OCDNCT05981690
Therapist Guided, Parent-led, Cognitive Behavioural Therapy (CBT) for Preadolescent Children With Obsessive Compulsive Disorder (OCD)
A study testing Therapist guided, parent-led CBT for preadolescent children with OCD in people with OCD, run by University of Reading at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- OCD
- What is being tested?
- Therapist guided, parent-led CBT for preadolescent children with OCD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2021to 28 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- OCD
- Being tested
- Therapist guided, parent-led CBT for preadolescent children with OCD
- Keywords
- OCD, CBT, parent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist guided, parent-led CBT for preadolescent children with OCDBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Therapist guided, parent-led CBT for preadolescent children with OCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS)
Diagnostic interview. Higher scores indicate higher severity of OCD
Measured: 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)
Diagnostic interview. Indicates presence/absence of anxiety, OCD, and externalising difficulties. Higher severity scores indicate greater severity of difficulties.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Weekly during intervention phase; one month follow up
Session Rating Scale- SRS
Therapeutic alliance/treatment acceptability. Higher scores indicate greater acceptability.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: Weekly during intervention phase; one month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start6 Jun 2021
- Primary completion3 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OCDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non concurrent multiple baseline design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Harvey, University of Reading
- Investigators
- Kate N Harvey, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981690
- Sponsor's protocol ID
- UREC 21/27
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not able to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapist Guided, Parent-led, Cognitive Behavioural Therapy (CBT) for Preadolescent Children With Obsessive Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT05981690
- Acronym / sponsor ID
- UREC 21/27
- Conditions
- OCD
- Keywords
- OCD, CBT, parent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non concurrent multiple baseline design
| Arm | Type | Receives |
|---|---|---|
| Therapist guided, parent-led CBT for preadolescent children with OCD | Experimental | Behavioral: Therapist guided, parent-led CBT for preadolescent children with OCD6 to 8 sessions of therapist guided, parent-led CBT for preadolescent children with OCD |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- Children
- Comorbid condition, which is likely to interfere with treatment delivery, for example:
- Risk and/or safeguarding concerns, which are paramount and would interfere with treatment delivery, for example:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapist guided, parent-led CBT for preadolescent children with OCDThis 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 | Behavioural | Therapist guided, parent-led CBT for preadolescent children with OCD |
Primary outcome
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
8 secondary outcomes
Anxiety Disorder Interview Schedule - Parent Report (ADIS-P)
Time frame: 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)
Time frame: Weekly during baseline and intervention phase; one month follow up
Family Accommodation Scale - FAS
Time frame: Weekly during baseline and intervention phase; one month follow up
Goal Based Outcomes - GBOs
Time frame: Weekly during intervention phase; one month follow up
Session Rating Scale- SRS
Time frame: Weekly during intervention phase; one month follow-up
Treatment acceptability questions
Time frame: one month follow-up
Items assessing parent knowledge of OCD, how to help their child, and confidence to help child
Time frame: 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
Time frame: Weekly during intervention phase; one month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No. We are not able to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate N Harvey, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist guided, parent-led CBT for preadolescent children with OCD in people with OCD, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.