NCT05790343

Brief Summary

Emotional disorders are among the most common childhood mental health difficulties. The majority of adult emotional disorders begin before age 14 years. Most children and families across the population do not receive the proven evidence-based interventions available, particularly those from socially disadvantaged neighbourhoods and excluded, Black and Minoritised populations. Families from disadvantaged neighbourhoods, Black and minoritised communities can often feel judged, mistrustful, and blamed for their children's behavioural difficulties making them reluctant to engage in parenting supportEven when available, research shows that over one-third of parents receiving traditional specialist delivered evidence-based parenting do not gain the expected outcomes. Undertaking a group-based parenting intervention to help parents understand and deal with their children's anxiety issues. The aim of this study is to examine the feasibility and acceptability of a new parent-led parenting intervention, being a Parent Helping your Child (BAPHYC) that is intended to improve childhood anxiety and to use the findings to inform the planning and conduct of a definitive randomised control trial. Being a Parent- Helping your Child (BAPHYC) has been developed from two well-established evidence-based parenting programmes. It is a parent-led, group format manualised parenting programme intended to improve childhood anxiety in children aged 5-12 years consisting of eight two-hourly weekly sessions peer-facilitated by two trained parent group leaders. The particants of BAPHYC participants are mothers, fathers and other carers who have principal parenting responsibility for a child with anxiety. The specific study objectives are to:

  1. 1.Establish initial evidence about reach and engagement, delivery, acceptability and impact of BAPHYC
  2. 2.Establish the feasibility of proposed recruitment pathways and measure completion
  3. 3.Acquire a fine grain understanding of parents' experiences of the BAPHYC intervention, research procedures and themes arising from BAPHYC implementation.
  4. 4.Assess participant recruitment, engagement, intervention and measure completion, and intervention acceptability rates against a priori feasibility parameters.
  5. 5.Obtain data that will be used in future trial recruitment and planning.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

July 21, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

March 2, 2023

Last Update Submit

July 20, 2023

Conditions

Keywords

Peer led intervention

Outcome Measures

Primary Outcomes (1)

  • Child Anxiety Impact Scale for Parents - change is being assessed

    A 27-item parent-report measure assessing the impact of anxiety symptoms on the psychosocial functioning of children and adolescents (Langley, Bergman, McCracken, \& Piacentini, 2004). It provides a quantitative measure of anxiety related functional impairment related to specific situations from multiple psychosocial domains (School, Social, Home/Family). It was designed as both a baseline measure and to evaluate treatment response. The respondents are asked to rate how much difficulty the child has had completing each activity due to his or her anxiety symptoms during the last month. Each item is scored on a 4-point Likert scale ("0" not at all, "1" just a little, "2" pretty much, "3" very much). Sum of subscales, or overall total score of the scale

    "baseline, pre-intervention/procedure/surgery" and "immediately after the intervention/procedure/surgery"

Other Outcomes (7)

  • Treatment Acceptability Rating Scale

    "immediately after the intervention/procedure/surgery"

  • Concerns About My Child (CAMC) - Change is being assessed

    "baseline, pre-intervention/procedure/surgery" and "immediately after the intervention/procedure/surgery"

  • Parenting Scale (PS, 8) - Change is being assessed

    "baseline, pre-intervention/procedure/surgery" and "immediately after the intervention/procedure/surgery"

  • +4 more other outcomes

Study Arms (1)

BAPHYC

Parents of children, aged 5-12 years, who have anxiety problems.

Behavioral: BAPHYC

Interventions

BAPHYCBEHAVIORAL

Nine weekly peer led group meetings

BAPHYC

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parent or parental caregiver including non-biological caregiver, for index child aged 5-12 years

You may qualify if:

  • Parent/ primary caregiver, including non-biological caregiver, for index child aged 5-12 years.
  • Parent-reported difficulties and concerns in managing anxiety of an index child. In households with more than one child aged 5-12 years, we ask the parents to nominate an index child whose behaviour was of greatest concern.
  • Parent/ primary caregiver must have proficient written and spoken English.
  • Parent/ primary must have capacity to provide informed consent to participate.

You may not qualify if:

  • Families where the parent/ parental caregiver:
  • The nominated index child of the parent/ primary caregiver has a primary neurodevelopmental condition such as autism, for which parent is likely to require specialist parenting intervention.
  • The parent / primary caregiver is unable to attend weekly course sessions of the BAPHYC intervention.
  • The parent / primary caregiver is not living with the index child and is unlikely to have sufficient contact to implement parenting skills acquired during the BAPHYC intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersEmpowerment

Condition Hierarchy (Ancestors)

Mental DisordersSocial BehaviorBehavior

Study Officials

  • Crsipin Day

    South London and Maudsley NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Yirmiya

CONTACT

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 30, 2023

Study Start

September 1, 2023

Primary Completion

March 31, 2024

Study Completion

July 31, 2024

Last Updated

July 21, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

This is a feasibility study; process evalaution with a small, but targeted recrutiment sample set. We will only be looking at mechanisms of reach, engagement and delivery and completion rates. No planned detailed analysis of effect sizes will be conducted. We will share the protocol and participant information sheets.