Sowing the Seeds of Confidence: Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds

Anxiety Clinical Trial

— StS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556331
• Other study ID #: 19/LO/1438 v7 01062020
• Status: Completed
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: September 2020
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 31, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Parenting

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United Kingdom	South London and Maudsley NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Total across recruitment period (up to 11 weeks, October 2020 to mid December 2020)
Primary	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.	Total across intervention period (up to 9 weeks, mid October 2020 to mid December 2020)
Primary	Number of participants who provided completed questionnaire measures	Percentage of recruited participants who completed questionnaire measures at each of the three collection timepoints.	Total across intervention and 6 week follow-up period (up to 15 weeks, mid October 2020 to January 2021)
Primary	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)	Collected twice: immediately after intervention attendance (same day) and after 6 weeks.
Primary	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	Collected twice: immediately after intervention attendance (same day) and after 6 weeks.
Secondary	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.	Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
Secondary	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.	Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.
Secondary	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.	Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.