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

Study Overview

• Status: Completed
• Conditions: OCD
• Intervention / Treatment: Behavioral: Therapist guided, parent-led CBT for preadolescent children with OCD

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • UK
    • Reading, UK, United Kingdom, RG6 6BZ
      • University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapist guided, parent-led CBT for preadolescent children with OCD; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Reading
• Investigators: Principal Investigator: Kate N Harvey, PhD, University of Reading

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2021
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: OCD; CBT; parent
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: UREC 21/27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not able to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No