and succeeding in employment, school, and parenting and spousal roles. The ability to organize and implement tasks associated with each role, follow daily schedules and routines needed to support desired roles, prioritize and manage tasks in a timely manner, and regulate internal and external stressors to maintain consistent emotional responses may be difficult for with women with ADHD. In this study, the investigators aim to provide a 7-week tailored intervention for women with ADHD who have difficulty carrying out student, worker, spousal, and parenting roles due to poor time management, organization of their physical environments, management of internal and external stressors, and regulation of internal and external stimulation. This intervention effectiveness study will use randomization and control. Twenty-four women who self-report diagnoses of ADHD will be recruited to participate and randomly assigned to either the intervention group (n=12) or control group (n=12). The intervention group will receive the 6-week intervention; the control group will not receive intervention (bit will receive an organization toolkit at study end).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Occupational Therapy for Women with ADHD
Arm Type
Experimental
Arm Description
7-week tailored intervention for women with ADHD who have difficulty carrying out student, worker, spousal, and parenting roles due to poor time management, organization of their physical environments, management of internal and external stressors, and regulation of internal and external stimulation. Implementation of organizational, time management, stress management, and sensory regulation strategies for the home, school/work, and community environments.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment provided.
Intervention Type
Behavioral
Intervention Name(s)
Occupational Therapy Intervention for Women with ADHD
Intervention Description
The intervention will run for 7 weeks and consist of the following 1-hour sessions. Each intervention session will be facilitated by two CUMC occupational therapy students in each participant's home environment (or another environment of the participant's choosing such as the work or school environment). Implementation of organizational, time management, stress management, and sensory regulation strategies for the home, school/work, and community environments.
Primary Outcome Measure Information:
Title
Difference in Score on World Health Organization Adult ADHD Self-Report Scale between pre- and post-intervention
Description
18-item, 5-point Likert scale that requires 5 minutes to complete
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Difference in Score on Perceived Stress Scale between pre- and post-intervention
Description
10-item, 5-point, self-report Likert scale that requires 5 minutes to complete
Time Frame
baseline and 8 weeks
Title
Difference in Score on Canadian Occupational Performance Measure
Description
5-item, 10-point rating scale designed to be completed conjointly by a therapist and participant and takes approximately 10 minutes to complete
Time Frame
baseline and 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females aged 21-55 years English-speaking Self-reported ADHD Exclusion Criteria: Severe co-morbid condition such as an eating disorder, major depression, bipolar disorder, schizophrenia spectrum disorder, or substance use disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Gutman, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
American Psychiatric Association. (2013). Diagnostic and statistical manual of mentaldisorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
Results Reference
background
Citation
Centers for Disease Control and Prevention. (2017). Attention-deficit/hyperactivity disorder (ADHD). Retrieved from https://www.cdc.gov/ncbddd/adhd/data.html
Results Reference
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PubMed Identifier
24954823
Citation
Vande Voort JL, He JP, Jameson ND, Merikangas KR. Impact of the DSM-5 attention-deficit/hyperactivity disorder age-of-onset criterion in the US adolescent population. J Am Acad Child Adolesc Psychiatry. 2014 Jul;53(7):736-44. doi: 10.1016/j.jaac.2014.03.005. Epub 2014 Apr 23.
Results Reference
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PubMed Identifier
27329539
Citation
Jaconis M, Boyd SJ, Hartung CM, McCrea SM, Lefler EK, Canu WH. Sex differences in claimed and behavioral self-handicapping and ADHD symptomatology in emerging adults. Atten Defic Hyperact Disord. 2016 Dec;8(4):205-214. doi: 10.1007/s12402-016-0200-y. Epub 2016 Jun 21.
Results Reference
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PubMed Identifier
20837979
Citation
Coles EK, Slavec J, Bernstein M, Baroni E. Exploring the gender gap in referrals for children with ADHD and other disruptive behavior disorders. J Atten Disord. 2012 Feb;16(2):101-8. doi: 10.1177/1087054710381481. Epub 2010 Sep 13.
Results Reference
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PubMed Identifier
25317366
Citation
Quinn PO, Madhoo M. A review of attention-deficit/hyperactivity disorder in women and girls: uncovering this hidden diagnosis. Prim Care Companion CNS Disord. 2014;16(3):PCC.13r01596. doi: 10.4088/PCC.13r01596. Epub 2014 Oct 13.
Results Reference
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PubMed Identifier
24497125
Citation
Fredriksen M, Dahl AA, Martinsen EW, Klungsoyr O, Faraone SV, Peleikis DE. Childhood and persistent ADHD symptoms associated with educational failure and long-term occupational disability in adult ADHD. Atten Defic Hyperact Disord. 2014 Jun;6(2):87-99. doi: 10.1007/s12402-014-0126-1. Epub 2014 Feb 5.
Results Reference
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PubMed Identifier
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Citation
Biederman J, Fried R, Tarko L, Surman C, Spencer T, Pope A, Grossman R, McDermott K, Woodworth KY, Faraone SV. Memantine in the Treatment of Executive Function Deficits in Adults With ADHD. J Atten Disord. 2017 Feb;21(4):343-352. doi: 10.1177/1087054714538656. Epub 2016 Jul 28.
Results Reference
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PubMed Identifier
26536057
Citation
Philipsen A, Jans T, Graf E, Matthies S, Borel P, Colla M, Gentschow L, Langner D, Jacob C, Gross-Lesch S, Sobanski E, Alm B, Schumacher-Stien M, Roesler M, Retz W, Retz-Junginger P, Kis B, Abdel-Hamid M, Heinrich V, Huss M, Kornmann C, Burger A, Perlov E, Ihorst G, Schlander M, Berger M, Tebartz van Elst L; Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS) Consortium. Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Dec;72(12):1199-210. doi: 10.1001/jamapsychiatry.2015.2146. Erratum In: JAMA Psychiatry. 2016 Jan;73(1):90.
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Citation
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Results Reference
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Effectiveness of a Tailored Occupational Therapy Intervention for Women With ADHD

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