Anxiety DisordersNCT05777161
A Trial of Parent-coached Exposure Therapy for Children With Anxiety Disorders and OCD
A study testing Parent Coached Exposure Therapy - Individualized, Cognitive Behavior Therapy and Parent Coached Exposure Therapy - Group (removed from study) in people with Anxiety Disorders and Obsessive-Compulsive Disorder, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) and standard cognitive behavioral therapy (CBT) in treating childhood anxiety disorders and obsessive compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 7 to 75 years
- Conditions the study is for
- Anxiety Disorders, Obsessive-Compulsive Disorder
- What is being tested?
- Parent Coached Exposure Therapy - Individualized, Cognitive Behavior Therapy and Parent Coached Exposure Therapy - Group (removed from study)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2020to 30 Aug 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 7 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a DSM-5 anxiety disorder diagnosis, including generalized anxiety disorder, obsessive compulsive disorder, panic disorder, agoraphobia, separation anxiety disorder, social and specific phobias, as assessed on the relevant modules of the (MINI-Kids; (Sheehan et al., 2010) by study staff in the PADC.
- Be appropriate for the PADC standard outpatient therapy program, and be interested in starting outpatient therapy,
- Have the anxiety disorder as their primary diagnosis,
- If taking a selective serotonin reuptake inhibitor, SNRI, tricyclic, or antipsychotic medication, had no medication changes made at least 8 weeks prior to initiating participation in the study and agree to no changes during the 12 weeks of the study.
Who cannot join
- History of and/or current psychosis, autism, bipolar disorder, or current suicidality, or eating disorder as assessed during the initial clinical interview and all available clinical information.
- Current positive diagnosis in the child's caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit his/her ability to understand CBT and follow-through with treatment directives (based on clinical interview).
- Secondary diagnosis of oppositional defiant disorder or major depression of sufficient severity to prevent anxiety treatment.
- Severity of symptoms that warrant higher level of care (i.e. intensive, residential, IOP, inpatient)
- Family is unable to attend weekly sessions (i.e. geographical or scheduling barriers)
- History of good quality exposure or CBT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized-controlled Trial of Therapy for Children and Adolescents With Anxiety Disorders and Obsessive Compulsive Disorder (OCD)
The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) and standard cognitive behavioral therapy (CBT) in treating childhood anxiety disorders and obsessive compulsive disorder (OCD).
Read the detailed description
The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) through baseline comparisons, to compare effectiveness of individual PCET and individual standard cognitive behavioral therapy (CBT), to compare efficiency of individual PCET and individual standard CBT, to compare effectiveness of group intensive PCET, individual PCET, and individual standard CBT, and acceptability.
- Conditions
- Anxiety Disorders, Obsessive-Compulsive Disorder
- Being tested
- Parent Coached Exposure Therapy - Individualized, Cognitive Behavior Therapy, Parent Coached Exposure Therapy - Group (removed from study)
- Medical subject headings
- Anxiety Disorders, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Coached Exposure Therapy - IndividualizedBehavioural
Also called PCET-I
Subject and parent begin by working with a therapist to create an individualized fear hierarchy consisting of situations and stimuli that produce anxiety for the child, gradually progressing from less anxiety to more anxiety.
Cognitive Behavior TherapyBehavioural
Also called CBT
Subjects will work with a therapist using anxiety management strategies to address thoughts, feelings, and behaviors.
Parent Coached Exposure Therapy - Group (removed from study)Behavioural
Also called PCET
Subjects and parents will work in a group setting to receive exposure therapy consisting of situations and stimuli that produce anxiety for the child, gradually progressing from less anxiety to more anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Parent Coached Exposure Therapy-Individual (PCET-I) Group | Experimental | Subjects will receive six to 14 weekly sessions of individual Parent Coached Exposure Therapy Receives: Behavioral: Parent Coached Exposure Therapy - Individualized |
| Traditional Cognitive Behavior Therapy (CBT) Group | Active comparator | Subjects will receive 6 to 14 weekly sessions of individual Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavior Therapy |
| Parent Coached Exposure Therapy-5day Intensive (PCET-5day) Group (removed from study) | Experimental | Subjects will receive 5 day (nine sessions) of group-based Parent Coached Exposure Therapy delivered within a span of five days (Monday through Friday), followed by 5 weeks of self-care Receives: Behavioral: Parent Coached Exposure Therapy - Group (removed from study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom severity per blinded independent evaluator
Measured by the Clinical Global Impression Scale (GCI-S) rating of severity of psychopathology ranging from 1 (not at all ill) to 7 (extremely ill), with a score of 1 or 2 reflecting no to minimal symptoms
Measured: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Treatment efficiency
Number of appointments attended
Measured: post-treatment (approximately 14 weeks)
Secondary outcomes (3)
Change in anxiety symptoms per blinded independent evaluator
Pediatric Anxiety Rating Scale consisting of 5 items rated from 0 (no symptoms) to 5 (most severe) summed for a total score ranging from 0 (no symptoms) to 25 (most severe).
Measured: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Change in symptom severity per parent
Spence Children's Anxiety Scale parent-report consisting of 38 items rated from 0 (never) to 3 (always) summed to a total score of 0 (no symptoms) to 108 (most severe).
Measured: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Change in symptom severity per child
Spence Children's Anxiety Scale child-report consisting of 38 items rated from 0 (never) to 3 (always) summed to a total score of 0 (no symptoms) to 108 (most severe).
Measured: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start11 Nov 2020
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Whiteside, Mayo Clinic
- Investigators
- Stephen Whiteside, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777161
- Sponsor's protocol ID
- 20-008982
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Current upon request. Determining how to make data more easily accessible.
Publications
Whiteside SPH, Gloe LM, Biggs BK. Differentiating the Course of Symptom Improvement Between Two Treatments for Childhood Anxiety Disorders. J Clin Psychol. 2026 Aug;82(8):1142-1153. doi: 10.1002/jclp.70140. Epub 2026 Apr 10.
PubMed 41961062
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-controlled Trial of Therapy for Children and Adolescents With Anxiety Disorders and Obsessive Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT05777161
- Acronym / sponsor ID
- 20-008982
- Conditions
- Anxiety Disorders, Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 21 Mar 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.
The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) and standard cognitive behavioral therapy (CBT) in treating childhood anxiety disorders and obsessive compulsive disorder (OCD).
Detailed description
The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) through baseline comparisons, to compare effectiveness of individual PCET and individual standard cognitive behavioral therapy (CBT), to compare efficiency of individual PCET and individual standard CBT, to compare effectiveness of group intensive PCET, individual PCET, and individual standard CBT, and acceptability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parent Coached Exposure Therapy-Individual (PCET-I) Group | Experimental | Behavioral: Parent Coached Exposure Therapy - IndividualizedSubjects will receive six to 14 weekly sessions of individual Parent Coached Exposure Therapy |
| Traditional Cognitive Behavior Therapy (CBT) Group | Active comparator | Behavioral: Cognitive Behavior TherapySubjects will receive 6 to 14 weekly sessions of individual Cognitive Behavioral Therapy |
| Parent Coached Exposure Therapy-5day Intensive (PCET-5day) Group (removed from study) | Experimental | Behavioral: Parent Coached Exposure Therapy - Group (removed from study)Subjects will receive 5 day (nine sessions) of group-based Parent Coached Exposure Therapy delivered within a span of five days (Monday through Friday), followed by 5 weeks of self-care |
Who may qualify
- Ages
- 7 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Have a DSM-5 anxiety disorder diagnosis, including generalized anxiety disorder, obsessive compulsive disorder, panic disorder, agoraphobia, separation anxiety disorder, social and specific phobias, as assessed on the relevant modules of the (MINI-Kids; (Sheehan et al., 2010) by study staff in the PADC.
- Be appropriate for the PADC standard outpatient therapy program, and be interested in starting outpatient therapy,
- Have the anxiety disorder as their primary diagnosis,
- If taking a selective serotonin reuptake inhibitor, SNRI, tricyclic, or antipsychotic medication, had no medication changes made at least 8 weeks prior to initiating participation in the study and agree to no changes during the 12 weeks of the study.
Key exclusion criteria (6 listed)
- History of and/or current psychosis, autism, bipolar disorder, or current suicidality, or eating disorder as assessed during the initial clinical interview and all available clinical information.
- Current positive diagnosis in the child's caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit his/her ability to understand CBT and follow-through with treatment directives (based on clinical interview).
- Secondary diagnosis of oppositional defiant disorder or major depression of sufficient severity to prevent anxiety treatment.
- Severity of symptoms that warrant higher level of care (i.e. intensive, residential, IOP, inpatient)
- Family is unable to attend weekly sessions (i.e. geographical or scheduling barriers)
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 |
|---|---|---|
| Parent Coached Exposure Therapy - IndividualizedAlso: PCET-ISubject and parent begin by working with a therapist to create an individualized fear hierarchy consisting of situations and stimuli that produce anxiety for the child, gradually progressing from less anxiety to more anxiety. | Behavioural | Parent Coached Exposure Therapy-Individual (PCET-I) Group |
| Cognitive Behavior TherapyAlso: CBTSubjects will work with a therapist using anxiety management strategies to address thoughts, feelings, and behaviors. | Behavioural | Traditional Cognitive Behavior Therapy (CBT) Group |
| Parent Coached Exposure Therapy - Group (removed from study)Also: PCETSubjects and parents will work in a group setting to receive exposure therapy consisting of situations and stimuli that produce anxiety for the child, gradually progressing from less anxiety to more anxiety. | Behavioural | Parent Coached Exposure Therapy-5day Intensive (PCET-5day) Group (removed from study) |
Primary outcome
Change in symptom severity per blinded independent evaluator
Time frame: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Measured by the Clinical Global Impression Scale (GCI-S) rating of severity of psychopathology ranging from 1 (not at all ill) to 7 (extremely ill), with a score of 1 or 2 reflecting no to minimal symptoms
Treatment efficiency
Time frame: post-treatment (approximately 14 weeks)
Number of appointments attended
3 secondary outcomes
Change in anxiety symptoms per blinded independent evaluator
Time frame: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Change in symptom severity per parent
Time frame: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Change in symptom severity per child
Time frame: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
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 22 Mar 2023.
- Derived from this study: PubMed 41961062Whiteside SPH, Gloe LM, Biggs BK. Differentiating the Course of Symptom Improvement Between Two Treatments for Childhood Anxiety Disorders. J Clin Psychol. 2026 Aug;82(8):1142-1153. doi: 10.1002/jclp.70140. Epub 2026 Apr 10.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Current upon request. Determining how to make data more easily accessible.
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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.
Stephen Whiteside, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Coached Exposure Therapy - Individualized, Cognitive Behavior Therapy and Parent Coached Exposure Therapy - Group (removed from study) in people with Anxiety Disorders and Obsessive-Compulsive Disorder, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 6 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 22 Mar 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 States. 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?
Change in symptom severity per blinded independent evaluator (time frame: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05777161, which also lists 1 linked publication.
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 22 Mar 2023.