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Completed

NCT Number: NCT05981690

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.

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Key information

Conditions

OCD

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, UK, RG6 6BZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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 outcomes

  1. 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

  1. Anxiety Disorder Interview Schedule - Parent Report (ADIS-P)

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

    Diagnostic interview. Indicates presence/absence of anxiety, OCD, and externalising difficulties. Higher severity scores indicate greater severity of difficulties.

  2. Children's Obsessional Compulsive Inventory - Revised - Parent Report (ChOCI-R-P)

    Time frame: Weekly during baseline and intervention phase; one month follow up

    Symptom measure. Higher scores indicate greater OCD symptoms and impairment.

  3. Family Accommodation Scale - FAS

    Time frame: Weekly during baseline and intervention phase; one month follow up

    Symptom measure. Higher scores indicate greater levels of family accommodation of OCD.

  4. Goal Based Outcomes - GBOs

    Time frame: Weekly during intervention phase; one month follow up

    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)

  5. Session Rating Scale- SRS

    Time frame: Weekly during intervention phase; one month follow-up

    Therapeutic alliance/treatment acceptability. Higher scores indicate greater acceptability.

  6. Treatment acceptability questions

    Time frame: one month follow-up

    Treatment acceptability. 6 questionnaire items on a Likert scale from strongly disagree to strongly agree. 4 open ended questions regarding treatment acceptability.

  7. 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

    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)

  8. 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

    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)

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2023
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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