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Does the treatment of anxiety in children with ADHD improve outcomes?

Does the treatment of anxiety in children with ADHD improve outcomes? A large-scale randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN59518816
Enrollment
228
Registered
2015-09-29
Start date
2015-10-06
Completion date
Unknown
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Attention deficit hyperactivity disorder (ADHD) 2. Anxiety Mental and Behavioural Disorders 1. Attention deficit hyperactivity disorder (ADHD) 2. Anxiety

Interventions

Children in the intervention arm will receive 10 sessions of cognitive behavioural therapy delivered by study trained psychologists, while the control group will continue to access usual care for mana

Sponsors

Murdoch Childrens Research Institute (MCRI)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged 8 - 12 years 2. Caregiver report of ADHD symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for ADHD (child also needs to have been previously diagnosed with ADHD by a paediatrician) 3. Caregiver report of anxiety symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Separation Anxiety Disorder, Generalised Anxiety Disorder, or Social Phobia

Exclusion criteria

Exclusion criteria: 1. Receiving specialised treatment for anxiety from a psychologist or psychiatrist. Participants who are taking medication for anxiety can participate provided they are still experiencing significant anxiety symptoms and have been on stable medication for a minimum of six weeks. 2. Major illness or disability. 3. Non-English speaking Added 05/10/2016: 4. A score of 15 or greater on the Social Communication Questionnaire, a measure of autism symptoms

Design outcomes

Primary

MeasureTime frame
Parent report of whether the child meets criteria for an anxiety disorder (separation anxiety disorder, social phobia, or generalised anxiety disorder) 5 months post-randomisation measured by the Anxiety Disorders Interview Schedule for Children 5.

Secondary

MeasureTime frame
Secondary outcome measures as of 05/10/2016: 1. Anxiety: Parent and child report of child anxiety symptoms as measured by the Spence Child Anxiety Scale and the Child Anxiety Life Interference Scale; teacher report of anxiety symptoms as measured by the School Anxiety Scale (all measured at baseline, 5 and 12 months post randomisation). Parent report of whether the child meets criteria for an anxiety disorder (separation anxiety disorder, social phobia, or generalised anxiety disorder) 12 months post-randomisation measured by the Anxiety Disorders Interview Schedule for Children 5 2. ADHD symptoms as measured by the ADHD Rating Scale IV (parent and teacher report measured at baseline, 5 and 12 months post randomisation) 2. Psychosocial quality of life as measured by the CHU-9D (parent and child report measured at baseline, 5 and 12 months post randomisation) 3. Behaviour as measured by the Strengths and Difficulties Questionnaire (parent and teacher report measured at baseline, 5 and 12 months post randomisation) 4. Executive functioning as measured by the NIH cognitive toolbox (blinded, direct assessment at baseline, 5 and 12 months post randomisation) 5. Parent mental health as measured by the K6 (measured at baseline, 5 and 12 months post randomisation) 6. Parenting behaviours as measured by a series a questions from the Longitudinal Study of Australian Children (measured at baseline, 5 and 12 months post randomisation) Original secondary outcome measures: 1. Anxiety: Parent and child report of child anxiety symptoms as measured by the Spence Child Anxiety Scale and the Child Anxiety Life Interference Scale; teacher report of anxiety symptoms as measured by the School Anxiety Scale (all measured at baseline and 5 months post randomisation). 2. ADHD symptoms as measured by the ADHD Rating Scale IV (parent

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026