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

ADHD Clinical Trial

Official title:

COG FUN Intervention for ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792921
• Other study ID #: HMO-0576-12
• Status: Completed
• Phase: N/A
• First received: January 27, 2013
• Last updated: February 27, 2018
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: February 2018
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• COG - FUN

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Hahn-Markowitz J, Manor I, Maeir A. Effectiveness of cognitive-functional (Cog-Fun) intervention with children with attention deficit hyperactivity disorder: a pilot study. Am J Occup Ther. 2011 Jul-Aug;65(4):384-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ADHD parameters	Using Brief Questionnaire	Three assessment points - at recruitment, after 3 months and after 6 months.