Clinical trial NCT05981690: Therapist Guided, Parent-led, Cognitive Behavioural Therapy (CBT) for Preadolescent Children With Obsessive Compulsive Disorder (OCD)
Official title: Therapist Guided, Parent-led, Cognitive Behavioural Therapy (CBT) for Preadolescent Children With Obsessive Compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OCD
Keywords: OCD
CBT
parent
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non concurrent multiple baseline design
Primary purpose: TREATMENT

Brief summary: This preliminary study aims to examine the outcomes from a therapist guided, parent-led, CBT treatment for preadolescent children (aged 5 to 12 years old) with OCD.

Specifically, this study aims to:

1. Examine outcomes for children who receive the therapist guided, parent-led, CBT treatment for preadolescent children with OCD.
2. Examine parents' experiences and views about the acceptability of the treatment approach.

Detailed description: This study adapted an existing therapist guided, parent-led CBT intervention for children with anxiety difficulties, to ensure suitability for preadolescent children with OCD.

This preliminary study aims to examine the outcomes from a therapist guided, parent-led, CBT treatment for preadolescent children (aged 5 to 12 years old) with OCD.

Specifically, this study aims to:

1. Examine outcomes for children who receive the therapist guided, parent-led, CBT treatment for preadolescent children with OCD.
2. Examine parents' experiences and views about the acceptability of the treatment approach.

Eligibility criteria: Inclusion Criteria:

Children

Inclusion criteria:

1. Aged 5 to 12 years old (when parents/carers complete the baseline questionnaires).
2. Diagnosis of OCD (identified from the ADIS-P).
3. UK-resident. Parents

Inclusion criteria:

1. Parent/legal guardian of the child.
2. UK resident.

Exclusion Criteria:

Children

Exclusion criteria:

1. Comorbid condition, which is likely to interfere with treatment delivery, for example:

   1. Established Autism Spectrum Condition (ASC).
   2. Suspected ASC (indicated by exceeding the threshold of 15 on the Social Communication Questionnaire and where a diagnosis of ASC has not been ruled out by a medical professional).
   3. Profound learning difficulty (evidenced by attending a specialist school).
2. Risk and/or safeguarding concerns, which are paramount and would interfere with treatment delivery, for example:

   1. Suicidal intent.
   2. Recurrent or potentially life limiting self-harm.
   3. Significant safeguarding concerns (i.e., if the child has a child protection plan and/or is on the child protection register, and/or the research team consider the child to be suffering, or likely to suffer, significant harm).
3. If children have been prescribed psychotropic medication, the dosage must have been stable for two months.
4. Children who are currently receiving other psychological support/interventions delivered by a mental health professional.

Parents

Exclusion criteria:

1. Significant intellectual impairment that is likely to interfere with treatment delivery.
2. Unable to access or understand written English language materials needed for the intervention.

Primary outcomes:
measure: Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS)
timeFrame: Change from pre-baseline phase, within one-week post-treatment, one-month follow-up
Secondary outcomes:
measure: Anxiety Disorder Interview Schedule - Parent Report (ADIS-P)
timeFrame: Change from pre-baseline phase, within one-week post-treatment, one-month follow-up
measure: Children's Obsessional Compulsive Inventory - Revised - Parent Report (ChOCI-R-P)
timeFrame: Weekly during baseline and intervention phase; one month follow up
measure: Family Accommodation Scale - FAS
timeFrame: Weekly during baseline and intervention phase; one month follow up
measure: Goal Based Outcomes - GBOs
timeFrame: Weekly during intervention phase; one month follow up
measure: Session Rating Scale- SRS
timeFrame: Weekly during intervention phase; one month follow-up
measure: Treatment acceptability questions
timeFrame: one month follow-up
measure: Items assessing parent knowledge of OCD, how to help their child, and confidence to help child
timeFrame: Weekly during baseline and intervention phase; one month follow up
measure: Items assessing how much children have learned new information about their fears/ability to cope in feared situations
timeFrame: Weekly during intervention phase; one month follow up
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: UK
Study officials:
affiliation: University of Reading
name: Kate N Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
References: