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The training and nurturing support for mothers study

A pragmatic randomised controlled cost-effectiveness study of Well Parent Japan for Japanese mothers of children with Attention Deficit Hyperactivity Disorder (ADHD): the TRaining And Nurturing Support FOR Mothers (TRANSFORM) study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66978270
Enrollment
120
Registered
2020-03-16
Start date
2019-08-13
Completion date
Unknown
Last updated
2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder (ADHD) Mental and Behavioural Disorders Disturbance of activity and attention

Interventions

Well Parent Japan is a 13-session group-based intervention for parents of children with ADHD. The program includes an orientation to the intervention and psycho-education about ADHD, four sessions dev
Shimabukuro et al 2017
Shimabukuro et al 2020). Participants are randomly allocated into one of two groups. The method of randomization is at the individual level using a random number generator at the University of Nottin

Sponsors

Okinawa Institute of Science and Technology Graduate University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Mothers of children diagnosed with ADHD and the children themselves will be identified by health professionals working in hospitals or community clinics linked to the three research sites in Japan. Inclusion criteria for mothers will be: 1. Fluency in Japanese (reading and writing) 2. Parenting a child, 6-12 years who is diagnosed with ADHD 3. Participation in a behavioural intervention for the mother is not contra-indicated as viewed by the referring clinician

Exclusion criteria

Exclusion criteria: 1. Children with very little pragmatic speech as judged by the referring clinician 2. Children with functional intellectual disability 3. Mothers who are currently or have recently taken part in other parenting intervention (within two months)

Design outcomes

Primary

MeasureTime frame
Parent stress measured by the Parent Stress Index (PSI) at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis T1: baseline, T2: 14 weeks, T3: 26 weeks, T4: 39 weeks, T5: 51 weeks

Secondary

MeasureTime frame
1. Parenting style measured by the Parenting Scale at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis 2. Parenting competence/efficacy measured by the Parenting Sense of Competence Scale (PSOC) at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis 3. Locus of control assessed using the Parental Locus of Control Scale (PLOC) at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis 4. Mother’s mood measured by BDI-2 at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis 5. Child’s ADHD symptoms measured by mother and teacher by the Swanson, Nolan & Pelham Scale SNAP at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis 6. Parent/caregiver and teacher perceptions of emotional and behavioural problems in children measured by the Child Behavior Check List (CBCL) and Teacher Rating Form (TRF) at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis 7. Child’s impairment in school performance and relationship measured by mother and teacher by the performance scale from the Vanderbilt Assessment Scale at T1, T2 and T3 for intervention group and T1, T2, T3, T4 and T5 for TAU group as TAU also receive intervention at the end of TAU to inform the predictors of outcome analysis 8. Child’s impairment in eight different domains of functioning measured by the Impairm

Countries

Japan

Contacts

Public ContactShizuka Shimsbukuro
shizuka.shimabukuro@oist.jp+81 (0)98 966 8814

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026