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Clinical Trials/NCT05981690
NCT05981690
Completed
N/A

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

University of Reading1 site in 1 country10 target enrollmentJune 6, 2021
ConditionsOCD

Overview

Phase
N/A
Intervention
Not specified
Conditions
OCD
Sponsor
University of Reading
Enrollment
10
Locations
1
Primary Endpoint
Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 6, 2021
End Date
March 28, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kate Harvey

Professor Kate Harvey

University of Reading

Eligibility Criteria

Inclusion Criteria

  • 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

  • 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.

Outcomes

Primary Outcomes

Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS)

Time Frame: Change from pre-baseline phase, within one-week post-treatment, one-month follow-up

Diagnostic interview. Higher scores indicate higher severity of OCD

Secondary Outcomes

  • 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)
  • Session Rating Scale- SRS(Weekly during intervention phase; one month follow-up)
  • Items assessing parent knowledge of OCD, how to help their child, and confidence to help child(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(Weekly during 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)
  • Treatment acceptability questions(one month follow-up)

Study Sites (1)

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