Clinical trial NCT01792921: Effectiveness of a Cognitive-functional (Cog-Fun) Intervention for Children With ADHD
Official title: COG FUN Intervention for ADHD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ADHD
Keywords: Age 7-10 years old
regular education system
no moderate or severe neurological and/or psychiatric disorders
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 107
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children age 7-10 years diagnosed with ADHD

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.


Eligibility 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

Primary outcomes:
measure: Change in ADHD parameters
timeFrame: Three assessment points - at recruitment, after 3 months and after 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
citation: 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. doi: 10.5014/ajot.2011.000901.