SPACE: a Parent-based Treatment for Pediatric OCD

NCT06356090 | Recruiting DMC

• 1 other identifier: 2023.0322 - NL84369.018.23
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the parent-based treatment SPACE: Supportive Parenting for Anxious Childhood Emotions. The aim of this study is to investigate whether SPACE is effective in reducing family accommodation (FA) and OCD symptoms in children with a complex obsessive-compulsive disorder (OCD), that did not or cannot benefit from first line treatment.

Conditions

Obsessive-Compulsive Disorder; Obsessive-Compulsive Disorder in Children; Obsessive-Compulsive Disorder in Adolescence; Anxiety Disorders and Symptoms

Keywords

SPACE; Family Accommodation; OCD; Anxiety; Children & adolescents; Parent-only treatment

Outcome Measures

Primary Outcomes (5)

• (Change in) OCD severity

  Measured using the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS, a clinician rated semi-structured interview based on a combined parent and child-report). The CY-BOCS contains a severity scale and a symptom checklist. The symptom checklist assesses the current and past potential obsessive and compulsive experiences (indicated with 'yes' or 'no'). The severity scale consist of 5 items on obsession severity and 5 items on compulsion severity, rated on a Likert scale from 0 to 4. Higher scores represent more severity. The CY-BOCS Total Score is the sum of the obsession severity and compulsion severity items (range 0-40, with higher scores representing greater severity).

  Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint 0), Timepoint 2 (± 4 weeks after T1), Timepoint 3 (± 8 weeks after Timepoint 1), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)

• (Change in) family accommodation (parent report)

  Measured using the Family Accommodation Scale Anxiety (FASA, parent version). Items are rated on a Likert scale from 0 to 4, with higher scores representing more family accommodation.

  Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint 0), Timepoint 2 (± 4 weeks after T1), Timepoint 3 (± 8 weeks after T1), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)

• (Change in) Family accommodation (child report)

  Measured using the Family Accommodation Scale Anxiety - Child Rated (FASA-CR, child version). Items are rated on a Likert scale from 0 to 4, with higher scores representing more family accommodation.

  Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint 0), Timepoint 2 (± 4 weeks after T1), Timepoint 3 (± 8 weeks after T1), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)

• Daily (change in) OCD symptoms

  Measured using two self-developed visual slider scales (rated on a 0-10 scale) in a mobile app (parents and child-report). Higher scores indicate more perceived OCD symptoms and more time spent on OCD symptoms.

  6 months - Assessed 3 times a week during 6 months

• Daily (change in) family accommodation

  Measured using two self-developed visual slider scales (rated on a 0-10 scale) in a mobile app (parents and child-report). Higher scores indicate more perceived FA and more time spent on FA.

  6 months - Assessed 3 times a week during 6 months

Secondary Outcomes (9)

• Symptoms of child anxiety

  Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint0), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)

• Symptoms of child depression

  Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint0), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)

• Symptoms of autism

  Assessed at Timepoint 0 (start baseline)

• Quality of life (parent-report)

  Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)

• Quality of life (child-report)

  Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)

Other Outcomes (8)

• Demographic variables

  Assessed at Timepoint 0 (start baseline)

• Psychiatric DSM-5 diagnosis of the child

  Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)

• Parenting burden

  Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)

Study Arms (1)

SPACE treatment with random baselines

EXPERIMENTAL

Participants are randomly allocated to one of three baseline periods (4 weeks, 6 weeks or 8 weeks). Only the parents of the participating families receive the SPACE treatment (12 sessions across 12 weeks). After the SPACE treatment, there is a follow-up period of 6 month after baseline.

Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE)

Interventions

Supportive Parenting for Anxious Childhood Emotions (SPACE) BEHAVIORAL

SPACE is a parent-based treatment (parent-stand-alone treatment) for parents of youth with anxiety symptoms or OCD. The manualized treatment protocol contains 12 sessions, in which parents are taught to reduce family accommodation (FA) and to increase supportive responses to their child.

SPACE treatment with random baselines

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The child ages between 7 - 18 years old
• The child meets the DSM-5 criteria for OCD (as primary classification)
• The child did not benefit from psychological treatment for OCD (either followed 8 to 12 sessions of CBT or other psychotherapy), aborted treatment early or was unable/not motivated to receive treatment due to high levels of anxiety/OCD)
• At time of baseline still meets the clinical cut-off of 16 or higher for OCD on the Child Yale-Brown Obsessive Compulsive Scale \[CY-BOCS\].
• Psychiatric comorbidity is allowed, provided that OCD is the primary treatment target
• Parents report high levels of Family Accommodation (FA) at time of baseline (meeting the cut-off of 10 or higher on the Family Accommodation Scale Anxiety \[FASA\])
• Medication use is allowed. Selective serotonin reuptake inhibitors (SSRI) use (for OCD symptoms) is allowed as well, provided that the medication regime has been stable 4 weeks prior to participation and remains unchanged during participation.

You may not qualify if:

• The child needs inpatient treatment
• Acute suicidality
• Psychotic symptoms
• No participating parents
• Parents have insufficient mastery of the Dutch language
• Parents or child have an estimated IQ below 75

Sponsors & Collaborators

• Chaim Huijser: lead
• Levvel: collaborator

Study Sites (1)

Amsterdam UMC / Levvel (Academic centre for child & adolescent psychiatry)

Amsterdam, Netherlands

RECRUITING

Related Publications (2)

• Lebowitz ER, Marin C, Martino A, Shimshoni Y, Silverman WK. Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions. J Am Acad Child Adolesc Psychiatry. 2020 Mar;59(3):362-372. doi: 10.1016/j.jaac.2019.02.014. Epub 2019 Mar 7.

  PMID: 30851397 BACKGROUND

• Maric M, Werff V. Single-Case Experimental Designs in Clinical Intervention Research. Small Sample Size Solutions. 2020;102-111.

  BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• C. Huijser, Dr.

  Amsterdam UMC / Levvel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J.D.K. Veeger, MSc

CONTACT

+31681027462; j.d.k.veeger@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single case experimental design (SCED) with multiple baselines

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: April 10, 2024
• Study Start: November 23, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion and publication of the present study, data sharing can be requested.
• Access Criteria: Requests for data sharing will be assessed by the Principal Investigator.

Locations

NL (1)