Emotional ProblemParentKITNCT05341297
A Transdiagnostic Internet Intervention for Parents of Children With Anxiety and Depressive Symptoms
A study testing ParentKIT in people with Emotional Problem and Anxiety, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
The purpose of this study is to evaluate the efficacy of a transdiagnostic, parent-led, Internet-delivered intervention in reducing child and adolescent internalizing problems. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Emotional Problem, Anxiety, Depression
- What is being tested?
- ParentKIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteRomania
- Study dates
- 1 Mar 2022to 31 Aug 2023
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- parent of a child/ adolescent aged 6 to 14 years
- elevated internalizing problems
- have Internet access
Who cannot join
- undergoing psychotherapy/ pharmacological treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Parent-led Transdiagnostic Interventions for Child and Adolescent Anxiety and Depressive Disorders
The purpose of this study is to evaluate the efficacy of a transdiagnostic, parent-led, Internet-delivered intervention in reducing child and adolescent internalizing problems.
Read the detailed description
Anxiety and depressive symptoms are common in children and adolescents. There is substantial research indicating that transdiagnostic Internet interventions are effective for adults and children with anxiety and depressive disorders; however, there is limited research on the efficacy of such programs aimed at parents of children and adolescents with anxiety and depressive symptoms. This study aims to investigate the efficacy of a transdiagnostic Internet intervention for parents of children with elevated anxiety and depressive symptoms.
- Conditions
- Emotional Problem, Anxiety, Depression, Psychological Distress
- Being tested
- ParentKIT
- Keywords
- Internet intervention, transdiagnostic, parent-led intervention, internalizing problems, children, Rational emotive and behavioral therapy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParentKITBehavioural
The intervention is structured in 9 modules through which parents learn to identify and manage their children's anxiety and depressive symptoms. The Internet intervention is guided by two psychotherapists under supervision training in Cognitive Behavioral Therapy, trained by the first author on the treatment protocol.
| Study group | Role | What they receive |
|---|---|---|
| ParentKIT | Experimental | Transdiagnostic parent-led Internet-delivered intervention Participants in the experimental group will have access to the ParentKIT intervention. The intervention was developed based on existing Cognitive Behavioral Therapy/ Rational Emotive Behavior Therapy protocols for parents of children with internalizing problems. It consists of nine modules delivered over three weeks. Receives: Behavioral: ParentKIT |
| Waitlist | No intervention | Participants in the waitlist condition will have access to the program after 3 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the brief Revised Children's Anxiety and Depression Scale - parent version
Measure of child anxiety and depressive symptoms, as reported by parents. Scores range between 0 and 33; higher scores indicate higher anxiety and depressive symptoms.
Measured: Baseline, 3 weeks and follow-up at 1 month after treatment termination
Secondary outcomes (4)
Change in the Patient Health Questionnaire-4
Measure of anxiety and depressive symptoms - will be used to measure changes in parental distress. Scores range between 0 and 12. Higher scores indicate higher distress.
Measured: Baseline, 3 weeks and follow-up at 1 month after treatment termination
Change in the Parental Self-Efficacy Scale
Measure of parental self-efficacy in relationship to parenting practices that may decrease anxiety and depression risks for adolescents. Total scores range between and 9 and 36. Higher scores indicate higher parental self-efficacy.
Measured: Baseline, 3 weeks and follow-up at 1 month after treatment termination
Change in the Family Accommodation Scale
Measure of parental anxiety accommodations. Scores range between 0 and 52. Higher scores indicate higher parental anxiety accommodations.
Measured: Baseline, 3 weeks and follow-up at 1 month after treatment termination
Satisfaction with the intervention
Client satisfaction will be measured with Client Satisfaction Questionnaire, short form (Attkisson \& Zwick, 1982). Scores range from 8 to 32, with higher scores indicating greater satisfaction with the intervention.
Measured: 3 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Mar 2022
- Primary completion30 Jun 2023
- Study completion31 Aug 2023
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 Emotional ProblemStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Costina-Ruxandra Păsărelu, Babes-Bolyai University
- Investigators
- Costina R Păsărelu, Ph.D, Principal investigator, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341297
- Sponsor's protocol ID
- GTC 31371/2020
- Acronym
- ParentKIT
- Status last verified
- Sep 2023
- First submitted
- 11 Apr 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be uploaded after publication of the results.
Publications
Poetar CR, Dobrean A, Andersson G. Preliminary efficacy of a transdiagnostic parent-led internet-delivered intervention for children with anxiety and depressive symptoms: a pilot randomized controlled trial. Child Adolesc Psychiatry Ment Health. 2024 Mar 6;18(1):31. doi: 10.1186/s13034-024-00721-3.
PubMed 38448874
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Parent-led Transdiagnostic Interventions for Child and Adolescent Anxiety and Depressive Disorders
- ClinicalTrials.gov ID
- NCT05341297
- Acronym / sponsor ID
- ParentKIT / GTC 31371/2020
- Conditions
- Emotional Problem, Anxiety, Depression, Psychological Distress
- Keywords
- Internet intervention, transdiagnostic, parent-led intervention, internalizing problems, children, Rational emotive and behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 22 Apr 2022 (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 evaluate the efficacy of a transdiagnostic, parent-led, Internet-delivered intervention in reducing child and adolescent internalizing problems.
Detailed description
Anxiety and depressive symptoms are common in children and adolescents. There is substantial research indicating that transdiagnostic Internet interventions are effective for adults and children with anxiety and depressive disorders; however, there is limited research on the efficacy of such programs aimed at parents of children and adolescents with anxiety and depressive symptoms. This study aims to investigate the efficacy of a transdiagnostic Internet intervention for parents of children with elevated anxiety and depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ParentKIT | Experimental | Behavioral: ParentKITTransdiagnostic parent-led Internet-delivered intervention Participants in the experimental group will have access to the ParentKIT intervention. The intervention was developed based on existing Cognitive Behavioral Therapy/ Rational Emotive Behavior Therapy protocols for parents of children with internalizing problems. It consists of nine modules delivered over three weeks. |
| Waitlist | No intervention | –Participants in the waitlist condition will have access to the program after 3 weeks. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- parent of a child/ adolescent aged 6 to 14 years
- elevated internalizing problems
- have Internet access
Key exclusion criteria (1 listed)
- undergoing psychotherapy/ pharmacological treatment
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 |
|---|---|---|
| ParentKITThe intervention is structured in 9 modules through which parents learn to identify and manage their children's anxiety and depressive symptoms. The Internet intervention is guided by two psychotherapists under supervision training in Cognitive Behavioral Therapy, trained by the first author on the treatment protocol. | Behavioural | ParentKIT |
Primary outcome
Change in the brief Revised Children's Anxiety and Depression Scale - parent version
Time frame: Baseline, 3 weeks and follow-up at 1 month after treatment termination
Measure of child anxiety and depressive symptoms, as reported by parents. Scores range between 0 and 33; higher scores indicate higher anxiety and depressive symptoms.
4 secondary outcomes
Change in the Patient Health Questionnaire-4
Time frame: Baseline, 3 weeks and follow-up at 1 month after treatment termination
Change in the Parental Self-Efficacy Scale
Time frame: Baseline, 3 weeks and follow-up at 1 month after treatment termination
Change in the Family Accommodation Scale
Time frame: Baseline, 3 weeks and follow-up at 1 month after treatment termination
Satisfaction with the intervention
Time frame: 3 weeks after treatment initiation
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 13 Sep 2023.
- Derived from this study: PubMed 38448874Poetar CR, Dobrean A, Andersson G. Preliminary efficacy of a transdiagnostic parent-led internet-delivered intervention for children with anxiety and depressive symptoms: a pilot randomized controlled trial. Child Adolesc Psychiatry Ment Health. 2024 Mar 6;18(1):31. doi: 10.1186/s13034-024-00721-3.
- Individual participant dataSharing planned: Yes. De-identified data will be uploaded after publication of the results.
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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.
Costina R Păsărelu, Ph.D principal investigator
Babes-Bolyai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ParentKIT in people with Emotional Problem and Anxiety, run by Babes-Bolyai University at 1 site in Romania.
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 3 inclusion and 1 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 13 Sep 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 Romania. 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 the brief Revised Children's Anxiety and Depression Scale - parent version (time frame: Baseline, 3 weeks and follow-up at 1 month after treatment termination). 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 NCT05341297, 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 13 Sep 2023.