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

OCD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05981690
• Other study ID #: UREC 21/27
• Status: Completed
• Phase: N/A
• Start date: June 6, 2021
• Est. completion date: March 28, 2022

Study information

• Verified date: July 2023
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 28, 2022
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder
• OCD

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	UK

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Session Rating Scale- SRS	Therapeutic alliance/treatment acceptability. Higher scores indicate greater acceptability.	Weekly during intervention phase; one month follow-up
Secondary	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
Secondary	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
Secondary	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