AnxietyStSNCT04556331
Sowing the Seeds of Confidence: Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds
A study testing Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety in people with Anxiety and Parenting, run by King's College London at 1 site in United Kingdom.
Trial summary
To pilot a brief group early intervention aimed at reducing or preventing the intergenerational transmission of anxiety, with parents whose child is between 12 and 47 months. To explore feasibility and acceptability of such an intervention with this population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Sep 2020to 31 Jan 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- current or recent (within 2 years) primary diagnosis of anxiety disorder or self-report of clinically impairing anxiety problem within last 2 years,
- parent of child aged 12-47 months at time of intervention,
- access to an internet connection and smart phone/computer will be required to take part,
- male or female,
- resident in England,
- and over the age of 18
Who cannot join
- current severe co-morbid diagnoses, e.g. psychosis or acute suicidal risk (as the nature of the intervention is brief and in a group, the level of support needed to keep those with severe mental health disorders safe will not be available),
- current alcohol or drugs misuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds With the Aim of Reducing Transmission of Anxiety Through Generations: A Feasibility Study
To pilot a brief group early intervention aimed at reducing or preventing the intergenerational transmission of anxiety, with parents whose child is between 12 and 47 months. To explore feasibility and acceptability of such an intervention with this population.
Read the detailed description
All participants will attend two group sessions of 'psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. The two sessions will be delivered online via Microsoft Teams, last 2 hours each and will run one week apart. Outcome and acceptability measures will be collected before, immediately after, and 6 weeks after the intervention. Feasibility data (e.g. drop-out rate) will be recorded.
- Being tested
- Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxietyBehavioural
'Psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. These will be shared with a group of maximum 8 remotely delivered, in a didactic format.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who consented to take part as percentage of those who expressed initial interest.
Percentage of count (people consent to take part / people expressing interest in response to advertising). To indicate feasibility of larger trial.
Measured: Total across recruitment period (up to 11 weeks, October 2020 to mid December 2020)
Actual attendance at each session as percentage of expected attendance
Percentage of count (people scheduled to attend each session / people who actually attended). To indicate feasibility of larger trial.
Measured: Total across intervention period (up to 9 weeks, mid October 2020 to mid December 2020)
Number of participants who provided completed questionnaire measures
Percentage of recruited participants who completed questionnaire measures at each of the three collection timepoints.
Measured: Total across intervention and 6 week follow-up period (up to 15 weeks, mid October 2020 to January 2021)
Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017)
Validated measure of acceptability of an intervention - Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017)
Measured: Collected twice: immediately after intervention attendance (same day) and after 6 weeks.
Open text questions about participants' views on the acceptability
Open text questions to gather qualitative information about participants' perspectives on usefulness, accessibility and unintended negative consequences
Measured: Collected twice: immediately after intervention attendance (same day) and after 6 weeks.
Secondary outcomes (3)
Change in score on Brief Infant Toddler Social and Emotional Assessment (Briggs-Gowan, Carter et al. 2002)
Parent report measure of child social, emotional and behavioural difficulties. This is a 42-item parent-report screening tool validated with parents of children aged 12 to 47 months. Maximum score is 84 and minimum score is 0. The higher the score the worse the outcome.
Measured: Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
Change in score on Depression Anxiety Stress Scale (Henry and Crawford 2005)
Parent report questionnaire measure of stress, anxiety and depression in parents. This is a 21-item scale. The minimum score is 0 and the maximum score is 63, higher score is a worse outcome.
Measured: Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
Bespoke questionnaire about self-reported use and confidence in behaviours specifically targeted in intervention.
Bespoke questionnaire about 8 specific parenting behaviours targeted in the intervention, each rated on a 5-point Likert scale (4 are reverse scored). Minimum score is 0 and maximum score is 40. The higher the score the 'worse' the outcome.
Measured: Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start25 Sep 2020
- Primary completion20 Jan 2021
- Study completion31 Jan 2021
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 AnxietyStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Fiona Challacombe, PhD DClinPsy, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556331
- Sponsor's protocol ID
- 19/LO/1438 v7 01062020
- Acronym
- StS
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palmer E, Woolgar M, Carter B, Cartwright-Hatton S, Challacombe FL. Preventing anxiety in the children of anxious parents - feasibility of a brief, online, group intervention for parents of one- to three-year-olds. Child Adolesc Ment Health. 2023 Feb;28(1):33-41. doi: 10.1111/camh.12596. Epub 2022 Aug 18.
PubMed 35983606
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds With the Aim of Reducing Transmission of Anxiety Through Generations: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04556331
- Acronym / sponsor ID
- StS / 19/LO/1438 v7 01062020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 21 Sep 2020 (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.
To pilot a brief group early intervention aimed at reducing or preventing the intergenerational transmission of anxiety, with parents whose child is between 12 and 47 months. To explore feasibility and acceptability of such an intervention with this population.
Detailed description
All participants will attend two group sessions of 'psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. The two sessions will be delivered online via Microsoft Teams, last 2 hours each and will run one week apart. Outcome and acceptability measures will be collected before, immediately after, and 6 weeks after the intervention. Feasibility data (e.g. drop-out rate) will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- current or recent (within 2 years) primary diagnosis of anxiety disorder or self-report of clinically impairing anxiety problem within last 2 years,
- parent of child aged 12-47 months at time of intervention,
- access to an internet connection and smart phone/computer will be required to take part,
- male or female,
- resident in England,
Key exclusion criteria (2 listed)
- current severe co-morbid diagnoses, e.g. psychosis or acute suicidal risk (as the nature of the intervention is brief and in a group, the level of support needed to keep those with severe mental health disorders safe will not be available),
- current alcohol or drugs misuse
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 |
|---|---|---|
| Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety'Psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. These will be shared with a group of maximum 8 remotely delivered, in a didactic format. | Behavioural | – |
Primary outcome
Number of participants who consented to take part as percentage of those who expressed initial interest.
Time frame: Total across recruitment period (up to 11 weeks, October 2020 to mid December 2020)
Percentage of count (people consent to take part / people expressing interest in response to advertising). To indicate feasibility of larger trial.
Actual attendance at each session as percentage of expected attendance
Time frame: Total across intervention period (up to 9 weeks, mid October 2020 to mid December 2020)
Percentage of count (people scheduled to attend each session / people who actually attended). To indicate feasibility of larger trial.
Number of participants who provided completed questionnaire measures
Time frame: Total across intervention and 6 week follow-up period (up to 15 weeks, mid October 2020 to January 2021)
Percentage of recruited participants who completed questionnaire measures at each of the three collection timepoints.
Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017)
Time frame: Collected twice: immediately after intervention attendance (same day) and after 6 weeks.
Validated measure of acceptability of an intervention - Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017)
Open text questions about participants' views on the acceptability
Time frame: Collected twice: immediately after intervention attendance (same day) and after 6 weeks.
Open text questions to gather qualitative information about participants' perspectives on usefulness, accessibility and unintended negative consequences
3 secondary outcomes
Change in score on Brief Infant Toddler Social and Emotional Assessment (Briggs-Gowan, Carter et al. 2002)
Time frame: Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
Change in score on Depression Anxiety Stress Scale (Henry and Crawford 2005)
Time frame: Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
Bespoke questionnaire about self-reported use and confidence in behaviours specifically targeted in intervention.
Time frame: Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
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 18 Feb 2021.
- Derived from this study: PubMed 35983606Palmer E, Woolgar M, Carter B, Cartwright-Hatton S, Challacombe FL. Preventing anxiety in the children of anxious parents - feasibility of a brief, online, group intervention for parents of one- to three-year-olds. Child Adolesc Ment Health. 2023 Feb;28(1):33-41. doi: 10.1111/camh.12596. Epub 2022 Aug 18.
- Individual participant dataSharing planned: No
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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.
Fiona Challacombe, PhD DClinPsy principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety in people with Anxiety and Parenting, run by King's College London 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 2 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 18 Feb 2021. 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?
Number of participants who consented to take part as percentage of those who expressed initial interest. (time frame: Total across recruitment period (up to 11 weeks, October 2020 to mid December 2020)). The study lists 5 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 NCT04556331, 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 18 Feb 2021.