Does the identification and treatment of comorbid anxiety disorders in children with attention deficit hyperactivity disorder (ADHD) improve outcomes?

Does the identification and treatment of comorbid anxiety disorders in children with attention deficit hyperactivity disorder (ADHD) improve outcomes: pilot for a large-scale randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33930984

Enrollment

Registered

2013-10-02

Start date

2013-10-14

Completion date

Unknown

Last updated

2019-02-11

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

Conditions

Attention-deficit hyperactivity disorder (ADHD) and anxiety Mental and Behavioural Disorders Disturbance of activity and attention

Interventions

Cool Kids Program (intervention group): The intervention will be administered by a clinical child psychologist and a study-employed research assistant. The research assistant will rece

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Families of children aged 8-12 years who have previously participated in ADHD research at Murdoch Childrens Research Institute (MCRI) and have indicated an interest in hearing about future research. 2. Participants must live within a 40km radius of the Royal Children?s Hospital and have caregiver report of: 2.1. ADHD symptoms meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for ADHD (child also needs to have been previously diagnosed with ADHD by a paediatrician) 2.2. Anxiety symptoms meeting DSM-IV criteria for at least one of the following anxiety disorders: generalised anxiety disorder, separation anxiety disorder, or social phobia 3. 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

Exclusion criteria

Exclusion criteria: 1. Receiving specialised treatment for their anxiety from a psychologist or psychiatrist 2. Major illness or disability 3. Non-English speaking

Design outcomes

Primary

Measure	Time frame
Acceptability and feasibility will be measured at 4 months post-randomisation through: 1. Participant uptake of the intervention 2. Intervention session attendance 3. Rates of participant drop-out 4. Parent and child completed evaluation of the treatment program	—

Secondary

Measure	Time frame
Secondary child outcomes will be measured at 4 months post randomisation and include: 1. Anxiety diagnoses (Anxiety Disorders Interview Schedule for DSM-IV ? parent report) 2. Anxiety symptoms (Spence Child Anxiety Scale ? parent and child report; School Anxiety Scale ? teacher report) 3. ADHD symptoms (ADHD Rating Scale IV ? parent and teacher report) 4. Overall behaviour (Strengths and Difficulties Questionnaire ? parent and teacher report) 5. Quality of life (Pediatric Quality of Life Questionnaire 4.0 ? parent report) 6. Sleep problem ? none, mild, moderate, severe (parent report) 7. School attendance over the past 3 months (days late, days missed ? parent report) Secondary primary caregiver outcomes will be measured at 4 months post randomisation and include: 1. Mental health symptoms (Depression Anxiety Stress Scale) 2. Work attendance over the past 3 months (days late, days missed)	—

Measure

Time frame

Secondary child outcomes will be measured at 4 months post randomisation and include: 1. Anxiety diagnoses (Anxiety Disorders Interview Schedule for DSM-IV ? parent report) 2. Anxiety symptoms (Spence Child Anxiety Scale ? parent and child report; School Anxiety Scale ? teacher report) 3. ADHD symptoms (ADHD Rating Scale IV ? parent and teacher report) 4. Overall behaviour (Strengths and Difficulties Questionnaire ? parent and teacher report) 5. Quality of life (Pediatric Quality of Life Questionnaire 4.0 ? parent report) 6. Sleep problem ? none, mild, moderate, severe (parent report) 7. School attendance over the past 3 months (days late, days missed ? parent report) Secondary primary caregiver outcomes will be measured at 4 months post randomisation and include: 1. Mental health symptoms (Depression Anxiety Stress Scale) 2. Work attendance over the past 3 months (days late, days missed)

—

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026