search
Back to results

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

Primary Purpose

OCD

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Therapist guided, parent-led CBT for preadolescent children with OCD
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OCD focused on measuring OCD, CBT, parent

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Reading

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

6 to 8 sessions of therapist guided, parent-led CBT for preadolescent children with OCD

Outcomes

Primary Outcome Measures

Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS)
Diagnostic interview. Higher scores indicate higher severity of OCD

Secondary Outcome Measures

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.
Children's Obsessional Compulsive Inventory - Revised - Parent Report (ChOCI-R-P)
Symptom measure. Higher scores indicate greater OCD symptoms and impairment.
Family Accommodation Scale - FAS
Symptom measure. Higher scores indicate greater levels of family accommodation of OCD.
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)
Session Rating Scale- SRS
Therapeutic alliance/treatment acceptability. Higher scores indicate greater acceptability.
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.
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)
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)

Full Information

First Posted
July 18, 2023
Last Updated
July 31, 2023
Sponsor
University of Reading
search

1. Study Identification

Unique Protocol Identification Number
NCT05981690
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 6, 2021 (Actual)
Primary Completion Date
March 3, 2022 (Actual)
Study Completion Date
March 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OCD
Keywords
OCD, CBT, parent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non concurrent multiple baseline design
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapist guided, parent-led CBT for preadolescent children with OCD
Arm Type
Experimental
Arm Description
6 to 8 sessions of therapist guided, parent-led CBT for preadolescent children with OCD
Intervention Type
Behavioral
Intervention Name(s)
Therapist guided, parent-led CBT for preadolescent children with OCD
Intervention Description
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
Primary Outcome Measure Information:
Title
Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS)
Description
Diagnostic interview. Higher scores indicate higher severity of OCD
Time Frame
Change from pre-baseline phase, within one-week post-treatment, one-month follow-up
Secondary Outcome Measure Information:
Title
Anxiety Disorder Interview Schedule - Parent Report (ADIS-P)
Description
Diagnostic interview. Indicates presence/absence of anxiety, OCD, and externalising difficulties. Higher severity scores indicate greater severity of difficulties.
Time Frame
Change from pre-baseline phase, within one-week post-treatment, one-month follow-up
Title
Children's Obsessional Compulsive Inventory - Revised - Parent Report (ChOCI-R-P)
Description
Symptom measure. Higher scores indicate greater OCD symptoms and impairment.
Time Frame
Weekly during baseline and intervention phase; one month follow up
Title
Family Accommodation Scale - FAS
Description
Symptom measure. Higher scores indicate greater levels of family accommodation of OCD.
Time Frame
Weekly during baseline and intervention phase; one month follow up
Title
Goal Based Outcomes - GBOs
Description
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)
Time Frame
Weekly during intervention phase; one month follow up
Title
Session Rating Scale- SRS
Description
Therapeutic alliance/treatment acceptability. Higher scores indicate greater acceptability.
Time Frame
Weekly during intervention phase; one month follow-up
Title
Treatment acceptability questions
Description
Treatment acceptability. 6 questionnaire items on a Likert scale from strongly disagree to strongly agree. 4 open ended questions regarding treatment acceptability.
Time Frame
one month follow-up
Title
Items assessing parent knowledge of OCD, how to help their child, and confidence to help child
Description
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)
Time Frame
Weekly during baseline and intervention phase; one month follow up
Title
Items assessing how much children have learned new information about their fears/ability to cope in feared situations
Description
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)
Time Frame
Weekly during intervention phase; one month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate N Harvey, PhD
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Reading
City
Reading
State/Province
UK
ZIP/Postal Code
RG6 6BZ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not able to make individual participant data available to other researchers.

Learn more about this trial

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

We'll reach out to this number within 24 hrs