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

NCT04556331 | Completed

• 1 other identifier: 19/LO/1438 v7 01062020
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Parenting

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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.

• 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 Outcomes (3)

• Change in score on Brief Infant Toddler Social and Emotional Assessment (Briggs-Gowan, Carter et al. 2002)

  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)

  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.

  Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.

Interventions

Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety BEHAVIORAL

'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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

South London and Maudsley NHS Trust

London, SE8, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35983606 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Fiona Challacombe, PhD DClinPsy

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 21, 2020
• Study Start: September 25, 2020
• Primary Completion: January 20, 2021
• Study Completion: January 31, 2021
• Last Updated: February 18, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)