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

NCT05981690 | Completed

• 1 other identifier: UREC 21/27
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

OCD

Keywords

OCD; CBT; parent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Anxiety Disorder Interview Schedule - Parent Report (ADIS-P)

  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)

  Weekly during baseline and intervention phase; one month follow up

• Family Accommodation Scale - FAS

  Weekly during baseline and intervention phase; one month follow up

• Goal Based Outcomes - GBOs

  Weekly during intervention phase; one month follow up

• Session Rating Scale- SRS

  Weekly during intervention phase; one month follow-up

Study Arms (1)

Therapist guided, parent-led CBT for preadolescent children with OCD

EXPERIMENTAL

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

Interventions

Therapist guided, parent-led CBT for preadolescent children with OCD BEHAVIORAL

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

Therapist guided, parent-led CBT for preadolescent children with OCD

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children
• Aged 5 to 12 years old (when parents/carers complete the baseline questionnaires).
• Diagnosis of OCD (identified from the ADIS-P).
• UK-resident. Parents
• Parent/legal guardian of the child.
• UK resident.

You may not qualify if:

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

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

University of Reading

Reading, UK, RG6 6BZ, United Kingdom

Location

Study Officials

• Kate N Harvey, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Kate Harvey

Model Details: Non concurrent multiple baseline design

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 8, 2023
• Study Start: June 6, 2021
• Primary Completion: March 3, 2022
• Study Completion: March 28, 2022
• Last Updated: August 8, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)