NCT03203928

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

June 28, 2017

Last Update Submit

July 16, 2018

Conditions

Keywords

ADHDOccupational Therapy

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline and 8 weeks

Secondary Outcomes (2)

  • Difference in Score on Perceived Stress Scale between pre- and post-intervention

    baseline and 8 weeks

  • Difference in Score on Canadian Occupational Performance Measure

    baseline and 8 weeks

Study Arms (2)

Occupational Therapy for Women with ADHD

EXPERIMENTAL

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.

Behavioral: Occupational Therapy Intervention for Women with ADHD

Control

NO INTERVENTION

No treatment provided.

Interventions

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.

Occupational Therapy for Women with ADHD

Eligibility Criteria

Age21 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (10)

  • American Psychiatric Association. (2013). Diagnostic and statistical manual of mentaldisorders (5th ed.). Arlington, VA: American Psychiatric Publishing.

    BACKGROUND
  • Centers for Disease Control and Prevention. (2017). Attention-deficit/hyperactivity disorder (ADHD). Retrieved from https://www.cdc.gov/ncbddd/adhd/data.html

    BACKGROUND
  • 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.

    PMID: 24954823BACKGROUND
  • 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.

    PMID: 27329539BACKGROUND
  • 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.

    PMID: 20837979BACKGROUND
  • 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.

    PMID: 25317366BACKGROUND
  • 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.

    PMID: 24497125BACKGROUND
  • 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.

    PMID: 24970718BACKGROUND
  • 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.

    PMID: 26536057BACKGROUND
  • Fuller-Thomson E, Lewis DA, Agbeyaka SK. Attention-deficit/hyperactivity disorder casts a long shadow: findings from a population-based study of adult women with self-reported ADHD. Child Care Health Dev. 2016 Nov;42(6):918-927. doi: 10.1111/cch.12380. Epub 2016 Jul 20.

    PMID: 27439337BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sharon Gutman, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two group randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of rehabilitation and Regenerative Medicine

Study Record Dates

First Submitted

June 28, 2017

First Posted

June 29, 2017

Study Start

September 15, 2017

Primary Completion

January 10, 2018

Study Completion

January 10, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations