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Effectiveness of a Cognitive-functional (Cog-Fun) Intervention for Children With ADHD

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ClinicalTrials.gov Identifier: NCT01792921
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
BERGER ITAI, Hadassah Medical Organization

Brief Summary:
Scientific Rationale: Many children with ADHD have serious difficulties in participation in daily occupations in their ecological settings. These difficulties have a pervasive negative impact on their everyday functioning and quality of life (QoL). Although pharmacological treatment has been proven effective in treating ADHD symptoms in many children, as have psychosocial interventions such as parent training, there is little evidence for integrative approaches that address the cognitive, volitional and social-environmental barriers to participation with this population. Although preliminary positive effects of a cognitive-function (Cog-Fun) treatment in occupational therapy on this population have been demonstrated, additional evidence is needed to confirm these initial findings. Methods: Initial results of our pilot study (N=17 children with ADHD) demonstrated significant moderate to large effects of Cog-Fun treatment, which targeted participation and executive functions in daily life. Significant effects were also found for a measure of self-efficacy and neuropsychological measures of attention, planning and organization. Parent ratings showed significant reduction of ADHD symptoms and improved QoL. The purpose of the current study is to replicate the pilot study findings in a randomized controlled trial. The study will be a randomized controlled trial with a crossover design, including 2 groups of children with ADHD attending elementary school and their parents. The research group (Group A, n=50) will receive three months of the Cog-Fun treatment, designed for a parent/child dyad and the control group (Group B, n=50) will be wait-listed and receive treatment after three months. Outcomes will include measures of participation, executive functions in daily life, child and parental self-efficacy, ADHD symptoms and QoL. The investigators expect to find a significant main effect of time (pre-post intervention), group (research vs. control) and a significant interaction effect (group x time) on executive and occupational outcome measures.

Condition or disease Intervention/treatment
ADHD Behavioral: COG - FUN

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Study Type : Observational
Actual Enrollment : 107 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: COG FUN Intervention for ADHD
Actual Study Start Date : April 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Group/Cohort Intervention/treatment
control waitlist Behavioral: COG - FUN



Primary Outcome Measures :
  1. Change in ADHD parameters [ Time Frame: Three assessment points - at recruitment, after 3 months and after 6 months. ]
    Using Brief Questionnaire



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Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children age 7-10 years diagnosed with ADHD
Criteria

Inclusion Criteria:

  • diagnosis of ADHD
  • 7-10 years old
  • regular education system
  • no moderate or severe neurological and/or psychiatric disorders

Exclusion Criteria:

  • moderate or severe neurological and/or psychiatric disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792921


Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel, 91240
Sponsors and Collaborators
Hadassah Medical Organization

Publications:
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Responsible Party: BERGER ITAI, Director, Neurocognitive Center HMO, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01792921    
Other Study ID Numbers: HMO-0576-12
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Keywords provided by BERGER ITAI, Hadassah Medical Organization:
Age 7-10 years old
regular education system
no moderate or severe neurological and/or psychiatric disorders