Therapist Guided, Parent-led, Cognitive Behavioural Therapy (CBT) for Preadolescent Children With Obsessive Compulsive Disorder (OCD)

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

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

Official Title
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Therapist Guided, Parent-led, Cognitive Behavioural Therapy (CBT) for Preadolescent Children With Obsessive Compulsive Disorder (OCD)

Conditions
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OCD

Intervention / Treatment
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* Behavioral: Therapist guided, parent-led CBT for preadolescent children with OCD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children Inclusion criteria: Aged 5 to 12 years old (when parents/carers complete the baseline questionnaires). Diagnosis of OCD (identified from the ADIS-P). UK-resident. Parents Inclusion criteria: Parent/legal guardian of the child. UK resident. Exclusion Criteria: Children Exclusion criteria: Comorbid condition, which is likely to interfere with treatment delivery, for example: Established Autism Spectrum Condition (ASC). 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). Profound learning difficulty (evidenced by attending a specialist school). Risk and/or safeguarding concerns, which are paramount and would interfere with treatment delivery, for example: Suicidal intent. Recurrent or potentially life limiting self-harm. 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). If children have been prescribed psychotropic medication, the dosage must have been stable for two months. Children who are currently receiving other psychological support/interventions delivered by a mental health professional. Parents Exclusion criteria: Significant intellectual impairment that is likely to interfere with treatment delivery. Unable to access or understand written English language materials needed for the intervention.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Non concurrent multiple baseline design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapist guided, parent-led CBT for preadolescent children with OCD<br>6 to 8 sessions of therapist guided, parent-led CBT for preadolescent children with OCD | Behavioral: Therapist guided, parent-led CBT for preadolescent children with OCD<br>* This treatment was adapted from an existing evidence based therapist guided parent-led CBT intervention for preadolescent children with anxiety difficulties. It consists of 6 to 8 treatment individual treatment sessions where parents learn CBT techniques to apply at home with their child<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS) | Diagnostic interview. Higher scores indicate higher severity of OCD | Change from pre-baseline phase, within one-week post-treatment, one-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Disorder Interview Schedule - Parent Report (ADIS-P) | Diagnostic interview. Indicates presence/absence of anxiety, OCD, and externalising difficulties. Higher severity scores indicate greater severity of difficulties. | Change from pre-baseline phase, within one-week post-treatment, one-month follow-up | 
| Children's Obsessional Compulsive Inventory - Revised - Parent Report (ChOCI-R-P) | Symptom measure. Higher scores indicate greater OCD symptoms and impairment. | Weekly during baseline and intervention phase; one month follow up | 
| Family Accommodation Scale - FAS | Symptom measure. Higher scores indicate greater levels of family accommodation of OCD. | Weekly during baseline and intervention phase; one month follow up | 
| Goal Based Outcomes - GBOs | Families identify up to 3 personalised goals to work towards during the intervention. Goals are rated weekly by the parent form 0 (no goal progress) to 10 (goal achieved) | Weekly during intervention phase; one month follow up | 
| Session Rating Scale- SRS | Therapeutic alliance/treatment acceptability. Higher scores indicate greater acceptability. | Weekly during intervention phase; one month follow-up | 
| Treatment acceptability questions | Treatment acceptability. 6 questionnaire items on a Likert scale from strongly disagree to strongly agree. 4 open ended questions regarding treatment acceptability. | one month follow-up | 
| Items assessing parent knowledge of OCD, how to help their child, and confidence to help child | 3 questionnaire items devised by study authors to assess parents' report of their knowledge and confidence to help their child to overcome OCD. Items scored from 0 (no new learning) to 5 (learned a lot) | Weekly during baseline and intervention phase; one month follow up | 
| Items assessing how much children have learned new information about their fears/ability to cope in feared situations | 2 questionnaire items devised by study authors to assess parents' perceptions of whether their child had learned new information about their fears and their ability to cope in feared situations, without performing their compulsions. Items scored from 0 (no new learning) to 5 (learned a lot) | Weekly during intervention phase; one month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD, CBT, parent